Trial Outcomes & Findings for A Study to Learn About the Study Medicine (PF-06823859) in Adults With Active CLE or SLE With Skin Symptoms. (NCT NCT05879718)
NCT ID: NCT05879718
Last Updated: 2026-08-11
Results Overview
Change from baseline GS was calculated as GS(t) - GS(0), where GS(t) was the gene signature score at Week 12 and GS(0) was the gene signature score at Baseline, where the GS(t) was calculated as the mean of log2 transformed counts per million reads from each of 13 genes in RNAseq, the higher GS indicated coordinated higher expression. There is no minimum/maximum limit to the GS score. Gene expression was quantified using RNA sequencing and summarized as log2-transformed counts per million mapped reads \[log2(CPM)\]. Higher values indicate higher normalized gene expression and without a bounded scale or defined minimum or maximum value.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2026-08-11
Participant Flow
Initially participants were randomized to receive PF-06823859 or placebo in Period 1. In Period 2, participants in PF-06823859 group continued to receive the same, while participants who received placebo, depending upon the response, either continued receiving placebo (if responded to treatment) or were administered with PF-06823859 (non-responders). No participants continued to receive placebo in Period 2.
As per Sponsor's decision, dose strength of PF-06823859 is not disclosed and is designated as "Dose A" in every section of the record. The study was terminated due to sponsor decision and was not due to safety concerns or clinical effect reasons or request from any regulatory authorities.
Participant milestones
| Measure |
PF-06823859 Q4W Then PF-06823859 Q8W
Participants were randomized and administered with PF-06823859 at Dose A as intravenous (IV) infusion every 4 weeks (Q4W) till Week 8, followed by assessments till Week 12 (Period 1). Participants then continued receiving PF-06823859 at Dose A as IV infusion every 8 weeks (Q8W) from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
Placebo Q4W Then PF-06823859 Q8W
Participants were randomized and administered with placebo for PF-06823859 as IV infusion Q4W till Week 8, followed by assessments till Week 12 at Q4W (Period 1). Participants who did not respond to placebo in Period 1, were administered with PF-06823859 at Dose A as IV infusion Q8W from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
|---|---|---|
|
Period 1 (Day 1 to Pre-dose on Week 16)
STARTED
|
6
|
2
|
|
Period 1 (Day 1 to Pre-dose on Week 16)
COMPLETED
|
6
|
2
|
|
Period 1 (Day 1 to Pre-dose on Week 16)
NOT COMPLETED
|
0
|
0
|
|
Period 2 (Post-dose on Week 16-Week 48)
STARTED
|
6
|
2
|
|
Period 2 (Post-dose on Week 16-Week 48)
COMPLETED
|
3
|
1
|
|
Period 2 (Post-dose on Week 16-Week 48)
NOT COMPLETED
|
3
|
1
|
|
Follow-up Phase (Post Week 48-Week 60)
STARTED
|
6
|
2
|
|
Follow-up Phase (Post Week 48-Week 60)
COMPLETED
|
5
|
1
|
|
Follow-up Phase (Post Week 48-Week 60)
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
PF-06823859 Q4W Then PF-06823859 Q8W
Participants were randomized and administered with PF-06823859 at Dose A as intravenous (IV) infusion every 4 weeks (Q4W) till Week 8, followed by assessments till Week 12 (Period 1). Participants then continued receiving PF-06823859 at Dose A as IV infusion every 8 weeks (Q8W) from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
Placebo Q4W Then PF-06823859 Q8W
Participants were randomized and administered with placebo for PF-06823859 as IV infusion Q4W till Week 8, followed by assessments till Week 12 at Q4W (Period 1). Participants who did not respond to placebo in Period 1, were administered with PF-06823859 at Dose A as IV infusion Q8W from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
|---|---|---|
|
Period 2 (Post-dose on Week 16-Week 48)
Study terminated by sponsor
|
2
|
0
|
|
Period 2 (Post-dose on Week 16-Week 48)
Withdrawal by Subject
|
1
|
1
|
|
Follow-up Phase (Post Week 48-Week 60)
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
A Study to Learn About the Study Medicine (PF-06823859) in Adults With Active CLE or SLE With Skin Symptoms.
Baseline characteristics by cohort
| Measure |
PF-06823859 Q4W Then PF-06823859 Q8W
n=6 Participants
Participants were randomized and administered with PF-06823859 at Dose A as IV infusion Q4W till Week 8, followed by assessments till Week 12 (Period 1). Participants then continued receiving PF-06823859 at Dose A as IV infusion Q8W from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
Placebo Q4W Then PF-06823859 Q8W
n=2 Participants
Participants were randomized and administered with placebo for PF-06823859 as IV infusion Q4W till Week 8, followed by assessments till Week 12 at Q4W (Period 1). Participants who did not respond to placebo in Period 1, were administered with PF-06823859 at Dose A as IV infusion Q8W from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.83 Years
STANDARD_DEVIATION 7.25 • n=54 Participants
|
48.0 Years
STANDARD_DEVIATION 15.56 • n=54 Participants
|
49.38 Years
STANDARD_DEVIATION 8.53 • n=27 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=54 Participants
|
1 Participants
n=54 Participants
|
5 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=54 Participants
|
1 Participants
n=54 Participants
|
3 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=54 Participants
|
1 Participants
n=54 Participants
|
3 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=54 Participants
|
1 Participants
n=54 Participants
|
5 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=54 Participants
|
2 Participants
n=54 Participants
|
7 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Primary analysis set (PAS) included participants according to the study treatment they received. Participants with two consecutive missed doses of treatment or exposure to a new or protocol prohibited medication by Week 12 were excluded.
Change from baseline GS was calculated as GS(t) - GS(0), where GS(t) was the gene signature score at Week 12 and GS(0) was the gene signature score at Baseline, where the GS(t) was calculated as the mean of log2 transformed counts per million reads from each of 13 genes in RNAseq, the higher GS indicated coordinated higher expression. There is no minimum/maximum limit to the GS score. Gene expression was quantified using RNA sequencing and summarized as log2-transformed counts per million mapped reads \[log2(CPM)\]. Higher values indicate higher normalized gene expression and without a bounded scale or defined minimum or maximum value.
Outcome measures
| Measure |
PF-06823859 Q4W Then PF-06823859 Q8W
n=5 Participants
Participants were randomized and administered with PF-06823859 at Dose A as IV infusion Q4W till Week 8, followed by assessments till Week 12 (Period 1). Participants then continued receiving PF-06823859 at Dose A as IV infusion Q8W from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
Placebo Q4W Then PF-06823859 Q8W
n=2 Participants
Participants were randomized and administered with placebo for PF-06823859 as IV infusion Q4W till Week 8, followed by assessments till Week 12 at Q4W (Period 1). Participants who did not respond to placebo in Period 1, were administered with PF-06823859 at Dose A as IV infusion Q8W from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
Placebo (at Q4W)
Participants were administered with placebo for PF-06823859 as IV infusion Q4W till Week 8, followed by assessment till Week 12 (Period 1).
|
Placebo (at Q4W) Then PF-06823859 (at Q8W)
Participants who previously received with placebo for PF-06823859 at Q4W, were administered with PF-06823859 at Dose A as IV infusion Q8W from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
|---|---|---|---|---|
|
Change From Baseline in Type 1 Interferon (IFN) Gene Signature (GS) Score in Lesional Skin at Week 12
|
-1.1 log2(CPM) units
Interval -3.0 to 0.8
|
-1.6 log2(CPM) units
Interval -4.9 to 1.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full analysis set (FAS) included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
CLASI-A measures erythema and scaling or hypertrophy in thirteen skin regions. CLASI-A scores ranges from 0 to 70, with higher scores indicating more severe skin disease.
Outcome measures
| Measure |
PF-06823859 Q4W Then PF-06823859 Q8W
n=6 Participants
Participants were randomized and administered with PF-06823859 at Dose A as IV infusion Q4W till Week 8, followed by assessments till Week 12 (Period 1). Participants then continued receiving PF-06823859 at Dose A as IV infusion Q8W from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
Placebo Q4W Then PF-06823859 Q8W
n=2 Participants
Participants were randomized and administered with placebo for PF-06823859 as IV infusion Q4W till Week 8, followed by assessments till Week 12 at Q4W (Period 1). Participants who did not respond to placebo in Period 1, were administered with PF-06823859 at Dose A as IV infusion Q8W from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
Placebo (at Q4W)
Participants were administered with placebo for PF-06823859 as IV infusion Q4W till Week 8, followed by assessment till Week 12 (Period 1).
|
Placebo (at Q4W) Then PF-06823859 (at Q8W)
Participants who previously received with placebo for PF-06823859 at Q4W, were administered with PF-06823859 at Dose A as IV infusion Q8W from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (CLASI-A) Score at Week 12
|
-35.6 Percent change
Standard Deviation 21.28
|
-8.2 Percent change
Standard Deviation 5.41
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 16, 20, 24, 32, 40, 48 and 60Population: FAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention. One participant was available at Week 60 whose CLASI-A assessment was not conduced at the trial site, this was recorded as a protocol deviation. Therefore, the "Number analyzed" at Week 60 in the "Placebo Then PF-06823859" reporting group was "0". Here, "Number Analyzed" signifies participants evaluable at specified time points.
CLASI-A measures erythema and scaling or hypertrophy in thirteen skin regions. CLASI-A scores ranges from 0 to 70, with higher scores indicating more severe skin disease. Participants receiving PF-06823859 continued Q4W then Q8W treatment, while both participants receiving placebo switched to PF-06823859 at Week 16. Results are reported by treatment sequence to reflect protocol pathways and maintained the initial randomized comparison.
Outcome measures
| Measure |
PF-06823859 Q4W Then PF-06823859 Q8W
n=6 Participants
Participants were randomized and administered with PF-06823859 at Dose A as IV infusion Q4W till Week 8, followed by assessments till Week 12 (Period 1). Participants then continued receiving PF-06823859 at Dose A as IV infusion Q8W from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
Placebo Q4W Then PF-06823859 Q8W
n=2 Participants
Participants were randomized and administered with placebo for PF-06823859 as IV infusion Q4W till Week 8, followed by assessments till Week 12 at Q4W (Period 1). Participants who did not respond to placebo in Period 1, were administered with PF-06823859 at Dose A as IV infusion Q8W from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
Placebo (at Q4W)
Participants were administered with placebo for PF-06823859 as IV infusion Q4W till Week 8, followed by assessment till Week 12 (Period 1).
|
Placebo (at Q4W) Then PF-06823859 (at Q8W)
Participants who previously received with placebo for PF-06823859 at Q4W, were administered with PF-06823859 at Dose A as IV infusion Q8W from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
|---|---|---|---|---|
|
Percent Change From Baseline in CLASI-A Score at Weeks 4, 8, 16, 20, 24, 32, 40, 48 and 60
Week 4
|
-7.7 Percent change
Standard Deviation 32.09
|
-44.3 Percent change
Standard Deviation 50.42
|
—
|
—
|
|
Percent Change From Baseline in CLASI-A Score at Weeks 4, 8, 16, 20, 24, 32, 40, 48 and 60
Week 8
|
-22.8 Percent change
Standard Deviation 23.14
|
-12.3 Percent change
Standard Deviation 5.16
|
—
|
—
|
|
Percent Change From Baseline in CLASI-A Score at Weeks 4, 8, 16, 20, 24, 32, 40, 48 and 60
Week 16
|
-27.9 Percent change
Standard Deviation 41.0
|
11.7 Percent change
Standard Deviation 28.78
|
—
|
—
|
|
Percent Change From Baseline in CLASI-A Score at Weeks 4, 8, 16, 20, 24, 32, 40, 48 and 60
Week 20
|
-29.8 Percent change
Standard Deviation 33.23
|
-28.7 Percent change
Standard Deviation 15.99
|
—
|
—
|
|
Percent Change From Baseline in CLASI-A Score at Weeks 4, 8, 16, 20, 24, 32, 40, 48 and 60
Week 24
|
-23.9 Percent change
Standard Deviation 39.72
|
-22.2 Percent change
Standard Deviation 25.21
|
—
|
—
|
|
Percent Change From Baseline in CLASI-A Score at Weeks 4, 8, 16, 20, 24, 32, 40, 48 and 60
Week 32
|
-22.8 Percent change
Standard Deviation 37.41
|
-40.2 Percent change
Standard Deviation 50.67
|
—
|
—
|
|
Percent Change From Baseline in CLASI-A Score at Weeks 4, 8, 16, 20, 24, 32, 40, 48 and 60
Week 40
|
-7.6 Percent change
Standard Deviation 34.49
|
-64.0 Percent change
|
—
|
—
|
|
Percent Change From Baseline in CLASI-A Score at Weeks 4, 8, 16, 20, 24, 32, 40, 48 and 60
Week 48
|
-5.4 Percent change
Standard Deviation 34.93
|
-68.0 Percent change
|
—
|
—
|
|
Percent Change From Baseline in CLASI-A Score at Weeks 4, 8, 16, 20, 24, 32, 40, 48 and 60
Week 60
|
-24.2 Percent change
Standard Deviation 39.22
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60Population: FAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention. One participant was available at Week 60 whose CLASI-A assessment was not conduced at the trial site, this was recorded as a protocol deviation. Therefore, the "Number analyzed" at Week 60 in the "Placebo Then PF-06823859" reporting group was "0". Here, "Number Analyzed" signifies participants evaluable at specified time points.
CLASI-A measures erythema and scaling or hypertrophy in thirteen skin regions. CLASI-A scores ranges from 0 to 70, with higher scores indicating more severe skin disease. Participants receiving PF-06823859 continued Q4W then Q8W treatment, while both participants receiving placebo switched to PF-06823859 at Week 16. Results are reported by treatment sequence to reflect protocol pathways and maintained the initial randomized comparison.
Outcome measures
| Measure |
PF-06823859 Q4W Then PF-06823859 Q8W
n=6 Participants
Participants were randomized and administered with PF-06823859 at Dose A as IV infusion Q4W till Week 8, followed by assessments till Week 12 (Period 1). Participants then continued receiving PF-06823859 at Dose A as IV infusion Q8W from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
Placebo Q4W Then PF-06823859 Q8W
n=2 Participants
Participants were randomized and administered with placebo for PF-06823859 as IV infusion Q4W till Week 8, followed by assessments till Week 12 at Q4W (Period 1). Participants who did not respond to placebo in Period 1, were administered with PF-06823859 at Dose A as IV infusion Q8W from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
Placebo (at Q4W)
Participants were administered with placebo for PF-06823859 as IV infusion Q4W till Week 8, followed by assessment till Week 12 (Period 1).
|
Placebo (at Q4W) Then PF-06823859 (at Q8W)
Participants who previously received with placebo for PF-06823859 at Q4W, were administered with PF-06823859 at Dose A as IV infusion Q8W from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
|---|---|---|---|---|
|
Change From Baseline in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 4
|
-1.8 Score on a scale
Standard Deviation 5.04
|
-11.0 Score on a scale
Standard Deviation 12.73
|
—
|
—
|
|
Change From Baseline in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 8
|
-4.5 Score on a scale
Standard Deviation 4.28
|
-3.0 Score on a scale
Standard Deviation 1.41
|
—
|
—
|
|
Change From Baseline in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 12
|
-7.0 Score on a scale
Standard Deviation 5.66
|
-2.0 Score on a scale
Standard Deviation 1.41
|
—
|
—
|
|
Change From Baseline in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 16
|
-6.5 Score on a scale
Standard Deviation 8.12
|
3.0 Score on a scale
Standard Deviation 7.07
|
—
|
—
|
|
Change From Baseline in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 20
|
-5.8 Score on a scale
Standard Deviation 6.49
|
-7.0 Score on a scale
Standard Deviation 4.24
|
—
|
—
|
|
Change From Baseline in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 24
|
-5.8 Score on a scale
Standard Deviation 8.54
|
-5.5 Score on a scale
Standard Deviation 6.36
|
—
|
—
|
|
Change From Baseline in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 32
|
-4.8 Score on a scale
Standard Deviation 5.89
|
-10.0 Score on a scale
Standard Deviation 12.73
|
—
|
—
|
|
Change From Baseline in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 40
|
-3.3 Score on a scale
Standard Deviation 7.27
|
-16.0 Score on a scale
|
—
|
—
|
|
Change From Baseline in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 48
|
-2.0 Score on a scale
Standard Deviation 6.98
|
-17.0 Score on a scale
|
—
|
—
|
|
Change From Baseline in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 60
|
-7.3 Score on a scale
Standard Deviation 9.02
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60Population: FAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention. One participant was available at Week 60 whose CLASI-A assessment was not conduced at the trial site, this was recorded as a protocol deviation. Therefore, the "Number analyzed" at Week 60 in the "Placebo Then PF-06823859" reporting group was "0". Here, "Number Analyzed" signifies participants evaluable at specified time points.
CLASI-A measures erythema and scaling or hypertrophy in thirteen skin regions. CLASI-A scores ranges from 0 to 70, with higher scores indicating more severe skin disease. Percentage of participants with \>=50 percent reduction in CLASI-A score at the specified timepoints was reported in this outcome measure. Participants receiving PF-06823859 continued Q4W then Q8W treatment, while both participants receiving placebo switched to PF-06823859 at Week 16. Results are reported by treatment sequence to reflect protocol pathways and maintained the initial randomized comparison.
Outcome measures
| Measure |
PF-06823859 Q4W Then PF-06823859 Q8W
n=6 Participants
Participants were randomized and administered with PF-06823859 at Dose A as IV infusion Q4W till Week 8, followed by assessments till Week 12 (Period 1). Participants then continued receiving PF-06823859 at Dose A as IV infusion Q8W from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
Placebo Q4W Then PF-06823859 Q8W
n=2 Participants
Participants were randomized and administered with placebo for PF-06823859 as IV infusion Q4W till Week 8, followed by assessments till Week 12 at Q4W (Period 1). Participants who did not respond to placebo in Period 1, were administered with PF-06823859 at Dose A as IV infusion Q8W from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
Placebo (at Q4W)
Participants were administered with placebo for PF-06823859 as IV infusion Q4W till Week 8, followed by assessment till Week 12 (Period 1).
|
Placebo (at Q4W) Then PF-06823859 (at Q8W)
Participants who previously received with placebo for PF-06823859 at Q4W, were administered with PF-06823859 at Dose A as IV infusion Q8W from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
|---|---|---|---|---|
|
Percentage of Participants With Greater Than or Equal to (>=) 50 Percent Reduction in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 4
|
16.7 Percentage of Participants
Interval 0.9 to 58.2
|
50.0 Percentage of Participants
Interval 2.5 to 97.5
|
—
|
—
|
|
Percentage of Participants With Greater Than or Equal to (>=) 50 Percent Reduction in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 8
|
16.7 Percentage of Participants
Interval 0.9 to 58.2
|
0 Percentage of Participants
Interval 0.0 to 77.6
|
—
|
—
|
|
Percentage of Participants With Greater Than or Equal to (>=) 50 Percent Reduction in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 12
|
33.3 Percentage of Participants
Interval 6.3 to 72.9
|
0 Percentage of Participants
Interval 0.0 to 77.6
|
—
|
—
|
|
Percentage of Participants With Greater Than or Equal to (>=) 50 Percent Reduction in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 16
|
33.3 Percentage of Participants
Interval 6.3 to 72.9
|
0 Percentage of Participants
Interval 0.0 to 77.6
|
—
|
—
|
|
Percentage of Participants With Greater Than or Equal to (>=) 50 Percent Reduction in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 20
|
33.3 Percentage of Participants
Interval 6.3 to 72.9
|
0 Percentage of Participants
Interval 0.0 to 77.6
|
—
|
—
|
|
Percentage of Participants With Greater Than or Equal to (>=) 50 Percent Reduction in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 24
|
33.3 Percentage of Participants
Interval 6.3 to 72.9
|
0 Percentage of Participants
Interval 0.0 to 77.6
|
—
|
—
|
|
Percentage of Participants With Greater Than or Equal to (>=) 50 Percent Reduction in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 32
|
20.0 Percentage of Participants
Interval 1.0 to 65.7
|
50.0 Percentage of Participants
Interval 2.5 to 97.5
|
—
|
—
|
|
Percentage of Participants With Greater Than or Equal to (>=) 50 Percent Reduction in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 40
|
25.0 Percentage of Participants
Interval 1.3 to 75.1
|
100.0 Percentage of Participants
Interval 5.0 to 100.0
|
—
|
—
|
|
Percentage of Participants With Greater Than or Equal to (>=) 50 Percent Reduction in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 48
|
0 Percentage of Participants
Interval 0.0 to 52.7
|
100.0 Percentage of Participants
Interval 5.0 to 100.0
|
—
|
—
|
|
Percentage of Participants With Greater Than or Equal to (>=) 50 Percent Reduction in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 60
|
33.3 Percentage of Participants
Interval 1.7 to 86.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60Population: FAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention. One participant was available at Week 60 whose CLASI-A assessment was not conduced at the trial site, this was recorded as a protocol deviation. Therefore, the "Number analyzed" at Week 60 in the "Placebo Then PF-06823859" reporting group was "0". Here, "Number Analyzed" signifies participants evaluable at specified time points.
CLASI-A measures erythema and scaling or hypertrophy in thirteen skin regions. CLASI-A scores ranges from 0 to 70, with higher scores indicating more severe skin disease. Percentage of participants with \>=4 points reduction in CLASI-A score at the specified timepoints was reported in this outcome measure. Participants receiving PF-06823859 continued Q4W then Q8W treatment, while both participants receiving placebo switched to PF-06823859 at Week 16. Results are reported by treatment sequence to reflect protocol pathways and maintained the initial randomized comparison.
Outcome measures
| Measure |
PF-06823859 Q4W Then PF-06823859 Q8W
n=6 Participants
Participants were randomized and administered with PF-06823859 at Dose A as IV infusion Q4W till Week 8, followed by assessments till Week 12 (Period 1). Participants then continued receiving PF-06823859 at Dose A as IV infusion Q8W from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
Placebo Q4W Then PF-06823859 Q8W
n=2 Participants
Participants were randomized and administered with placebo for PF-06823859 as IV infusion Q4W till Week 8, followed by assessments till Week 12 at Q4W (Period 1). Participants who did not respond to placebo in Period 1, were administered with PF-06823859 at Dose A as IV infusion Q8W from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
Placebo (at Q4W)
Participants were administered with placebo for PF-06823859 as IV infusion Q4W till Week 8, followed by assessment till Week 12 (Period 1).
|
Placebo (at Q4W) Then PF-06823859 (at Q8W)
Participants who previously received with placebo for PF-06823859 at Q4W, were administered with PF-06823859 at Dose A as IV infusion Q8W from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
|---|---|---|---|---|
|
Percentage of Participants With >=4 Points Reduction in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 4
|
33.3 Percentage of Participants
Interval 6.3 to 72.9
|
50.0 Percentage of Participants
Interval 2.5 to 97.5
|
—
|
—
|
|
Percentage of Participants With >=4 Points Reduction in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 8
|
66.7 Percentage of Participants
Interval 27.1 to 93.7
|
50.0 Percentage of Participants
Interval 2.5 to 97.5
|
—
|
—
|
|
Percentage of Participants With >=4 Points Reduction in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 12
|
66.7 Percentage of Participants
Interval 27.1 to 93.7
|
0 Percentage of Participants
Interval 0.0 to 77.6
|
—
|
—
|
|
Percentage of Participants With >=4 Points Reduction in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 16
|
50.0 Percentage of Participants
Interval 15.3 to 84.7
|
0 Percentage of Participants
Interval 0.0 to 77.6
|
—
|
—
|
|
Percentage of Participants With >=4 Points Reduction in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 20
|
66.7 Percentage of Participants
Interval 27.1 to 93.7
|
100.0 Percentage of Participants
Interval 22.4 to 100.0
|
—
|
—
|
|
Percentage of Participants With >=4 Points Reduction in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 24
|
50.0 Percentage of Participants
Interval 15.3 to 84.7
|
50.0 Percentage of Participants
Interval 2.5 to 97.5
|
—
|
—
|
|
Percentage of Participants With >=4 Points Reduction in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 32
|
60.0 Percentage of Participants
Interval 18.9 to 92.4
|
50.0 Percentage of Participants
Interval 2.5 to 97.5
|
—
|
—
|
|
Percentage of Participants With >=4 Points Reduction in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 40
|
50.0 Percentage of Participants
Interval 9.8 to 90.2
|
100.0 Percentage of Participants
Interval 5.0 to 100.0
|
—
|
—
|
|
Percentage of Participants With >=4 Points Reduction in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 48
|
25.0 Percentage of Participants
Interval 1.3 to 75.1
|
100.0 Percentage of Participants
Interval 5.0 to 100.0
|
—
|
—
|
|
Percentage of Participants With >=4 Points Reduction in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 60
|
66.7 Percentage of Participants
Interval 13.5 to 98.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60Population: FAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention. One participant was available at Week 60 whose CLASI-A assessment was not conduced at the trial site, this was recorded as a protocol deviation. Therefore, the "Number analyzed" at Week 60 in the "Placebo Then PF-06823859" reporting group was "0". Here, "Number Analyzed" signifies participants evaluable at specified time points.
CLASI-A measures erythema and scaling or hypertrophy in thirteen skin regions. CLASI-A scores ranges from 0 to 70, with higher scores indicating more severe skin disease. Percentage of participants with \>=7 points reduction in CLASI-A score at the specified timepoints was reported in this outcome measure. Participants receiving PF-06823859 continued Q4W then Q8W treatment, while both participants receiving placebo switched to PF-06823859 at Week 16. Results are reported by treatment sequence to reflect protocol pathways and maintained the initial randomized comparison.
Outcome measures
| Measure |
PF-06823859 Q4W Then PF-06823859 Q8W
n=6 Participants
Participants were randomized and administered with PF-06823859 at Dose A as IV infusion Q4W till Week 8, followed by assessments till Week 12 (Period 1). Participants then continued receiving PF-06823859 at Dose A as IV infusion Q8W from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
Placebo Q4W Then PF-06823859 Q8W
n=2 Participants
Participants were randomized and administered with placebo for PF-06823859 as IV infusion Q4W till Week 8, followed by assessments till Week 12 at Q4W (Period 1). Participants who did not respond to placebo in Period 1, were administered with PF-06823859 at Dose A as IV infusion Q8W from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
Placebo (at Q4W)
Participants were administered with placebo for PF-06823859 as IV infusion Q4W till Week 8, followed by assessment till Week 12 (Period 1).
|
Placebo (at Q4W) Then PF-06823859 (at Q8W)
Participants who previously received with placebo for PF-06823859 at Q4W, were administered with PF-06823859 at Dose A as IV infusion Q8W from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
|---|---|---|---|---|
|
Percentage of Participants With >=7 Points Reduction in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 4
|
16.7 Percentage of Participants
Interval 0.9 to 58.2
|
50.0 Percentage of Participants
Interval 2.5 to 97.5
|
—
|
—
|
|
Percentage of Participants With >=7 Points Reduction in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 8
|
33.3 Percentage of Participants
Interval 6.3 to 72.9
|
0 Percentage of Participants
Interval 0.0 to 77.6
|
—
|
—
|
|
Percentage of Participants With >=7 Points Reduction in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 12
|
50.0 Percentage of Participants
Interval 15.3 to 84.7
|
0 Percentage of Participants
Interval 0.0 to 77.6
|
—
|
—
|
|
Percentage of Participants With >=7 Points Reduction in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 16
|
50.0 Percentage of Participants
Interval 15.3 to 84.7
|
0 Percentage of Participants
Interval 0.0 to 77.6
|
—
|
—
|
|
Percentage of Participants With >=7 Points Reduction in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 20
|
50.0 Percentage of Participants
Interval 15.3 to 84.7
|
50.0 Percentage of Participants
Interval 2.5 to 97.5
|
—
|
—
|
|
Percentage of Participants With >=7 Points Reduction in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 24
|
50.0 Percentage of Participants
Interval 15.3 to 84.7
|
50.0 Percentage of Participants
Interval 2.5 to 97.5
|
—
|
—
|
|
Percentage of Participants With >=7 Points Reduction in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 32
|
60.0 Percentage of Participants
Interval 18.9 to 92.4
|
50.0 Percentage of Participants
Interval 2.5 to 97.5
|
—
|
—
|
|
Percentage of Participants With >=7 Points Reduction in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 40
|
25.0 Percentage of Participants
Interval 1.3 to 75.1
|
100.0 Percentage of Participants
Interval 5.0 to 100.0
|
—
|
—
|
|
Percentage of Participants With >=7 Points Reduction in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 48
|
25.0 Percentage of Participants
Interval 1.3 to 75.1
|
100.0 Percentage of Participants
Interval 5.0 to 100.0
|
—
|
—
|
|
Percentage of Participants With >=7 Points Reduction in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 60
|
66.7 Percentage of Participants
Interval 13.5 to 98.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60Population: FAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention. Here, "Number Analyzed" signifies participants evaluable for the specified rows.
PhGA score was assigned by physician as the number within the 0 to 100 millimeter range on visual assessment scale and provided a global characterization of disease. Higher scores indicating more severe disease. Participants receiving PF-06823859 continued Q4W then Q8W treatment, while both participants receiving placebo switched to PF-06823859 at Week 16. Results are reported by treatment sequence to reflect protocol pathways and maintained the initial randomized comparison.
Outcome measures
| Measure |
PF-06823859 Q4W Then PF-06823859 Q8W
n=6 Participants
Participants were randomized and administered with PF-06823859 at Dose A as IV infusion Q4W till Week 8, followed by assessments till Week 12 (Period 1). Participants then continued receiving PF-06823859 at Dose A as IV infusion Q8W from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
Placebo Q4W Then PF-06823859 Q8W
n=2 Participants
Participants were randomized and administered with placebo for PF-06823859 as IV infusion Q4W till Week 8, followed by assessments till Week 12 at Q4W (Period 1). Participants who did not respond to placebo in Period 1, were administered with PF-06823859 at Dose A as IV infusion Q8W from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
Placebo (at Q4W)
Participants were administered with placebo for PF-06823859 as IV infusion Q4W till Week 8, followed by assessment till Week 12 (Period 1).
|
Placebo (at Q4W) Then PF-06823859 (at Q8W)
Participants who previously received with placebo for PF-06823859 at Q4W, were administered with PF-06823859 at Dose A as IV infusion Q8W from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
|---|---|---|---|---|
|
Change From Baseline in Physician Global Assessment (PhGA) Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 4
|
-11.7 Millimetre
Standard Deviation 23.07
|
-5.5 Millimetre
Standard Deviation 7.78
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PhGA) Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 8
|
-18.5 Millimetre
Standard Deviation 12.77
|
-7.0 Millimetre
Standard Deviation 9.9
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PhGA) Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 12
|
-25.0 Millimetre
Standard Deviation 23.19
|
13.0 Millimetre
Standard Deviation 19.8
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PhGA) Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 16
|
-19.8 Millimetre
Standard Deviation 28.52
|
20.5 Millimetre
Standard Deviation 27.58
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PhGA) Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 20
|
-26.7 Millimetre
Standard Deviation 26.82
|
22.0 Millimetre
Standard Deviation 31.11
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PhGA) Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 24
|
-24.7 Millimetre
Standard Deviation 30.74
|
16.0 Millimetre
Standard Deviation 24.04
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PhGA) Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 32
|
-24.8 Millimetre
Standard Deviation 35.17
|
5.5 Millimetre
Standard Deviation 21.92
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PhGA) Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 40
|
-25.3 Millimetre
Standard Deviation 34.44
|
4.0 Millimetre
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PhGA) Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 48
|
-21.0 Millimetre
Standard Deviation 35.36
|
-26.0 Millimetre
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PhGA) Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Week 60
|
-37.7 Millimetre
Standard Deviation 33.61
|
30.0 Millimetre
|
—
|
—
|
SECONDARY outcome
Timeframe: For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60Population: Safety analysis set (SAS) included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
Laboratory test included activated partial thromboplastin time prolonged, alanine aminotransferase increased, alkaline phosphatase increased, anemia, aspartate aminotransferase increased, blood bilirubin increased, creatine phosphokinase (CPK) increased, cholesterol high, creatinine increased, hemoglobin increased, hypercalcemia, hyperkalemia, hypernatremia, hypertriglyceridemia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, international normalized ratio (INR) increased, leukocytosis, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased and white blood cell decreased. Laboratory test abnormalities were graded according to CTCAE v5.0; grade 3=severe, grade 4=life-threatening consequences and grade 5=death. Participants with any laboratory abnormalities of CTCAE v5.0 grade 3 or more were reported in this outcome measure.
Outcome measures
| Measure |
PF-06823859 Q4W Then PF-06823859 Q8W
n=6 Participants
Participants were randomized and administered with PF-06823859 at Dose A as IV infusion Q4W till Week 8, followed by assessments till Week 12 (Period 1). Participants then continued receiving PF-06823859 at Dose A as IV infusion Q8W from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
Placebo Q4W Then PF-06823859 Q8W
n=6 Participants
Participants were randomized and administered with placebo for PF-06823859 as IV infusion Q4W till Week 8, followed by assessments till Week 12 at Q4W (Period 1). Participants who did not respond to placebo in Period 1, were administered with PF-06823859 at Dose A as IV infusion Q8W from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
Placebo (at Q4W)
n=2 Participants
Participants were administered with placebo for PF-06823859 as IV infusion Q4W till Week 8, followed by assessment till Week 12 (Period 1).
|
Placebo (at Q4W) Then PF-06823859 (at Q8W)
n=2 Participants
Participants who previously received with placebo for PF-06823859 at Q4W, were administered with PF-06823859 at Dose A as IV infusion Q8W from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities of Grade 3 or More According to Common Terminology Criteria for Adverse Events (CTCAE) Version (v) 5.0
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60Population: SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
Vital signs included systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate (PR). Clinically significant vital signs abnormalities were based on investigator's decision.
Outcome measures
| Measure |
PF-06823859 Q4W Then PF-06823859 Q8W
n=6 Participants
Participants were randomized and administered with PF-06823859 at Dose A as IV infusion Q4W till Week 8, followed by assessments till Week 12 (Period 1). Participants then continued receiving PF-06823859 at Dose A as IV infusion Q8W from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
Placebo Q4W Then PF-06823859 Q8W
n=6 Participants
Participants were randomized and administered with placebo for PF-06823859 as IV infusion Q4W till Week 8, followed by assessments till Week 12 at Q4W (Period 1). Participants who did not respond to placebo in Period 1, were administered with PF-06823859 at Dose A as IV infusion Q8W from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
Placebo (at Q4W)
n=2 Participants
Participants were administered with placebo for PF-06823859 as IV infusion Q4W till Week 8, followed by assessment till Week 12 (Period 1).
|
Placebo (at Q4W) Then PF-06823859 (at Q8W)
n=2 Participants
Participants who previously received with placebo for PF-06823859 at Q4W, were administered with PF-06823859 at Dose A as IV infusion Q8W from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Vital Signs Abnormalities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60Population: SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
ECG parameters included PR interval, QRS duration and QT interval using Fridericia's formula (QTcF) interval. Clinically significant abnormalities in ECG parameters were based on investigator's decision.
Outcome measures
| Measure |
PF-06823859 Q4W Then PF-06823859 Q8W
n=6 Participants
Participants were randomized and administered with PF-06823859 at Dose A as IV infusion Q4W till Week 8, followed by assessments till Week 12 (Period 1). Participants then continued receiving PF-06823859 at Dose A as IV infusion Q8W from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
Placebo Q4W Then PF-06823859 Q8W
n=6 Participants
Participants were randomized and administered with placebo for PF-06823859 as IV infusion Q4W till Week 8, followed by assessments till Week 12 at Q4W (Period 1). Participants who did not respond to placebo in Period 1, were administered with PF-06823859 at Dose A as IV infusion Q8W from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
Placebo (at Q4W)
n=2 Participants
Participants were administered with placebo for PF-06823859 as IV infusion Q4W till Week 8, followed by assessment till Week 12 (Period 1).
|
Placebo (at Q4W) Then PF-06823859 (at Q8W)
n=2 Participants
Participants who previously received with placebo for PF-06823859 at Q4W, were administered with PF-06823859 at Dose A as IV infusion Q8W from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Electrocardiogram (ECG) Results
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60Population: SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were the AEs with onset dates on or after the start of the study intervention up to after last dose of study intervention. An serious adverse event (SAE) was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or any other pre-specified criteria in protocol of the study or other important medical events. AEs included SAEs (if occurred) and all other AEs (including non-SAEs).
Outcome measures
| Measure |
PF-06823859 Q4W Then PF-06823859 Q8W
n=6 Participants
Participants were randomized and administered with PF-06823859 at Dose A as IV infusion Q4W till Week 8, followed by assessments till Week 12 (Period 1). Participants then continued receiving PF-06823859 at Dose A as IV infusion Q8W from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
Placebo Q4W Then PF-06823859 Q8W
n=6 Participants
Participants were randomized and administered with placebo for PF-06823859 as IV infusion Q4W till Week 8, followed by assessments till Week 12 at Q4W (Period 1). Participants who did not respond to placebo in Period 1, were administered with PF-06823859 at Dose A as IV infusion Q8W from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
Placebo (at Q4W)
n=2 Participants
Participants were administered with placebo for PF-06823859 as IV infusion Q4W till Week 8, followed by assessment till Week 12 (Period 1).
|
Placebo (at Q4W) Then PF-06823859 (at Q8W)
n=2 Participants
Participants who previously received with placebo for PF-06823859 at Q4W, were administered with PF-06823859 at Dose A as IV infusion Q8W from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and Who Discontinued Study Due to TEAEs
TESAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and Who Discontinued Study Due to TEAEs
TEAEs
|
4 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and Who Discontinued Study Due to TEAEs
Discontinued study due to TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
PF-06823859 (at Q4W)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
PF-06823859 (at Q4W) Then PF-06823859 (at Q8W)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo (at Q4W)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo (at Q4W) Then PF-06823859 (at Q8W)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PF-06823859 (at Q4W)
n=6 participants at risk
Participants were administered with PF-06823859 at Dose A as IV infusion Q4W till Week 8, followed by assessments till Week 12 (Period 1).
|
PF-06823859 (at Q4W) Then PF-06823859 (at Q8W)
n=6 participants at risk
Participants who previously received with PF-06823859 at Q4W, were administered with PF-06823859 at Dose A as IV infusion Q8W from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
Placebo (at Q4W)
n=2 participants at risk
Participants were administered with placebo for PF-06823859 as IV infusion Q4W till Week 8, followed by assessment till Week 12 (Period 1).
|
Placebo (at Q4W) Then PF-06823859 (at Q8W)
n=2 participants at risk
Participants who previously received with placebo for PF-06823859 at Q4W, were administered with PF-06823859 at Dose A as IV infusion Q8W from Week 16 till Week 40, followed by last full study assessments at Week 48 (Period 2). Eligible participants had a 12-week follow-up period.
|
|---|---|---|---|---|
|
Eye disorders
Dry eye
|
0.00%
0/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
16.7%
1/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
50.0%
1/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
|
Eye disorders
Vision blurred
|
16.7%
1/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Angular cheilitis
|
16.7%
1/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
16.7%
1/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
16.7%
1/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Pulpless tooth
|
0.00%
0/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
16.7%
1/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
|
General disorders
Asthenia
|
16.7%
1/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
16.7%
1/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
|
Immune system disorders
Food allergy
|
16.7%
1/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
|
Infections and infestations
COVID-19
|
0.00%
0/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
16.7%
1/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
50.0%
1/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
|
Infections and infestations
Cystitis
|
16.7%
1/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
|
Infections and infestations
Eye infection
|
0.00%
0/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
50.0%
1/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
|
Infections and infestations
Oral herpes
|
16.7%
1/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
16.7%
1/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
1/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
16.7%
1/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
50.0%
1/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
16.7%
1/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
16.7%
1/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
50.0%
1/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
16.7%
1/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
16.7%
1/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Diffuse alopecia
|
0.00%
0/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
16.7%
1/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
50.0%
1/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/6 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
0.00%
0/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
50.0%
1/2 • For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
SAS included participants randomly assigned to study intervention who received at least 1 dose of study intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER