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Trial Outcomes & Findings for A Proof-of-Activity Study With Orticumab in Subjects With Psoriasis and Cardiometabolic Risk Factors (NCT NCT04776629)

NCT ID: NCT04776629

Last Updated: 2026-05-11

Results Overview

Percentage of participants achieving treatment success (clear =0 or almost clear =1) and greater than or equal to (\>=) 2 Point Improvement at Week 15 on the sIGA scale

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

77 participants

Primary outcome timeframe

106 days (Week 15)

Results posted on

2026-05-11

Participant Flow

The trial was conducted at 21 clinical sites in the United States.

Participants were randomized 2:1 to receive orticumab or placebo.

Participant milestones

Participant milestones
Measure
Active Treatment
Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes. Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months.
Placebo
Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes. Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months.
Overall Study
STARTED
52
25
Overall Study
COMPLETED
40
20
Overall Study
NOT COMPLETED
12
5

Reasons for withdrawal

Reasons for withdrawal
Measure
Active Treatment
Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes. Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months.
Placebo
Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes. Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months.
Overall Study
COVID 19 infection
1
0
Overall Study
Lost to Follow-up
5
1
Overall Study
Withdrawal by Subject
5
4
Overall Study
Adverse Event
1
0

Baseline Characteristics

Intent-to-treat (ITT) analysis population included all randomized participants.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Active Treatment
n=52 Participants
Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes. Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months.
Placebo
n=25 Participants
Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes. Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months.
Total
n=77 Participants
Total of all reporting groups
Age, Continuous
52 years
STANDARD_DEVIATION 10.6 • n=44 Participants • Intent-to-treat (ITT) analysis population included all randomized participants.
50.5 years
STANDARD_DEVIATION 9.8 • n=10 Participants • Intent-to-treat (ITT) analysis population included all randomized participants.
51.5 years
STANDARD_DEVIATION 10.3 • n=30 Participants • Intent-to-treat (ITT) analysis population included all randomized participants.
Sex: Female, Male
Female
20 Participants
n=44 Participants • Intent-to-treat (ITT) analysis population included all randomized participants.
13 Participants
n=10 Participants • Intent-to-treat (ITT) analysis population included all randomized participants.
33 Participants
n=30 Participants • Intent-to-treat (ITT) analysis population included all randomized participants.
Sex: Female, Male
Male
32 Participants
n=44 Participants • Intent-to-treat (ITT) analysis population included all randomized participants.
12 Participants
n=10 Participants • Intent-to-treat (ITT) analysis population included all randomized participants.
44 Participants
n=30 Participants • Intent-to-treat (ITT) analysis population included all randomized participants.
Ethnicity (NIH/OMB)
Hispanic or Latino
31 Participants
n=44 Participants
18 Participants
n=10 Participants
49 Participants
n=30 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
21 Participants
n=44 Participants
7 Participants
n=10 Participants
28 Participants
n=30 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=44 Participants
0 Participants
n=10 Participants
0 Participants
n=30 Participants
Race/Ethnicity, Customized
White
48 Participants
n=44 Participants
23 Participants
n=10 Participants
71 Participants
n=30 Participants
Race/Ethnicity, Customized
Black
3 Participants
n=44 Participants
0 Participants
n=10 Participants
3 Participants
n=30 Participants
Race/Ethnicity, Customized
Asian
1 Participants
n=44 Participants
1 Participants
n=10 Participants
2 Participants
n=30 Participants
Race/Ethnicity, Customized
American Native
0 Participants
n=44 Participants
1 Participants
n=10 Participants
1 Participants
n=30 Participants

PRIMARY outcome

Timeframe: 106 days (Week 15)

Population: ITT analysis population included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data.

PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease)

Outcome measures

Outcome measures
Measure
Placebo
n=20 Participants
Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes. Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months.
Active Treatment
n=40 Participants
Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes. Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months.
Mean Percent Change From Baseline in Psoriasis Area Severity Index (PASI)
-18.95 Percentage change of score
Standard Deviation 25.165
-25.45 Percentage change of score
Standard Deviation 26.552

PRIMARY outcome

Timeframe: 106 days (Week 15)

Population: ITT analysis population included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data.

Percentage of participants achieving treatment success (clear =0 or almost clear =1) and greater than or equal to (\>=) 2 Point Improvement at Week 15 on the sIGA scale

Outcome measures

Outcome measures
Measure
Placebo
n=20 Participants
Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes. Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months.
Active Treatment
n=40 Participants
Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes. Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months.
Percentage of Participants Achieving Treatment Success by the 5-point Static Investigator's Global Assessment Modified 2011 Version (sIGA) Score
1 Participants
0.75
1 Participants
0.59

SECONDARY outcome

Timeframe: Weeks 1, 3, 7, and 11

Population: numbers of participants are different in some visits due to participants discontinued from the trial

PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease)

Outcome measures

Outcome measures
Measure
Placebo
n=25 Participants
Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes. Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months.
Active Treatment
n=52 Participants
Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes. Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months.
Mean Percent Change From Baseline in Psoriasis Area Severity Index (PASI)
Week 1
-1.24 PASI score % change
Standard Deviation 7.099
-3.46 PASI score % change
Standard Deviation 9.757
Mean Percent Change From Baseline in Psoriasis Area Severity Index (PASI)
Week 3
-8.28 PASI score % change
Standard Deviation 9.206
-12.94 PASI score % change
Standard Deviation 18.529
Mean Percent Change From Baseline in Psoriasis Area Severity Index (PASI)
week 7
-5.47 PASI score % change
Standard Deviation 15.341
-20.14 PASI score % change
Standard Deviation 21.340
Mean Percent Change From Baseline in Psoriasis Area Severity Index (PASI)
Week 11
-14.34 PASI score % change
Standard Deviation 17.159
-22.50 PASI score % change
Standard Deviation 23.844

SECONDARY outcome

Timeframe: Weeks 1, 3, 7, and 11

Population: numbers of participants are different in some visits due to participants discontinued from the trial

PASI75 is a 75 percent reduction in PASI score. PASI50 is a 50 percent reduction in PASI score

Outcome measures

Outcome measures
Measure
Placebo
n=25 Participants
Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes. Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months.
Active Treatment
n=52 Participants
Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes. Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months.
Percentage of Participants Achieving PASI75 and PASI50
Week 3 - PASI 50 · Achieved
0 Participants
2 Participants
Percentage of Participants Achieving PASI75 and PASI50
Week 3 - PASI 50 · Not achieved
21 Participants
46 Participants
Percentage of Participants Achieving PASI75 and PASI50
Week 3 - PASI 75 · Achieved
0 Participants
2 Participants
Percentage of Participants Achieving PASI75 and PASI50
Week 3 - PASI 75 · Not achieved
21 Participants
46 Participants
Percentage of Participants Achieving PASI75 and PASI50
Week 7 - PASI 50 · Achieved
0 Participants
5 Participants
Percentage of Participants Achieving PASI75 and PASI50
Week 7 - PASI 50 · Not achieved
22 Participants
40 Participants
Percentage of Participants Achieving PASI75 and PASI50
Week 7 - PASI 75 · Achieved
0 Participants
1 Participants
Percentage of Participants Achieving PASI75 and PASI50
Week 11 - PASI 75 · Achieved
0 Participants
2 Participants
Percentage of Participants Achieving PASI75 and PASI50
Week 11 - PASI 75 · Not achieved
21 Participants
42 Participants
Percentage of Participants Achieving PASI75 and PASI50
Week 1 - PASI 50 · Achieved
0 Participants
0 Participants
Percentage of Participants Achieving PASI75 and PASI50
Week 1 - PASI 50 · Not achieved
24 Participants
51 Participants
Percentage of Participants Achieving PASI75 and PASI50
Week 1 - PASI 75 · Achieved
0 Participants
0 Participants
Percentage of Participants Achieving PASI75 and PASI50
Week 1 - PASI 75 · Not achieved
24 Participants
51 Participants
Percentage of Participants Achieving PASI75 and PASI50
Week 7 - PASI 75 · Not achieved
22 Participants
44 Participants
Percentage of Participants Achieving PASI75 and PASI50
Week 11 - PASI 50 · Achieved
0 Participants
5 Participants
Percentage of Participants Achieving PASI75 and PASI50
Week 11 - PASI 50 · Not achieved
21 Participants
39 Participants

SECONDARY outcome

Timeframe: Weeks 1, 3, 7, 11, 15

Population: numbers of participants are different in some visits due to participants discontinued from the trial

Minimum: 0 percent, Maximum: 100 percent. Higher percentage indicates more skin with psoriasis.

Outcome measures

Outcome measures
Measure
Placebo
n=25 Participants
Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes. Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months.
Active Treatment
n=52 Participants
Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes. Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months.
Mean Percent Change in Baseline in Body Surface Area (BSA) % Involvement
Week 11
-4.99 percentage change of body surface
Standard Deviation 39.048
-14.34 percentage change of body surface
Standard Deviation 22.567
Mean Percent Change in Baseline in Body Surface Area (BSA) % Involvement
Week 15
-6.55 percentage change of body surface
Standard Deviation 37.072
-15.49 percentage change of body surface
Standard Deviation 27.099
Mean Percent Change in Baseline in Body Surface Area (BSA) % Involvement
Week 1
-1.93 percentage change of body surface
Standard Deviation 5.087
-1.02 percentage change of body surface
Standard Deviation 6.045
Mean Percent Change in Baseline in Body Surface Area (BSA) % Involvement
Week 3
-6.88 percentage change of body surface
Standard Deviation 10.516
-6.85 percentage change of body surface
Standard Deviation 18.220
Mean Percent Change in Baseline in Body Surface Area (BSA) % Involvement
Week 7
-0.66 percentage change of body surface
Standard Deviation 20.653
-13.51 percentage change of body surface
Standard Deviation 22.010

SECONDARY outcome

Timeframe: Weeks 3, 7, 11, 15

Population: numbers of participants are different in some visits due to participants discontinued from the trial

DLQI is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life).

Outcome measures

Outcome measures
Measure
Placebo
n=25 Participants
Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes. Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months.
Active Treatment
n=52 Participants
Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes. Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months.
Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score
Week 3
-2.0 score
Standard Deviation 4.07
-3.6 score
Standard Deviation 4.01
Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score
Week 7
-2.2 score
Standard Deviation 4.21
-3.5 score
Standard Deviation 4.39
Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score
Week 11
-2.8 score
Standard Deviation 4.93
-3.8 score
Standard Deviation 4.20
Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score
Week 15
-2.7 score
Standard Deviation 5.19
-4.1 score
Standard Deviation 4.5

SECONDARY outcome

Timeframe: Weeks 3 and 15

Population: numbers of participants are different in some visits due to participants discontinued from the trial

The Itch NRS is a self-administered subject reported outcome questionnaire that is completed during protocol specified clinic visits. Participants indicate itch severity by circling the integer that best describes the worst level of itching due to psoriasis in the past 24 h on an 11-point scale anchored at 0, representing 'no itching' and 10, representing 'worst itch imaginable'.

Outcome measures

Outcome measures
Measure
Placebo
n=25 Participants
Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes. Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months.
Active Treatment
n=52 Participants
Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes. Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months.
Mean Change From Baseline in Itch Numerical Rating Scale (INRS) Score
Week 3
6.7 scores on a scale
Standard Deviation 2.13
6.2 scores on a scale
Standard Deviation 2.55
Mean Change From Baseline in Itch Numerical Rating Scale (INRS) Score
Week 15
7.1 scores on a scale
Standard Deviation 2.59
6.1 scores on a scale
Standard Deviation 2.71

OTHER_PRE_SPECIFIED outcome

Timeframe: 106 days (Week 15)

Population: The difference between the number of participants analyzed and the participant flow is because the endpoint is analyzed based on participants with paired CCTA scans. Not all participants have analyzable paired CCTA scans from baseline and follow-up visit due to CCTA scan quality.

Change in coronary artery perivascular fat attenuation index (FAI) measured by coronary computed tomographic angiography (CCTA) as report in FAI-Score. \- Fat Attenuation Index score is a standardized measurement of coronary inflammation for each coronary artery (adjusted for age, sex as well as technical, biological, and anatomical characteristics) to allow individualized interpretation of the degree of coronary inflammation. FAI-Score range from 0-100. Higher FAI-Score means more inflammation. \- CaRi-Heart® Risk Score provides an individualized absolute risk of a fatal cardiac event within the next 8 years, incorporating: 1. Inflammation measured by FAI-Score 2. Plaque burden 3. Other clinical risk factors. CaRi-Heart Risk Score range from 0-100. It's a percentage that categorizes risk into three levels: Low (≤5%), Medium (5-10%), and High (\>10%). Higher CaRi-Heart Risk Score means higher risk. We reported the change in FAI Score and CaRi-Heart Risk Score from baseline here.

Outcome measures

Outcome measures
Measure
Placebo
n=19 Participants
Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes. Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months.
Active Treatment
n=31 Participants
Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes. Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months.
Change in Coronary Artery Inflammation by CCTA
FAI Score - Left Anterior Descending Artery
3.119 scores on a scale
Standard Deviation 1.7936
4.215 scores on a scale
Standard Deviation 3.0311
Change in Coronary Artery Inflammation by CCTA
FAI Score - Left Circumflex Coronary Artery
0.332 scores on a scale
Standard Deviation 1.5630
-0.808 scores on a scale
Standard Deviation 2.2185
Change in Coronary Artery Inflammation by CCTA
FAI Score - Right Coronary Artery
0.022 scores on a scale
Standard Deviation 2.5323
-2.288 scores on a scale
Standard Deviation 6.5015
Change in Coronary Artery Inflammation by CCTA
CaRi-Heart Score
0.83 scores on a scale
Standard Deviation 4.393
-2.34 scores on a scale
Standard Deviation 7.923

OTHER_PRE_SPECIFIED outcome

Timeframe: 106 days (Week 15)

Change in total, noncalcified and low attenuation coronary artery plaque volume some measurements have inter-quartile of 0 and median of 0 because most of the participants have a baseline value of 0 (no plaque at baseline) and remain no changes during the trial.

Outcome measures

Outcome measures
Measure
Placebo
n=20 Participants
Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes. Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months.
Active Treatment
n=39 Participants
Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes. Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months.
Change in Coronary Artery Plaque Burden by CCTA
Total plaque volume
1.535 cubic millimeter
Interval 0.0 to 23.955
1.160 cubic millimeter
Interval 0.0 to 5.31
Change in Coronary Artery Plaque Burden by CCTA
Low attenuation plaque volume
0 cubic millimeter
Interval 0.0 to 0.115
0 cubic millimeter
Interval 0.0 to 0.0
Change in Coronary Artery Plaque Burden by CCTA
Non-calcified plaque volume
0.320 cubic millimeter
Interval 0.0 to 10.255
0.160 cubic millimeter
Interval 0.0 to 1.28

Adverse Events

Active Treatment

Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Active Treatment
n=52 participants at risk
Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes. Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months.
Placebo
n=25 participants at risk
Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes. Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months.
Infections and infestations
Bone abscess
1.9%
1/52 • From enrollment until end of follow-up, up to 15 weeks
\[Not Specific\]
0.00%
0/25 • From enrollment until end of follow-up, up to 15 weeks
\[Not Specific\]
Gastrointestinal disorders
Constipation
1.9%
1/52 • From enrollment until end of follow-up, up to 15 weeks
\[Not Specific\]
0.00%
0/25 • From enrollment until end of follow-up, up to 15 weeks
\[Not Specific\]

Other adverse events

Other adverse events
Measure
Active Treatment
n=52 participants at risk
Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes. Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months.
Placebo
n=25 participants at risk
Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes. Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months.
Infections and infestations
Covid-19 infection
1.9%
1/52 • From enrollment until end of follow-up, up to 15 weeks
\[Not Specific\]
12.0%
3/25 • From enrollment until end of follow-up, up to 15 weeks
\[Not Specific\]
Nervous system disorders
Headache
5.8%
3/52 • From enrollment until end of follow-up, up to 15 weeks
\[Not Specific\]
8.0%
2/25 • From enrollment until end of follow-up, up to 15 weeks
\[Not Specific\]

Additional Information

Clinical Scientist

Abcentra

Phone: 4243694401

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place