Trial Outcomes & Findings for A Study to Evaluate Safety and Effectiveness of Cendakimab (CC-93538) in Participants With Moderate to Severe Atopic Dermatitis (NCT NCT04800315)

Results Overview

The Eczema Area and Severity Index (EASI) is a composite scoring system assessed by the Investigator based on the proportion of each of the 4 body regions (head and neck, upper limbs, lower limbs, and trunk) affected with Atopic Dermatitis (AD) and the intensity of each of 4 main signs of AD (eg, erythema, induration/papulation, excoriation, and lichenification) and is based on a 4-point scale of 0 (none), 1 (mild), 2 (moderate), and 3 (severe). The sum of the scores is totaled (0 to 72), the lower the score the better.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

221 participants

Primary outcome timeframe

From initial EASI measurement to week 16

Results posted on

2024-01-03

Participant Flow

221 participants Randomized, 220 Participants Treated

Participant milestones

Participant milestones
Measure	Treatment 1 CC-93538 High Dose QW	Treatment 2 CC-93538 High Dose Q2W	Treatment 3 CC-93538 Low Dose Q2W	Placebo Placebo
Randomization STARTED	55	55	55	56
Randomization COMPLETED	54	55	55	56
Randomization NOT COMPLETED	1	0	0	0
Treatment Period STARTED	54	55	55	56
Treatment Period COMPLETED	49	50	52	44
Treatment Period NOT COMPLETED	5	5	3	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment 1 CC-93538 High Dose QW	Treatment 2 CC-93538 High Dose Q2W	Treatment 3 CC-93538 Low Dose Q2W	Placebo Placebo
Randomization Did not receive study treatment	1	0	0	0
Treatment Period Adverse Event	4	2	1	2
Treatment Period Lack of Efficacy	1	0	0	3
Treatment Period Lost to Follow-up	0	1	2	2
Treatment Period Withdrawal by participant	0	0	0	4
Treatment Period Other Reasons	0	2	0	1

Baseline Characteristics

A Study to Evaluate Safety and Effectiveness of Cendakimab (CC-93538) in Participants With Moderate to Severe Atopic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment 1 n=55 Participants CC-93538 High Dose QW	Treatment 2 n=55 Participants CC-93538 High Dose Q2W	Treatment 3 n=55 Participants CC-93538 Low Dose Q2W	Placebo n=56 Participants Placebo	Total n=221 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Age, Categorical Between 18 and 65 years	53 Participants n=99 Participants	52 Participants n=107 Participants	51 Participants n=206 Participants	53 Participants n=7 Participants	209 Participants n=31 Participants
Age, Categorical >=65 years	2 Participants n=99 Participants	3 Participants n=107 Participants	4 Participants n=206 Participants	3 Participants n=7 Participants	12 Participants n=31 Participants
Sex: Female, Male Female	19 Participants n=99 Participants	26 Participants n=107 Participants	29 Participants n=206 Participants	21 Participants n=7 Participants	95 Participants n=31 Participants
Sex: Female, Male Male	36 Participants n=99 Participants	29 Participants n=107 Participants	26 Participants n=206 Participants	35 Participants n=7 Participants	126 Participants n=31 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=99 Participants	2 Participants n=107 Participants	0 Participants n=206 Participants	3 Participants n=7 Participants	6 Participants n=31 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	53 Participants n=99 Participants	53 Participants n=107 Participants	55 Participants n=206 Participants	53 Participants n=7 Participants	214 Participants n=31 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	1 Participants n=31 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	1 Participants n=31 Participants
Race (NIH/OMB) Asian	19 Participants n=99 Participants	14 Participants n=107 Participants	14 Participants n=206 Participants	13 Participants n=7 Participants	60 Participants n=31 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Black or African American	4 Participants n=99 Participants	8 Participants n=107 Participants	5 Participants n=206 Participants	6 Participants n=7 Participants	23 Participants n=31 Participants
Race (NIH/OMB) White	30 Participants n=99 Participants	33 Participants n=107 Participants	36 Participants n=206 Participants	37 Participants n=7 Participants	136 Participants n=31 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	1 Participants n=31 Participants
modified Intent to treat population (mITT)	54 Participants n=99 Participants	55 Participants n=107 Participants	55 Participants n=206 Participants	56 Participants n=7 Participants	220 Participants n=31 Participants

PRIMARY outcome

Timeframe: From initial EASI measurement to week 16

Population: Modified Intent to Treat (mITT) Population

The Eczema Area and Severity Index (EASI) is a composite scoring system assessed by the Investigator based on the proportion of each of the 4 body regions (head and neck, upper limbs, lower limbs, and trunk) affected with Atopic Dermatitis (AD) and the intensity of each of 4 main signs of AD (eg, erythema, induration/papulation, excoriation, and lichenification) and is based on a 4-point scale of 0 (none), 1 (mild), 2 (moderate), and 3 (severe). The sum of the scores is totaled (0 to 72), the lower the score the better.

Outcome measures

Outcome measures
Measure	Treatment 1 n=54 Participants CC-93538 High Dose QW	Treatment 2 n=55 Participants CC-93538 High Dose Q2W	Treatment 3 n=55 Participants CC-93538 Low Dose Q2W	Placebo n=56 Participants Placebo
Mean Percentage Change From Baseline in EASI at Week 16	-84.41 Percent Change Standard Error 5.07	-76.03 Percent Change Standard Error 4.20	-78.93 Percent Change Standard Error 4.53	-62.65 Percent Change Standard Error 5.53

SECONDARY outcome

Timeframe: From initial vIGA-AD assessment to week 16

Population: Modified Intent to Treat (mITT) Population

The Validated Investigator Global Assessment (vIGA-AD) is a validated 5-point assessment intended to assess the global severities of key acute clinical signs of AD, including erythema, induration/papulation, oozing/crusting (lichenification excluded). The rating of clear (0), almost clear (1), mild (2), moderate (3) and severe (4), will be assessed at scheduled visits. The vIGA-AD must be conducted before the EASI assessment. The vIGA-AD is a static evaluation conducted without regard to the score obtained at a previous visit. Percentage of responders calculated using Multiple Imputation (MI) approach. For participants discontinued study drug, whose vIGA-AD response at Week 16 are missing or cannot be adequately determined (including missing due to COVID-19) without use of rescue therapy/prohibited medication prior to Week 16, their outcomes will be handled using a MI approach assuming missing at random (MAR).

Outcome measures

Outcome measures
Measure	Treatment 1 n=54 Participants CC-93538 High Dose QW	Treatment 2 n=55 Participants CC-93538 High Dose Q2W	Treatment 3 n=55 Participants CC-93538 Low Dose Q2W	Placebo n=56 Participants Placebo
Percentage of Responders With an vIGA-AD Score of 0 (Clear) or 1 (Almost Clear) and a Reduction ≥ 2 Points From Baseline at Week 16	33.3 Percentage of Participants	24.4 Percentage of Participants	38.2 Percentage of Participants	9.4 Percentage of Participants

SECONDARY outcome

Timeframe: From initial EASI measurement to week 16

Population: modified Intent to Treat (mITT) population

The EASI is a composite scoring system assessed by the Investigator based on the proportion of each of the 4 body regions (head and neck, upper limbs, lower limbs, and trunk) affected with AD and the intensity of each of 4 main signs of AD (eg, erythema, induration/papulation, excoriation, and lichenification) and is based on a 4-point scale of 0 (none), 1 (mild), 2 (moderate), and 3 (severe). The sum of the scores is totaled (0 to 72), the lower the score the better. Percentage of responders calculated using Multiple Imputation (MI) approach. For participants discontinued study drug, whose EASI-75 response at Week 16 are missing or cannot be adequately determined (including missing due to COVID-19) without use of rescue therapy/prohibited medication prior to Week 16, their outcomes will be handled using a MI approach assuming missing at random (MAR).

Outcome measures

Outcome measures
Measure	Treatment 1 n=54 Participants CC-93538 High Dose QW	Treatment 2 n=55 Participants CC-93538 High Dose Q2W	Treatment 3 n=55 Participants CC-93538 Low Dose Q2W	Placebo n=56 Participants Placebo
Percentage of EASI-75 Responders at Week 16	50.0 Percentage of Participants	48.2 Percentage of Participants	52.7 Percentage of Participants	26.3 Percentage of Participants

SECONDARY outcome

Timeframe: From initial EASI measurement to week 16

Population: Modified Intent to Treat (mITT) Population

The Eczema Area and Severity Index (EASI) is a composite scoring system assessed by the Investigator based on the proportion of each of the 4 body regions (head and neck, upper limbs, lower limbs, and trunk) affected with Atopic Dermatitis (AD) and the intensity of each of 4 main signs of AD (eg, erythema, induration/papulation, excoriation, and lichenification) and is based on a 4-point scale of 0 (none), 1 (mild), 2 (moderate), and 3 (severe). The sum of the scores is totaled (0 to 72), the lower the score the better. Percentage of responders calculated using Multiple Imputation (MI) approach. For participants discontinued study drug, whose EASI-90 response at Week 16 are missing or cannot be adequately determined (including missing due to COVID-19) without use of rescue therapy/prohibited medication prior to Week 16, their outcomes will be handled using a MI approach assuming missing at random (MAR).

Outcome measures

Outcome measures
Measure	Treatment 1 n=54 Participants CC-93538 High Dose QW	Treatment 2 n=55 Participants CC-93538 High Dose Q2W	Treatment 3 n=55 Participants CC-93538 Low Dose Q2W	Placebo n=56 Participants Placebo
Percentage of EASI-90 Responders at Week 16	31.5 Percentage of participants	24.0 Percentage of participants	29.1 Percentage of participants	13.4 Percentage of participants

SECONDARY outcome

Timeframe: From initial SCORAD measurement to week 16

Population: Modified Intent to Treat (mITT) population

The SCORAD is a validated scoring index for atopic dermatitis, which combines extent (0 to 100), severity (0 to 18), and subjective symptoms (0 to 20) based on pruritus and sleep loss, each scored (0 to 10). The subject will assess the subjective symptoms (itch and sleepless) part of the assessment. SCORing Atopic Dermatitis Index (SCORAD) score ranges from 0 to 103, higher scores indicate more severe disease.

Outcome measures

Outcome measures
Measure	Treatment 1 n=54 Participants CC-93538 High Dose QW	Treatment 2 n=55 Participants CC-93538 High Dose Q2W	Treatment 3 n=55 Participants CC-93538 Low Dose Q2W	Placebo n=56 Participants Placebo
Percent Change in Mean SCORAD Scores From Baseline at Week 16	-69.28 Percent Change Standard Error 4.64	-55.47 Percent Change Standard Error 4.08	-60.19 Percent Change Standard Error 4.38	-41.11 Percent Change Standard Error 5.61

SECONDARY outcome

Timeframe: From initial NRS measurement to week 16

Population: Modified Intent to Treat (mITT) population

Pruritus will be assessed by the subject using the Pruritus NRS, which was developed and validated as a single item, patient reported outcome (PRO) of itch severity. Clinical response is indicated by a ≥ 2 to 4-point change from baseline in Peak Pruritus NRS score. The intensity of pruritus will be assessed based on last 24 hours using a validated 11-point NRS, ranging from 0 ("no pruritus") to 10 ("the worst pruritus imaginable").

Outcome measures

Outcome measures
Measure	Treatment 1 n=54 Participants CC-93538 High Dose QW	Treatment 2 n=55 Participants CC-93538 High Dose Q2W	Treatment 3 n=55 Participants CC-93538 Low Dose Q2W	Placebo n=56 Participants Placebo
Percent Change From Baseline in Pruritus NRS at Week 16	-55.48 Percent Change Standard Error 6.22	-46.15 Percent Change Standard Error 5.32	-49.30 Percent Change Standard Error 5.89	-32.98 Percent Change Standard Error 7.46

SECONDARY outcome

Timeframe: From initial NRS assessment to week 16

Population: Modified Intent to Treat (mITT) Population

Pruritus will be assessed by the subject using the Pruritus NRS, which was developed and validated as a single item, patient reported outcome (PRO) of itch severity. Clinical response is indicated by a ≥ 2 to 4-point change from baseline in Peak Pruritus NRS score. The intensity of pruritus will be assessed based on last 24 hours using a validated 11-point NRS, ranging from 0 ("no pruritus") to 10 ("the worst pruritus imaginable"). Percentage of responders calculated using Multiple Imputation (MI) approach. For participants discontinued study drug, whose pruritus NRS response at Week 16 are missing or cannot be adequately determined (including missing due to COVID-19) without use of rescue therapy/prohibited medication prior to Week 16, their outcomes will be handled using a MI approach assuming missing at random (MAR).

Outcome measures

Outcome measures
Measure	Treatment 1 n=54 Participants CC-93538 High Dose QW	Treatment 2 n=55 Participants CC-93538 High Dose Q2W	Treatment 3 n=55 Participants CC-93538 Low Dose Q2W	Placebo n=56 Participants Placebo
Percentage of Participants With a Response and Pruritus NRS Change of ≥ 4 Points From Baseline at Week 16	33.3 Percentage of Participants	34.5 Percentage of Participants	32.7 Percentage of Participants	14.8 Percentage of Participants

SECONDARY outcome

Timeframe: From initial NRS pruritus response up to study day 127 (127 days)

Population: Modified Intent to Treat (mITT) Population

Pruritus will be assessed by the subject using the Pruritus NRS, which was developed and validated as a single item, patient reported outcome (PRO) of itch severity. Clinical response is indicated by a ≥ 2 to 4-point change from baseline in Peak Pruritus NRS score. The intensity of pruritus will be assessed based on last 24 hours using a validated 11-point NRS, ranging from 0 ("no pruritus") to 10 ("the worst pruritus imaginable").

Outcome measures

Outcome measures
Measure	Treatment 1 n=54 Participants CC-93538 High Dose QW	Treatment 2 n=55 Participants CC-93538 High Dose Q2W	Treatment 3 n=55 Participants CC-93538 Low Dose Q2W	Placebo n=56 Participants Placebo
Time to Achieve at Least 4 Points of Improvement in the Severity of Pruritus NRS Scale.	54.0 Days Interval 28.0 to 93.0	76.0 Days Interval 42.0 to 105.0	50.0 Days Interval 27.0 to 111.0	123.0 Days Interval 119.0 to Not enough events to derive upper limit number via Kaplan-Meier estimates

SECONDARY outcome

Timeframe: From initial BSA assessment to week 16

Population: Modified Intent to Treat (mITT) Population

Body Surface Area involvement will be calculated from the sum of the number of handprints of skin afflicted with atopic dermatitis in a body region. The number of handprints of skin afflicted with atopic dermatitis in a body region can be used to determine the extent (%) to which a body region is involved with AD. When measuring, the handprint unit refers to the size of each individual subject's hand with fingers in a closed position. BSA will be calculated by the Investigator or qualified designee using the 1% handprint rule, in which the area represented by the palm with all 5 digits adducted together is approximately 1% of the subject's BSA.

Outcome measures

Outcome measures
Measure	Treatment 1 n=54 Participants CC-93538 High Dose QW	Treatment 2 n=55 Participants CC-93538 High Dose Q2W	Treatment 3 n=55 Participants CC-93538 Low Dose Q2W	Placebo n=56 Participants Placebo
Adjust Mean Percentage Change in BSA in Atopic Dermatitis From Baseline at Week 16	-78.85 mean percentage Standard Error 6.13	-64.01 mean percentage Standard Error 5.30	-66.60 mean percentage Standard Error 6.03	-55.73 mean percentage Standard Error 6.90

SECONDARY outcome

Timeframe: From first treatment to the end of follow up, approximately 32 weeks

Population: Modified Intent to Treat (mITT) Population

Treatment emergent adverse events

Outcome measures

Outcome measures
Measure	Treatment 1 n=54 Participants CC-93538 High Dose QW	Treatment 2 n=55 Participants CC-93538 High Dose Q2W	Treatment 3 n=55 Participants CC-93538 Low Dose Q2W	Placebo n=56 Participants Placebo
Number of Participants With Treatment Emergent Adverse Events Any TEAE leading to discontinuation	4 Participants	2 Participants	1 Participants	2 Participants
Number of Participants With Treatment Emergent Adverse Events Any TEAE	40 Participants	41 Participants	38 Participants	41 Participants
Number of Participants With Treatment Emergent Adverse Events Any TEAE of special interest	9 Participants	10 Participants	8 Participants	10 Participants
Number of Participants With Treatment Emergent Adverse Events Any TESAE	2 Participants	1 Participants	2 Participants	4 Participants

SECONDARY outcome

Timeframe: From first treatment to the end of follow up, approximately 32 weeks

Population: Modified Intent to Treat (mITT) Population

Outcome measures

Outcome measures
Measure	Treatment 1 n=54 Participants CC-93538 High Dose QW	Treatment 2 n=55 Participants CC-93538 High Dose Q2W	Treatment 3 n=55 Participants CC-93538 Low Dose Q2W	Placebo Placebo
Number of Participants With the Presence of Serum Antibodies to CC-93538 Baseline ADA Positive	0 Participants	3 Participants	1 Participants	—
Number of Participants With the Presence of Serum Antibodies to CC-93538 Post Baseline Positive	22 Participants	35 Participants	28 Participants	—
Number of Participants With the Presence of Serum Antibodies to CC-93538 Post Baseline Negative	32 Participants	20 Participants	27 Participants	—

SECONDARY outcome

Timeframe: At week 16

Population: Pharmacokinetic Population

A serum trough concentration (Ctrough) is the concentration reached by a drug immediately before the next dose is administered. Serum trough concentrations (Ctrough) of CC-93538 will be summarized with descriptive statistics by treatment and visit.

Outcome measures

Outcome measures
Measure	Treatment 1 n=54 Participants CC-93538 High Dose QW	Treatment 2 n=55 Participants CC-93538 High Dose Q2W	Treatment 3 n=55 Participants CC-93538 Low Dose Q2W	Placebo Placebo
Serum Trough Concentration at Week 16 Week 16	274180.6 ng/mL Geometric Coefficient of Variation 88.0	140413.6 ng/mL Geometric Coefficient of Variation 44.0	57046.4 ng/mL Geometric Coefficient of Variation 106.8	—
Serum Trough Concentration at Week 16 Week 1	66107.2 ng/mL Geometric Coefficient of Variation 31.5	—	—	—
Serum Trough Concentration at Week 16 Week 2	120157.8 ng/mL Geometric Coefficient of Variation 29.8	54957.8 ng/mL Geometric Coefficient of Variation 38.2	26651.4 ng/mL Geometric Coefficient of Variation 35.3	—
Serum Trough Concentration at Week 16 Week 4	192521.4 ng/mL Geometric Coefficient of Variation 32.8	92827.7 ng/mL Geometric Coefficient of Variation 37.6	40802.8 ng/mL Geometric Coefficient of Variation 69.8	—
Serum Trough Concentration at Week 16 Week 6	220561.6 ng/mL Geometric Coefficient of Variation 55.2	108474.6 ng/mL Geometric Coefficient of Variation 48.3	43613.1 ng/mL Geometric Coefficient of Variation 99.7	—
Serum Trough Concentration at Week 16 Week 8	253107.2 ng/mL Geometric Coefficient of Variation 56.7	121185.1 ng/mL Geometric Coefficient of Variation 45.9	54975.0 ng/mL Geometric Coefficient of Variation 45.5	—
Serum Trough Concentration at Week 16 Week 10	279538.4 ng/mL Geometric Coefficient of Variation 34.9	136972.4 ng/mL Geometric Coefficient of Variation 35.6	60839.6 ng/mL Geometric Coefficient of Variation 43.6	—
Serum Trough Concentration at Week 16 Week 12	310649.1 ng/mL Geometric Coefficient of Variation 36.1	137656.3 ng/mL Geometric Coefficient of Variation 40.5	57197.5 ng/mL Geometric Coefficient of Variation 104.2	—
Serum Trough Concentration at Week 16 Week 14	266531.3 ng/mL Geometric Coefficient of Variation 102.3	128517.9 ng/mL Geometric Coefficient of Variation 79.4	67212.2 ng/mL Geometric Coefficient of Variation 38.9	—

SECONDARY outcome

Timeframe: From first treatment to the end of follow up, approximately 32 weeks

Population: Modified Intent to Treat Population (mITT)

Outcome measures

Outcome measures
Measure	Treatment 1 n=54 Participants CC-93538 High Dose QW	Treatment 2 n=55 Participants CC-93538 High Dose Q2W	Treatment 3 n=55 Participants CC-93538 Low Dose Q2W	Placebo n=56 Participants Placebo
Number of Participants With Clinically Significant Laboratory Abnormalities	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Treatment 1

Serious events: 2 serious events

Other events: 34 other events

Deaths: 0 deaths

Treatment 2

Serious events: 1 serious events

Other events: 35 other events

Deaths: 0 deaths

Treatment 3

Serious events: 2 serious events

Other events: 29 other events

Deaths: 0 deaths

Placebo

Serious events: 4 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment 1 n=54 participants at risk CC-93538 High Dose QW	Treatment 2 n=55 participants at risk CC-93538 High Dose Q2W	Treatment 3 n=55 participants at risk CC-93538 Low Dose Q2W	Placebo n=56 participants at risk Placebo
Gastrointestinal disorders Large intestine polyp	0.00% 0/54 • Adverse Events and Serious Adverse Events (From first treatment to end of study): Approximately 32 Weeks All-Cause mortality (From 1st dose of study to end of study): Approximately 33 Weeks The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/55 • Adverse Events and Serious Adverse Events (From first treatment to end of study): Approximately 32 Weeks All-Cause mortality (From 1st dose of study to end of study): Approximately 33 Weeks The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/55 • Adverse Events and Serious Adverse Events (From first treatment to end of study): Approximately 32 Weeks All-Cause mortality (From 1st dose of study to end of study): Approximately 33 Weeks The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/56 • Adverse Events and Serious Adverse Events (From first treatment to end of study): Approximately 32 Weeks All-Cause mortality (From 1st dose of study to end of study): Approximately 33 Weeks The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations COVID-19	0.00% 0/54 • Adverse Events and Serious Adverse Events (From first treatment to end of study): Approximately 32 Weeks All-Cause mortality (From 1st dose of study to end of study): Approximately 33 Weeks The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/55 • Adverse Events and Serious Adverse Events (From first treatment to end of study): Approximately 32 Weeks All-Cause mortality (From 1st dose of study to end of study): Approximately 33 Weeks The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/55 • Adverse Events and Serious Adverse Events (From first treatment to end of study): Approximately 32 Weeks All-Cause mortality (From 1st dose of study to end of study): Approximately 33 Weeks The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/56 • Adverse Events and Serious Adverse Events (From first treatment to end of study): Approximately 32 Weeks All-Cause mortality (From 1st dose of study to end of study): Approximately 33 Weeks The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Cellulitis	1.9% 1/54 • Adverse Events and Serious Adverse Events (From first treatment to end of study): Approximately 32 Weeks All-Cause mortality (From 1st dose of study to end of study): Approximately 33 Weeks The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/55 • Adverse Events and Serious Adverse Events (From first treatment to end of study): Approximately 32 Weeks All-Cause mortality (From 1st dose of study to end of study): Approximately 33 Weeks The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/55 • Adverse Events and Serious Adverse Events (From first treatment to end of study): Approximately 32 Weeks All-Cause mortality (From 1st dose of study to end of study): Approximately 33 Weeks The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/56 • Adverse Events and Serious Adverse Events (From first treatment to end of study): Approximately 32 Weeks All-Cause mortality (From 1st dose of study to end of study): Approximately 33 Weeks The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/54 • Adverse Events and Serious Adverse Events (From first treatment to end of study): Approximately 32 Weeks All-Cause mortality (From 1st dose of study to end of study): Approximately 33 Weeks The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/55 • Adverse Events and Serious Adverse Events (From first treatment to end of study): Approximately 32 Weeks All-Cause mortality (From 1st dose of study to end of study): Approximately 33 Weeks The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/55 • Adverse Events and Serious Adverse Events (From first treatment to end of study): Approximately 32 Weeks All-Cause mortality (From 1st dose of study to end of study): Approximately 33 Weeks The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/56 • Adverse Events and Serious Adverse Events (From first treatment to end of study): Approximately 32 Weeks All-Cause mortality (From 1st dose of study to end of study): Approximately 33 Weeks The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Product Issues Device dislocation	0.00% 0/54 • Adverse Events and Serious Adverse Events (From first treatment to end of study): Approximately 32 Weeks All-Cause mortality (From 1st dose of study to end of study): Approximately 33 Weeks The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/55 • Adverse Events and Serious Adverse Events (From first treatment to end of study): Approximately 32 Weeks All-Cause mortality (From 1st dose of study to end of study): Approximately 33 Weeks The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/55 • Adverse Events and Serious Adverse Events (From first treatment to end of study): Approximately 32 Weeks All-Cause mortality (From 1st dose of study to end of study): Approximately 33 Weeks The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/56 • Adverse Events and Serious Adverse Events (From first treatment to end of study): Approximately 32 Weeks All-Cause mortality (From 1st dose of study to end of study): Approximately 33 Weeks The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Psychiatric disorders Mental status changes	0.00% 0/54 • Adverse Events and Serious Adverse Events (From first treatment to end of study): Approximately 32 Weeks All-Cause mortality (From 1st dose of study to end of study): Approximately 33 Weeks The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/55 • Adverse Events and Serious Adverse Events (From first treatment to end of study): Approximately 32 Weeks All-Cause mortality (From 1st dose of study to end of study): Approximately 33 Weeks The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/55 • Adverse Events and Serious Adverse Events (From first treatment to end of study): Approximately 32 Weeks All-Cause mortality (From 1st dose of study to end of study): Approximately 33 Weeks The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/56 • Adverse Events and Serious Adverse Events (From first treatment to end of study): Approximately 32 Weeks All-Cause mortality (From 1st dose of study to end of study): Approximately 33 Weeks The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	1.9% 1/54 • Adverse Events and Serious Adverse Events (From first treatment to end of study): Approximately 32 Weeks All-Cause mortality (From 1st dose of study to end of study): Approximately 33 Weeks The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/55 • Adverse Events and Serious Adverse Events (From first treatment to end of study): Approximately 32 Weeks All-Cause mortality (From 1st dose of study to end of study): Approximately 33 Weeks The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/55 • Adverse Events and Serious Adverse Events (From first treatment to end of study): Approximately 32 Weeks All-Cause mortality (From 1st dose of study to end of study): Approximately 33 Weeks The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/56 • Adverse Events and Serious Adverse Events (From first treatment to end of study): Approximately 32 Weeks All-Cause mortality (From 1st dose of study to end of study): Approximately 33 Weeks The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/54 • Adverse Events and Serious Adverse Events (From first treatment to end of study): Approximately 32 Weeks All-Cause mortality (From 1st dose of study to end of study): Approximately 33 Weeks The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/55 • Adverse Events and Serious Adverse Events (From first treatment to end of study): Approximately 32 Weeks All-Cause mortality (From 1st dose of study to end of study): Approximately 33 Weeks The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/55 • Adverse Events and Serious Adverse Events (From first treatment to end of study): Approximately 32 Weeks All-Cause mortality (From 1st dose of study to end of study): Approximately 33 Weeks The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/56 • Adverse Events and Serious Adverse Events (From first treatment to end of study): Approximately 32 Weeks All-Cause mortality (From 1st dose of study to end of study): Approximately 33 Weeks The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders Deep vein thrombosis	1.9% 1/54 • Adverse Events and Serious Adverse Events (From first treatment to end of study): Approximately 32 Weeks All-Cause mortality (From 1st dose of study to end of study): Approximately 33 Weeks The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/55 • Adverse Events and Serious Adverse Events (From first treatment to end of study): Approximately 32 Weeks All-Cause mortality (From 1st dose of study to end of study): Approximately 33 Weeks The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/55 • Adverse Events and Serious Adverse Events (From first treatment to end of study): Approximately 32 Weeks All-Cause mortality (From 1st dose of study to end of study): Approximately 33 Weeks The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/56 • Adverse Events and Serious Adverse Events (From first treatment to end of study): Approximately 32 Weeks All-Cause mortality (From 1st dose of study to end of study): Approximately 33 Weeks The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication

Other adverse events

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please Email

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60