Trial Outcomes & Findings for A Study of Bermekimab for the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis (NCT NCT04990440)

NCT ID: NCT04990440

Last Updated: 2023-05-24

Results Overview

Percentage of participants with EASI-75 (\>=75% improvement from Baseline in EASI score) was planned to be reported in this outcome measure. The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. The severity of the clinical signs of AD for each of 4 body regions was scored on a 4-point scale: 0=absent, 1=mild, 2=moderate and 3=severe. The area of AD involvement on each of the 4 anatomic regions was assessed as a percentage by body area: 0=no eruption, 1=1% to 9%, 2=10% to 29%, 3=30% to 49%, 4=50% to 60%, 5=70% to 80% and 6=90% to 100%. The total score is the sum of the four body-region scores ranged from 0.0 to 72.0, with higher scores reflecting greater disease severity.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 6 participants
• Primary outcome timeframe: Week 16
• Results posted on: 2023-05-24

Participant Flow

A total of 9 participants were screened, of which, only 6 participants were enrolled and randomized. Planned Part C was not performed due to premature study termination.

Participant milestones

Measure	Part A: Placebo Participants received placebo matching to bermekimab as an intravenous (IV) infusion weekly from Week 0 through Week 6.	Part A: Bermekimab 800 mg IV Participants received bermekimab 800 milligrams (mg) as an IV infusion weekly from Week 0 through Week 6.	Part B: Bermekimab 1200 mg IV Participants received bermekimab 1200 mg as an IV infusion weekly from Week 0 through Week 6.
Overall Study STARTED	1	4	1
Overall Study COMPLETED	1	4	0
Overall Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Measure	Part A: Placebo Participants received placebo matching to bermekimab as an intravenous (IV) infusion weekly from Week 0 through Week 6.	Part A: Bermekimab 800 mg IV Participants received bermekimab 800 milligrams (mg) as an IV infusion weekly from Week 0 through Week 6.	Part B: Bermekimab 1200 mg IV Participants received bermekimab 1200 mg as an IV infusion weekly from Week 0 through Week 6.
Overall Study Sponsor's Decision	0	0	1

Baseline Characteristics

A Study of Bermekimab for the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis

Baseline characteristics by cohort

Measure	Part A: Placebo n=1 Participants Participants received placebo matching to bermekimab as an intravenous (IV) infusion weekly from Week 0 through Week 6.	Part A: Bermekimab 800 mg IV n=4 Participants Participants received bermekimab 800 milligrams (mg) as an IV infusion weekly from Week 0 through Week 6.	Part B: Bermekimab 1200 mg IV n=1 Participants Participants received bermekimab 1200 mg as an IV infusion weekly from Week 0 through Week 6.	Total n=6 Participants Total of all reporting groups
Age, Continuous	19 years n=5 Participants	34.5 years STANDARD_DEVIATION 16.34 • n=7 Participants	47 years n=5 Participants	34 years STANDARD_DEVIATION 15.47 • n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment ARGENTINA	1 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Region of Enrollment UNITED STATES	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 16

Population: The full analysis set (FAS) included all participants who were randomized at Week 0 and received at least 1 dose of study intervention. Due to premature study termination, planned data collection and analysis could not be performed for this outcome measure.

Percentage of participants with EASI-75 (>=75% improvement from Baseline in EASI score) was planned to be reported in this outcome measure. The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. The severity of the clinical signs of AD for each of 4 body regions was scored on a 4-point scale: 0=absent, 1=mild, 2=moderate and 3=severe. The area of AD involvement on each of the 4 anatomic regions was assessed as a percentage by body area: 0=no eruption, 1=1% to 9%, 2=10% to 29%, 3=30% to 49%, 4=50% to 60%, 5=70% to 80% and 6=90% to 100%. The total score is the sum of the four body-region scores ranged from 0.0 to 72.0, with higher scores reflecting greater disease severity.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Week 20

Population: Pharmacokinetic (PK) analysis set included all participants who received at least one dose of bermekimab and had at least one post-dose sample collection.

Serum concentrations of bermekimab was planned to be reported up to Week 20 but due to premature study termination, planned data collection and analysis could not be performed for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Week 16

Population: Immunogenicity analysis set included all participants who received at least one dose of bermekimab and had at least one post-dose sample collection.

Number of participants with ADAs and NAbs to bermekimab was planned to be reported up to Week 16 but due to premature study termination, planned data collection and analysis could not be performed for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Week 6

Population: The safety analysis set included all participants who received at least 1 dose of study intervention and were analyzed based on the treatment they actually received regardless of the treatment groups to which they were assigned.

An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Any AE occurring at or after the initial administration of study intervention up to end of study was considered as treatment-emergent. Due to premature study termination, data collected up to Week 6 were analyzed and reported for this outcome measure.

Outcome measures

Measure	Part A: Placebo n=1 Participants Participants received placebo matching to bermekimab as an intravenous (IV) infusion weekly from Week 0 through Week 6.	Part A: Bermekimab 800 mg IV n=4 Participants Participants received bermekimab 800 milligrams (mg) as an IV infusion weekly from Week 0 through Week 6.	Part B: Bermekimab 1200 mg IV n=1 Participants Participants received bermekimab 1200 mg as an IV infusion weekly from Week 0 through Week 6.
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)	100 Percentage of participants	75 Percentage of participants	100 Percentage of participants

SECONDARY outcome

Timeframe: Up to Week 6

Population: The safety analysis set included all participants who received at least 1 dose of study intervention and were analyzed based on the treatment they actually received regardless of the treatment groups to which they were assigned.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product. Any SAEs occurring at or after the initial administration of study intervention up to end of the study was considered as treatment-emergent. Due to premature study termination, data collected up to Week 6 were analyzed and reported for this outcome measure.

Outcome measures

Measure	Part A: Placebo n=1 Participants Participants received placebo matching to bermekimab as an intravenous (IV) infusion weekly from Week 0 through Week 6.	Part A: Bermekimab 800 mg IV n=4 Participants Participants received bermekimab 800 milligrams (mg) as an IV infusion weekly from Week 0 through Week 6.	Part B: Bermekimab 1200 mg IV n=1 Participants Participants received bermekimab 1200 mg as an IV infusion weekly from Week 0 through Week 6.
Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs)	0 Percentage of participants	0 Percentage of participants	100 Percentage of participants

SECONDARY outcome

Timeframe: Up to Week 6

Population: The safety analysis set included all participants who received at least 1 dose of study intervention and were analyzed based on the treatment they actually received regardless of the treatment groups to which they were assigned.

Percentage of participants with AEs leading to discontinuation of study intervention was reported. An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Due to premature study termination, data collected up to Week 6 were analyzed and reported for this outcome measure.

Outcome measures

Measure	Part A: Placebo n=1 Participants Participants received placebo matching to bermekimab as an intravenous (IV) infusion weekly from Week 0 through Week 6.	Part A: Bermekimab 800 mg IV n=4 Participants Participants received bermekimab 800 milligrams (mg) as an IV infusion weekly from Week 0 through Week 6.	Part B: Bermekimab 1200 mg IV n=1 Participants Participants received bermekimab 1200 mg as an IV infusion weekly from Week 0 through Week 6.
Percentage of Participants With AEs Leading to Discontinuation of Study Intervention	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Up to Week 6

Population: The safety analysis set included all participants who received at least 1 dose of study intervention and were analyzed based on the treatment they actually received regardless of the treatment groups to which they were assigned.

Percentage of participants with AEs reasonably related to study intervention was reported. An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Due to premature study termination, data collected up to Week 6 were analyzed and reported for this outcome measure.

Outcome measures

Measure	Part A: Placebo n=1 Participants Participants received placebo matching to bermekimab as an intravenous (IV) infusion weekly from Week 0 through Week 6.	Part A: Bermekimab 800 mg IV n=4 Participants Participants received bermekimab 800 milligrams (mg) as an IV infusion weekly from Week 0 through Week 6.	Part B: Bermekimab 1200 mg IV n=1 Participants Participants received bermekimab 1200 mg as an IV infusion weekly from Week 0 through Week 6.
Percentage of Participants With AEs Reasonably Related to Study Intervention	0 Percentage of participants	25 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Up to Week 6

Population: The safety analysis set included all participants who received at least 1 dose of study intervention and were analyzed based on the treatment they actually received regardless of the treatment groups to which they were assigned.

Percentage of participants with adverse events of infusion-related reactions was reported. An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Due to premature study termination, data collected up to Week 6 were analyzed and reported for this outcome measure.

Outcome measures

Measure	Part A: Placebo n=1 Participants Participants received placebo matching to bermekimab as an intravenous (IV) infusion weekly from Week 0 through Week 6.	Part A: Bermekimab 800 mg IV n=4 Participants Participants received bermekimab 800 milligrams (mg) as an IV infusion weekly from Week 0 through Week 6.	Part B: Bermekimab 1200 mg IV n=1 Participants Participants received bermekimab 1200 mg as an IV infusion weekly from Week 0 through Week 6.
Percentage of Participants With Adverse Events of Infusion-related Reactions	0 Percentage of participants	25 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Up to Week 6

Population: The safety analysis set included all participants who received at least 1 dose of study intervention and were analyzed based on the treatment they actually received regardless of the treatment groups to which they were assigned.

Percentage of participants with AEs of infections (including serious infections and infections requiring oral or parenteral antimicrobial treatment) was reported. An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Due to premature study termination, data collected up to Week 6 were analyzed and reported for this outcome measure.

Outcome measures

Measure	Part A: Placebo n=1 Participants Participants received placebo matching to bermekimab as an intravenous (IV) infusion weekly from Week 0 through Week 6.	Part A: Bermekimab 800 mg IV n=4 Participants Participants received bermekimab 800 milligrams (mg) as an IV infusion weekly from Week 0 through Week 6.	Part B: Bermekimab 1200 mg IV n=1 Participants Participants received bermekimab 1200 mg as an IV infusion weekly from Week 0 through Week 6.
Percentage of Participants With AEs of Infections	0 Percentage of participants	50 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Up to Week 6

Population: The safety analysis set included all participants who received at least 1 dose of study intervention and were analyzed based on the treatment they actually received regardless of the treatment groups to which they were assigned.

In this outcome measure, percentage of participants with clinically significant abnormalities in vital sign (respiratory rate) was reported. The clinical significance was determined by the investigator. Due to premature study termination, data collected up to Week 6 were analyzed and reported for this outcome measure.

Outcome measures

Measure	Part A: Placebo n=1 Participants Participants received placebo matching to bermekimab as an intravenous (IV) infusion weekly from Week 0 through Week 6.	Part A: Bermekimab 800 mg IV n=4 Participants Participants received bermekimab 800 milligrams (mg) as an IV infusion weekly from Week 0 through Week 6.	Part B: Bermekimab 1200 mg IV n=1 Participants Participants received bermekimab 1200 mg as an IV infusion weekly from Week 0 through Week 6.
Percentage of Participants With Clinically Significant Abnormalities in Vital Signs	100 Percentage of participants	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Up to Week 6

Population: The safety analysis set included all participants who received at least 1 dose of study intervention and were analyzed based on the treatment they actually received regardless of the treatment groups to which they were assigned.

In this outcome measure, percentage of participants with >=2 National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade in laboratory parameter 'clinical chemistry-potassium (normal range: 3.5 to 5.2 mmol/L)' was reported. Grading was done as: Grade 1 (=mild), Grade 2 (=moderate), Grade 3 (=severe) and Grade 4 (=potentially life-threatening). The clinical significance was determined by the investigator. Due to premature study termination, data collected up to Week 6 were analyzed and reported for this outcome measure.

Outcome measures

Measure	Part A: Placebo n=1 Participants Participants received placebo matching to bermekimab as an intravenous (IV) infusion weekly from Week 0 through Week 6.	Part A: Bermekimab 800 mg IV n=4 Participants Participants received bermekimab 800 milligrams (mg) as an IV infusion weekly from Week 0 through Week 6.	Part B: Bermekimab 1200 mg IV n=1 Participants Participants received bermekimab 1200 mg as an IV infusion weekly from Week 0 through Week 6.
Percentage of Participants With Clinically Significant Abnormalities in Laboratory Tests	0 Percentage of participants	25 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Week 16

Population: FAS included all participants who were randomized at Week 0 and received at least 1 dose of study intervention. Due to premature study termination, planned data collection and analysis could not be performed for this outcome measure.

Percentage of participants with both vIGA-AD score of 0 or 1 and a reduction from baseline of >=2 points was reported. IGA was an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale ranged from 0 to 4, where 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe. Higher scores indicated greater severity. The IGA score was selected using the morphological descriptors that best described the overall appearance (erythema and population/infiltration) of the AD lesions at a given time point.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 16

Population: FAS included all participants who were randomized at Week 0 and received at least 1 dose of study intervention. Due to premature study termination, planned data collection and analysis could not be performed for this outcome measure.

Percentage of participants with improvement (reduction) of eczema-related itch NRS score of >=4 from baseline among participants with a baseline itch value >=4 was reported in this outcome measure. The eczema skin pain and itch NRS was a 2-item (pain and itch) patient-reported outcome (PRO) developed by the sponsor that participants used to rate the severity of their eczema-related skin pain and itch daily. To rate the severity of eczema-related itch, participants were asked the following question: 'how would you rate your itch at the worst moment during the previous 24 hours' and the response was scored on a scale of 0 (no itch) to 10 (worst itch imaginable).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 16

Population: FAS included all participants who were randomized at Week 0 and received at least 1 dose of study intervention. Due to premature study termination, planned data collection and analysis could not be performed for this outcome measure.

Percentage of participants with EASI-90 was planned to be reported. The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. The severity of the clinical signs of AD for each of 4 body regions was scored on a 4-point scale: 0=absent, 1=mild, 2=moderate and 3=severe. The area of AD involvement on each of the 4 anatomic regions was assessed as a percentage by body area: 0=no eruption, 1=1% to 9%, 2=10% to 29%, 3=30% to 49%, 4=50% to 60%, 5=70% to 80% and 6=90% to 100%. The total score is the sum of the four body-region scores ranged from 0.0 to 72.0, with higher scores reflecting greater disease severity.

Outcome measures

Outcome data not reported

Adverse Events

Part A: Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part A: Bermekimab 800 mg IV

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part B: Bermekimab 1200 mg IV

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Part A: Placebo n=1 participants at risk Participants received placebo matching to bermekimab as an intravenous (IV) infusion weekly from Week 0 through Week 6.	Part A: Bermekimab 800 mg IV n=4 participants at risk Participants received bermekimab 800 milligrams (mg) as an IV infusion weekly from Week 0 through Week 6.	Part B: Bermekimab 1200 mg IV n=1 participants at risk Participants received bermekimab 1200 mg as an IV infusion weekly from Week 0 through Week 6.
Injury, poisoning and procedural complications Accidental Overdose	0.00% 0/1 • Up to Week 6 The safety analysis set included all participants who received at least 1 dose of study intervention and were analyzed based on the treatment they actually received regardless of the treatment groups to which they were assigned. Due to premature study termination, adverse events data collected up to Week 6 were analyzed and reported in this section.	0.00% 0/4 • Up to Week 6 The safety analysis set included all participants who received at least 1 dose of study intervention and were analyzed based on the treatment they actually received regardless of the treatment groups to which they were assigned. Due to premature study termination, adverse events data collected up to Week 6 were analyzed and reported in this section.	100.0% 1/1 • Up to Week 6 The safety analysis set included all participants who received at least 1 dose of study intervention and were analyzed based on the treatment they actually received regardless of the treatment groups to which they were assigned. Due to premature study termination, adverse events data collected up to Week 6 were analyzed and reported in this section.

Other adverse events

Measure	Part A: Placebo n=1 participants at risk Participants received placebo matching to bermekimab as an intravenous (IV) infusion weekly from Week 0 through Week 6.	Part A: Bermekimab 800 mg IV n=4 participants at risk Participants received bermekimab 800 milligrams (mg) as an IV infusion weekly from Week 0 through Week 6.	Part B: Bermekimab 1200 mg IV n=1 participants at risk Participants received bermekimab 1200 mg as an IV infusion weekly from Week 0 through Week 6.
Infections and infestations Otitis Externa	0.00% 0/1 • Up to Week 6 The safety analysis set included all participants who received at least 1 dose of study intervention and were analyzed based on the treatment they actually received regardless of the treatment groups to which they were assigned. Due to premature study termination, adverse events data collected up to Week 6 were analyzed and reported in this section.	25.0% 1/4 • Up to Week 6 The safety analysis set included all participants who received at least 1 dose of study intervention and were analyzed based on the treatment they actually received regardless of the treatment groups to which they were assigned. Due to premature study termination, adverse events data collected up to Week 6 were analyzed and reported in this section.	0.00% 0/1 • Up to Week 6 The safety analysis set included all participants who received at least 1 dose of study intervention and were analyzed based on the treatment they actually received regardless of the treatment groups to which they were assigned. Due to premature study termination, adverse events data collected up to Week 6 were analyzed and reported in this section.
Infections and infestations Vulvovaginal Candidiasis	0.00% 0/1 • Up to Week 6 The safety analysis set included all participants who received at least 1 dose of study intervention and were analyzed based on the treatment they actually received regardless of the treatment groups to which they were assigned. Due to premature study termination, adverse events data collected up to Week 6 were analyzed and reported in this section.	25.0% 1/4 • Up to Week 6 The safety analysis set included all participants who received at least 1 dose of study intervention and were analyzed based on the treatment they actually received regardless of the treatment groups to which they were assigned. Due to premature study termination, adverse events data collected up to Week 6 were analyzed and reported in this section.	0.00% 0/1 • Up to Week 6 The safety analysis set included all participants who received at least 1 dose of study intervention and were analyzed based on the treatment they actually received regardless of the treatment groups to which they were assigned. Due to premature study termination, adverse events data collected up to Week 6 were analyzed and reported in this section.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/1 • Up to Week 6 The safety analysis set included all participants who received at least 1 dose of study intervention and were analyzed based on the treatment they actually received regardless of the treatment groups to which they were assigned. Due to premature study termination, adverse events data collected up to Week 6 were analyzed and reported in this section.	25.0% 1/4 • Up to Week 6 The safety analysis set included all participants who received at least 1 dose of study intervention and were analyzed based on the treatment they actually received regardless of the treatment groups to which they were assigned. Due to premature study termination, adverse events data collected up to Week 6 were analyzed and reported in this section.	0.00% 0/1 • Up to Week 6 The safety analysis set included all participants who received at least 1 dose of study intervention and were analyzed based on the treatment they actually received regardless of the treatment groups to which they were assigned. Due to premature study termination, adverse events data collected up to Week 6 were analyzed and reported in this section.
Skin and subcutaneous tissue disorders Dermatitis Atopic	100.0% 1/1 • Up to Week 6 The safety analysis set included all participants who received at least 1 dose of study intervention and were analyzed based on the treatment they actually received regardless of the treatment groups to which they were assigned. Due to premature study termination, adverse events data collected up to Week 6 were analyzed and reported in this section.	50.0% 2/4 • Up to Week 6 The safety analysis set included all participants who received at least 1 dose of study intervention and were analyzed based on the treatment they actually received regardless of the treatment groups to which they were assigned. Due to premature study termination, adverse events data collected up to Week 6 were analyzed and reported in this section.	0.00% 0/1 • Up to Week 6 The safety analysis set included all participants who received at least 1 dose of study intervention and were analyzed based on the treatment they actually received regardless of the treatment groups to which they were assigned. Due to premature study termination, adverse events data collected up to Week 6 were analyzed and reported in this section.

Additional Information

Director Clinical Research Dermatology

Janssen Research & Development, LLC

Phone: 844-434-4210

Email: ClinicalTrialDisclosure@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
• Publication restrictions are in place

Restriction type: OTHER