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

• Sponsor: Janssen Research & Development, LLC (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT04990440
• Collaborator: (none)
• Enrollment: 6
• Locations: 11
• Arms: 3
• Actual Duration (Months): 6.2
• Patients Per Site: 0.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy of Bermekimab, compared with placebo, in participants with moderate-to-severe atopic dermatitis (AD).

Condition or Disease	Intervention/Treatment	Phase
Dermatitis, Atopic	Drug: Bermekimab; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 2a, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Interventional Study to Assess the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of Multiple IV Doses of Bermekimab for the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis
• Actual Study Start Date: Sep 2, 2021
• Actual Primary Completion Date: Mar 9, 2022
• Actual Study Completion Date: Mar 9, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part A: Bermekimab Dose 1 Participants will receive bermekimab Dose 1 or placebo as an intravenous (IV) infusion weekly from Week 0 to Week 15.	Drug: Bermekimab; Participants will receive bermekimab IV.; Other Names: JNJ-77474462 ; Drug: Placebo; Participants will receive placebo IV.
Experimental: Part B: Bermekimab Dose 2 Participants will receive bermekimab Dose 2 or placebo as an IV infusion weekly from Week 0 to Week 15.	Drug: Bermekimab; Participants will receive bermekimab IV.; Other Names: JNJ-77474462 ; Drug: Placebo; Participants will receive placebo IV.
Experimental: Part C: Bermekimab Dose 3 Participants will receive bermekimab or placebo at a higher or lower dose (not less than [<] Dose 1) than Part B, but with a maximum dose of Dose 3 IV weekly based on pharmacokinetic (PK), pharmacodynamic (PD), efficacy, and safety analysis.	Drug: Bermekimab; Participants will receive bermekimab IV.; Other Names: JNJ-77474462 ; Drug: Placebo; Participants will receive placebo IV.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants with Eczema Area and Severity Index (EASI)-75 (Greater Than or Equal to [>=] 75 Percent [%] Improvement from Baseline) at Week 16 [Week 16]

   The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis (AD). The EASI is a composite index with scores ranging from 0 to 72, with higher score indicative of more severe disease. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) will each be assessed for severity by the investigator or designee on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement will be assessed as a percentage by body area of head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6 in which 0 indicates 'no eruption', 1 indicates '<10%, 2 indicates '<10%-29%', 3 indicates '<30%-49%', 4 indicates '<50%-69%', 5 indicates ' <70%-89%', and 6 indicates '>90%-100%'.

Secondary Outcome Measures

1. Serum Concentrations of Bermekimab [Up to week 16]

   Serum concentrations of bermekimab over time will be reported.

2. Number of Participants with Antibodies to Bermekimab (Anti-Drug Antibodies [ADAs] and Neutralizing Antibodies [NAbs]) [Up to week 16]

   Number of participants with antibodies to bermekimab (ADAs and NAbs) will be reported.

3. Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) [Up to week 20]

   An adverse event (AE) is 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 pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.

4. Percentage of Participants with Treatment-emergent Serious Adverse Events (TESAEs) [Up to week 20]

   A serious adverse event based on International Council for Harmonization (ICH) and European Union (EU) guidelines on pharmacovigilance for medicinal products for human use is any untoward medical occurrence that at any dose: a) results in deaths; b) life-threatening (the participant was at risk of death at the time of the event. It does not refer to an event that hypothetically might have caused death if it were more severe.); c) requires inpatient hospitalization or prolongation of existing hospitalization; d) results in persistent or significant disability/incapacity; e) is a congenital anomaly/birth defect; f) is a suspected transmission of any infectious agent via a medicinal product; g) is medically important.

5. Percentage of Participants with Adverse Events (AEs) Leading to Discontinuation of Study Intervention [Up to week 20]

   Percentage of participants with AEs leading to discontinuation of study intervention will be reported.

6. Percentage of Participants with AEs Reasonably Related to Study Intervention [Up to week 20]

   Percentage of participants with AEs reasonably related to study intervention will be reported.

7. Percentage of Participants with AEs of Infusion-related Reactions. [Up to week 20]

   Percentage of participants with AEs of infusion-related reactions will be reported.

8. Percentage of Participants with AEs of Infections [Up to week 20]

   Percentage of participants with AEs of infections, including serious infections and infections requiring oral or parenteral antimicrobial treatment will be reported.

9. Percentage of Participants with Clinically Significant Abnormalities in Vital Signs [Up to week 20]

   Percentage of participants with clinically significant abnormalities in vital signs (temperature, pulse/heart rate, respiratory rate, and blood pressure) will be reported.

10. Percentage of Participants with Clinically Significant Abnormalities in Laboratory Parameters [Up to week 20]

    Percentage of participants with clinically significant abnormalities in laboratory parameters (blood chemistry, urinalysis, and hematology) will be reported.

11. Percentage of Participants with Both validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Score of 0 or 1 and a Reduction from Baseline of >=2 Points [Up to week 16]

    Percentage of participants with both vIGA-AD of 0 or 1 and a reduction from baseline of >=2 points will be reported. The vIGA-AD is an assessment instrument used in clinical studies to rate the severity of AD, based on a 5-point scale ranging from 0 to 4 where 0 indicates clear, 1 indicates 'mostly clear', 2 indicates ' mild', 3 indicates 'moderate', and 4 indicates 'severe'. The IGA score is selected using the morphological descriptors that best describe the overall appearance of the AD lesions at a given time point.

12. Percentage of Participants with Improvement (Reduction) of Eczema-related Itch Numeric Rating Scale (NRS) Score of >=4 from Baseline Among Participants with a Baseline Itch Value >=4 [Baseline up to week 16]

    Percentage of participants with improvement (reduction) of eczema-related itch NRS score of >=4 from baseline among participants with a baseline itch value >=4 will be reported. The Eczema Skin Pain and Itch NRS is a 2-item Patient-reported outcome (PRO) developed by the sponsor that participants will use to rate the severity of their eczema-related skin pain. Each item is rated on a 0 to 10 NRS ranging from 0 "none" to 10 "worst possible" and will be scored separately.

13. Percentage of Participants with EASI-90 [Up to week 16]

    Percentage of participants with EASI-90 will be reported. The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis (AD). The EASI is a composite index with scores ranging from 0 to 72, with higher score indicative of more severe disease. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) will each be assessed for severity by the investigator or designee on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement will be assessed as a percentage by body area of head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6 in which 0 indicates 'no eruption', 1 indicates '<10%, 2 indicates '<10%-29%', 3 indicates '<30%-49%', 4 indicates '<50%-69%', 5 indicates '<70%-89%', and 6 indicates '>90%-100%'.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Have atopic dermatitis (AD) for at least 1 year (365 days) prior to the first administration of study intervention as determined by the investigator through participant interview and/or review of the medical history

• Have a history of inadequate response to treatment for AD with topical medications or for whom topical treatments are otherwise medically inadvisable (example, due to important side effects or safety risks)

• Have an Eczema Area and Severity Index (EASI) score greater than or equal to (>=) 16 at screening and at baseline

• Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study

• Must be willing to undergo 4 skin biopsies

• Have an Investigator Global Assessment (IGA) score >=3 at screening and at baseline

• Have an involved body surface area (BSA) >=10 percent (%) at screening and at baseline

Exclusion Criteria:

• Has a current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances

• Has ever received any Human interleukin-1 (IL-1) antagonist (example, including but not limited to anakinra, rilonacept)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dawes Fretzin Clinical Research Group	Indianapolis	Indiana	United States	46256
2	Clinical Research Institute of Michigan, LLC	Chesterfield	Michigan	United States	48047
3	Vital Prospects Clinical Research Institute, PC	Tulsa	Oklahoma	United States	74136
4	Modern Research Associates	Dallas	Texas	United States	75231
5	Progressive Clinical Research	San Antonio	Texas	United States	78213
6	Texas Dermatology and Laser Specialists	San Antonio	Texas	United States	78218
7	Conexa Investigacion Clinica S.A.	Caba		Argentina	C1015AAA
8	STAT Research S.A.	Caba		Argentina	C1023AAB
9	Clínica Adventista Belgrano	Caba		Argentina	C1430EGF
10	CARE - Centro de Alergia y Enfermedades Respiratorias	Ciudad Autonoma de Buenos Aires		Argentina	1414
11	CINME - Centro de Investigaciones Metabolicas	Ciudad de Buenos Aires		Argentina	C1056ABJ

Sponsors and Collaborators

• Janssen Research & Development, LLC

Investigators

• Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Janssen Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT04990440
• Other Study ID Numbers: CR109057; 2020-005900-21; 77474462ADM2003
• First Posted: Aug 4, 2021
• Last Update Posted: Apr 14, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dermatitis, Atopic; Dermatitis

Study Results

No Results Posted as of Apr 14, 2022