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
- Conditions
- Moderate to Severe Atopic DermatitisMedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2020-005900-21-DE
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
1. =18 to =65 years old
2. be otherwise healthy on the basis of physical examination and medical history.
3. have AD for at least 1 year prior to the first administration of study intervention.
4. have a history of inadequate response to treatment for AD with topical medications, or for whom topical treatments are otherwise medically inadvisable.
5. have an EASI score =16 at screening and at baseline.
6. have an IGA score =3 at screening and at baseline.
7. have an involved BSA =10% at screening and at baseline.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 53
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7
1. has a current diagnosis or signs or symptoms of severe, progressive, or uncontrolled systemic disturbances.
2. has unstable cardiovascular disease.
3. has signs and symptoms or a history of lymphoproliferative disease.
4. a history of malignancy within 5 years before screening.
5. has a history of chronic or recurrent infectious disease.
6. has or has had a serious infection during the 2 months before screening.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of 16 weeks of multiple IV doses of bermekimab, compared with placebo, in participants with moderate-to-severe AD;Secondary Objective: - To evaluate the pharmacokinetics and immunogenicity<br>- To assess the safety and tolerability<br>- To characterize additional assessments of efficacy;Primary end point(s): Proportion of participants with EASI-75;Timepoint(s) of evaluation of this end point: Baseline through Week 16
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Serum concentrations of bermekimab over time.<br>2. The incidence and titers of antibodies to bermekimab.<br>3. Proportion of participants with treatment-emergent adverse events.<br>4. Proportion of participants with both vIGA-AD of 0 or 1 and a reduction from baseline of =2 points.<br>5. Proportion of participants with improvement of eczema-related itch.<br>6. Proportion of participants with EASI-90.;Timepoint(s) of evaluation of this end point: 1, 2. Through Week 16<br>3. Baseline through Week 20<br>4-6. Through Week 16