Moderate to Severe Atopic Dermatitis MedDRA version: 21.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858
Conditions
Interventions
Product Name: bermekimab
Product Code: JNJ-77474462
Pharmaceutical Form: Solution for infusion in pre-filled syringe
INN or Proposed INN: bermekimab
Current Sponsor code: JNJ-77474462
Other descriptiv
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 - To assess the safety and tolerability - 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Serum concentrations of bermekimab over time. 2. The incidence and titers of antibodies to bermekimab. 3. Proportion of participants with treatment-emergent adverse events. 4. Proportion of participants with both vIGA-AD of 0 or 1 and a reduction from baseline of =2 points. 5. Proportion of participants with improvement of eczema-related itch. 6. Proportion of participants with EASI-90.;Timepoint(s) of evaluation of this end point: 1, 2. Through Week 16 3. Baseline through Week 20 4-6. Through Week 16 | — |
Countries
Argentina, Germany, Hungary, Ukraine, United States
Contacts
Public ContactJBBV Clinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed