Atopic Dermatitis MedDRA version: 21.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858
Conditions
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Be =18 years (or the legal age of consent in the jurisdiction in which the study is taking place). 2. Be otherwise healthy on the basis of physical examination and vital signs performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator. 3. Have a diagnosis of Atopic Dermatitis for at least 12 months (365 days) before the first administration of study intervention as determined by the investigator through participant interview and/or review of the medical history. 4. Have an EASI score =16 at screening and at baseline. 5. Have a vIGA-AD score of =3 at screening and at baseline. 6. Have a body surface area = 10 at screening and at baseline. 7. Must have a body weight in the range of 50 to 180 kg inclusive. 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 46 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. Has received any of the following treatments within 4 weeks before the baseline visit or any condition that in the opinion of the investigator, is likely to require such treatment during the first 4 weeks of study treatment: • Immunosuppressive/ immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-gamma, systemic Janus kinase inhibitors, azathioprine, methotrexate, etc) • Phototherapy for AD 2. Has previously received treatment with biologics as follows: • an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit • Dupilumab • an immunomodulating biologic within 12 weeks of the baseline visit, or 5 half-lives (if known), whichever is longer (including, but not limited to, anti cytokine, anticomplement antibodies, anti-Ig antibodies, etc). • any cell-depleting agents including but not limited to rituximab; within 6 months before the baseline visit, or until lymphocyte count returns to normal, whichever is longer • Other biologics: within 5 half-lives if known or 16 weeks before the baseline visit 3. Initiation of treatment of AD during screening with any prescription moisturizers or moisturizers containing additives such as ceramides, hyaluronic acid, urea, or filaggrin degradation products during the screening period (see Section 6.8.4) Patients may continue using stable doses of such moisturizers if initiated before the screening visit. 4. Treatment with TCS, TCI, topical crisaborole, or topical janus kinase inhibitor within 1 week before the baseline visit. 5. Has ever received any PD-1 agonist (Rosnilimab, LY3462817, etc)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the efficacy of JNJ-67484703 in patients with moderate to severe AD;Secondary Objective: The secondary objectives are: • To characterize additional efficacy of JNJ-67484703 in participants with moderate to severe AD. • To assess the safety and tolerability of JNJ-67484703 in participants with moderate to severe AD.;Primary end point(s): 1. Proportion of participants with EASI-75 (=75% improvement from baseline);Timepoint(s) of evaluation of this end point: 1. Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Proportion of participants with improvement (reduction) of eczema-related itch NRS =4 from baseline among participants with a baseline itch value =4. 2. Proportion of participants with both vIGA-AD of 0 to 1 and a reduction from baseline of =2 points. 3. Proportion of participants with EASI-90 (=90% improvement from baseline). 4. Percentage change in EASI score from baseline. 5. Percent change from baseline of eczema related itch score (item 2 on ESPI NRS). 6. Number/proportion of participants with treatment-emergent AEs. 7. Number/proportion of participants with treatment-emergent SAEs.;Timepoint(s) of evaluation of this end point: 1-4. Week 12 5. Week 1, 4 and 6 6-7. Throughout the study | — |
Countries
Canada, Germany, Poland
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed