E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | |
E.1.1.1 | Medical condition in easily understood language | An itchy inflammation of the skin | |
E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 | E.1.2 | Level | LLT | E.1.2 | Classification code | 10003639 | E.1.2 | Term | Atopic dermatitis | E.1.2 | System Organ Class | 100000004858 | |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial | The primary objective is to evaluate the efficacy of JNJ-67484703 in patients with moderate to severe AD | |
E.2.2 | Secondary objectives of the trial | 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. | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. | |
E.4 | Principal exclusion criteria | 20.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 21.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 22.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. 23.Treatment with TCS, TCI, topical crisaborole, or topical janus kinase inhibitor within 1 week before the baseline visit. 24.Has ever received any PD-1 agonist (Rosnilimab, LY3462817, etc) | |
E.5 End points |
E.5.1 | Primary end point(s) | 1. Proportion of participants with EASI-75 (≥75% improvement from baseline) | |
E.5.1.1 | Timepoint(s) of evaluation of this end point | |
E.5.2 | 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. | |
E.5.2.1 | Timepoint(s) of evaluation of this end point | 1-4. Week 12 5. Week 1, 4 and 6 6-7. Throughout the study | |
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description | Tolerability, Biomarker analysis, and Immunogenicity | |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 | The trial involves single site in the Member State concerned | No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 11 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned | |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 | Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial | The end of study is considered as the last scheduled Week 36 study assessment for the last participant in the study. | |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 23 |