A Phase 2b, Multicenter, Randomized, Double-blind, Placebo- and Active-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of JNJ-95475939 for the Treatment of Participants with Moderate to Severe Atopic Dermatitis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Janssen Cilag International

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

30 Apr 2025 → 27 Mar 2026

Decision date (initial)

2025-04-28

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Janssen Research & Development, LLC

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacogenomic, Safety, Pharmacokinetic, Others

To evaluate the efficacy of JNJ 95475939 relative to placebo in participants with moderate to severe AD

Conditions and MedDRA coding

Moderate to Severe Atopic Dermatitis

Regulatory references

Scientific advice from competent authorities

Paul-Ehrlich-Institut

Plan to share IPD

Yes

IPD plan description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 1. ≥18 years of age (or at least the legal age of consent in the jurisdiction in which the study is taking place) at the time of informed consent.
2. 2. Be otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead ECG 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. 3. Meets all the disease activity criteria as stated in the protocol: a. Chronic AD, according to American Academy of Dermatology Consensus Criteria (Eichenfield 2014) with onset of symptoms at least 1 year prior to screening visit as determined by the investigator through participant interview and/or review of the medical history. b. EASI score ≥16 at the Screening and Baseline Visits; c. vIGA-AD score ≥3 at the Screening and Baseline Visits; d. ≥10% BSA of AD involvement at the Screening and Baseline Visits; e. Baseline PP-NRS average score of ≥4 (Protocol Section 8.2.1.1). f. Documented history (within 6 months before screening) of either inadequate response or inadvisability to topical treatments, or inadequate response to systemic therapies (within 12 months before screening) g. Participant has applied a moisturizer at least once daily for at least 7 days before the Baseline Visit.
4. 4. A female participant, while enrolled in this study or within 98 days (14 weeks) after the last dose of study intervention, must: a. Agree to not be pregnant, breastfeeding, or plan to become pregnant. b. Agree to not donate gametes (ie, eggs) or freeze for future use for the purposes of assisted reproduction. c. Either not of childbearing potential (as defined in Section 10.4), or if of childbearing potential: 1) have a negative highly sensitive (eg, β-hCG) pregnancy test at screening and a negative urine pregnancy test at Week 0 prior to administration of study intervention and agree to further pregnancy tests. 2) practice at least 1 highly effective method of contraception. The investigator must evaluate the potential for contraceptive method failure (eg, noncompliance, recently initiated) in relationship to the first dose of study intervention. The method selected must meet local/regional regulations/guidelines. a. A female participant using oral contraceptives must use an additional contraceptive method
5. 5. A male participant, while enrolled in this study and for at least 98 days (14 weeks) after the last dose of study intervention, must: a. Agree not to plan to father a child b. Agree not to donate sperm or freeze for future use for the purposes of assisted reproduction. c. A male participant who has not had a vasectomy must agree to use a barrier method of birth control (eg, either wear a condom [with spermicidal foam/gel/film/cream/suppository if available in their locale] or a partner with an occlusive cap [diaphragm or cervical/vault caps] plus spermicidal foam/gel/film/cream/suppository if available in their locale) when engaging in any activity that allows for passage of ejaculate to a female of childbearing potential during the study and for 98 days (14 weeks) after the last dose of study intervention. Male participants must also be advised of the benefit for a female partner to use a highly effective method of contraception as condom may break or leak.

Exclusion criteria 5

1. 1. Active skin disease other than AD including eczema herpeticum, molluscum contagiosum, impetigo, psoriasis or has any other ongoing significant skin condition including skin infections, that, according to the investigator, could interfere with efficacy assessments.
2. 2. Current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances.
3. 3. Had major surgery (eg, requiring general anesthesia and hospitalization), within 8 weeks before screening, or will not have fully recovered from surgery, or has such surgery planned during the time the participant is expected to participate in the study.
4. 4. Has a transplanted organ (with exception of a corneal transplant >12 weeks before the first administration of study intervention).
5. 5. Uncontrolled chronic disease that might require bursts of oral corticosteroids including co-morbid severe uncontrolled asthma (eg, history of ≥2 asthma exacerbations within the last 12 months requiring systemic [oral and/or parenteral] corticosteroid treatment or hospitalization for >24 hours).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. EASI 75 at Week 12

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Janssen Cilag International

Sponsor organisation

Janssen Cilag International

Address

Turnhoutseweg 30

City

Beerse

Postcode

2340

Country

Belgium

Scientific contact point

Organisation

Janssen Cilag International

Contact name

CTIS Point of Contact

Public contact point

Organisation

Janssen Cilag International

Contact name

CTIS Point of Contact

Third parties 10

Locations

3 EU/EEA countries · 26 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 44 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications