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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

A Study of JNJ-95475939 in the Treatment of Participants with Moderate to Severe Atopic Dermatitis (AD) (DUPLEX-AD)

Kawahara Kensaku

Janssen Pharmaceutical K.K.

5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo

DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com

Medical Information Center

Janssen Pharmaceutical K.K.

5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo

+81-120-183-275

DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com

Not Recruiting

May. 16, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

-Chronic Atopic Dermatitis (AD), according to American Academy of Dermatology Consensus Criteria with onset of symptoms at least 1 year prior to the screening visit
-Eczema Area and Severity Index (EASI) score greater than and equal to (>=) 16 at the screening and baseline visits
-Validated investigator global assessment for AD (vIGA-AD) score >= 3 at the screening and baseline visits
- >= 10% body surface area (BSA) of AD involvement at the screening and baseline visits
-Baseline Peak Pruritus Numeric(al) Rating Scale (PP-NRS) average score of >=4
-Documented history (within 6 months before screening) of either inadequate response or inadvisability to topical treatments, or inadequate response to systemic therapies (within 12months before screening)
-Participant has applied a moisturizer at least once daily for at least 7 days before the baseline visit

-Experienced primary efficacy failure (no response within 16 weeks) or an adverse event(AE) requiring discontinuation related to agents (eg, severe ocular surface disease, dupilumab-associated facial redness) inhibiting IL-4Ralpha, IL-4, and/or IL-13 signaling (eg,dupilumab, lebrikizumab, or tralokinumab)
-Participant is pregnant or breastfeeding, or planning to become pregnant or breastfeed during the study
-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
-Current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal,cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic,rheumatologic, psychiatric, or metabolic disturbances
-Recent case of eczema herpeticum, herpes zoster within 8 weeks before screening, or history of recurrent eczema herpeticum
-History of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (eg, untreated latent tuberculosis), recurrent urinary tract infection, fungal infection, mycobacterial infection, or open, draining, or infected skin wounds, or ulcers.
-Diagnosed active parasitic infection or at high risk of parasitic infection, unless treated with antihelminth therapy prior to randomization
-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

Both

Dermatitis, Atopic

Active Comparator: Group A: Dupilumab
Participants will receive Dupilumab dose regimen 1 subcutaneously through Week 22.
Drug: Dupilumab
Dupilumab will be administered subcutaneously.

Experimental: Group B: JNJ-95475939
Participants will receive JNJ-95475939 dose regimen 1 subcutaneously through Week 22.
Drug: JNJ-95475939
JNJ-95475939 will be administered subcutaneously.

Experimental: Group C: JNJ-95475939
Participants will receive JNJ-95475939 dose regimen 2 subcutaneously through Week 22.
Drug: JNJ-95475939
JNJ-95475939 will be administered subcutaneously.

Experimental: Group D: JNJ-95475939
Participants will receive JNJ-95475939 dose regimen 3 subcutaneously through Week 22.
Drug: JNJ-95475939
JNJ-95475939 will be administered subcutaneously.

Placebo Comparator: Group E: Placebo
Participants will receive matching placebo subcutaneously through Week 10, then switch to receive JNJ-95475939 dose regimen 1 subcutaneously between Week 12 and Week22.
Drug: JNJ-95475939
JNJ-95475939 will be administered subcutaneously.
Drug: Placebo
Placebo will be administered subcutaneously.

1.Percentage of Participants with Eczema Area and Severity Index (EASI) 75 Response at Week 12 [Time Frame: Baseline, Week 12]
EASI-75 response is defined as at least 75 percent (%) improvement in EASI total score.EASI-75 response is defined as at least 75% improvement from baseline in EASI total score. The EASI score is used to measure the severity and extent of atopic dermatitis (AD)and measures erythema, infiltration/papulation, excoriation and lichenification on 4anatomic regions of the body: head/neck, trunk, upper and lower extremities. The total EASIscore ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting ahigher severity of AD.

Refer to Appendix

+81-42-648-5551

Feb. 14, 2025

Yes

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and 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.

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