Clinical trial NCT06881251: A Study of JNJ-95475939 in the Treatment of Participants With Moderate to Severe Atopic Dermatitis (AD)
Official title: 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 AD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Dermatitis, Atopic
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2025-03-18
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate how well JNJ-95475939 works as compared to placebo in participants with moderate to severe atopic dermatitis.


Eligibility criteria: Inclusion criteria:

* 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 12 months before screening)
* Participant has applied a moisturizer at least once daily for at least 7 days before the baseline visit

Exclusion criteria:

* 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-4Rα, 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

Primary outcomes:
measure: Percentage of Participants with Eczema Area and Severity Index (EASI) 75 Response at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Percentage of Participants With EASI-90 Response at Week 12
timeFrame: Baseline, Week 12
measure: Percentage of Participants With EASI-100 Response at Week 12
timeFrame: Baseline, Week 12
measure: Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Score of 0 or 1 and a Reduction From Baseline of Greater Than Equal to (>=) 2 Points at Week 12
timeFrame: Baseline, Week 12
measure: Percentage of Participants Achieving vIGA-AD Score of 0 and a Reduction From Baseline of >= 2 Points at Week 12
timeFrame: Baseline, Week 12
measure: Percent Change From Baseline in the EASI Total Score at Week 12
timeFrame: Baseline, Week 12
measure: Percentage of Participants Achieving a >= 4-Point Reduction in Skin Pain Numerical Rating Scale (NRS) Score From Baseline to Week 12
timeFrame: Baseline, Week 12
measure: Percent Change from Baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) Score at Week 12
timeFrame: Baseline, Week 12
measure: Percent Change from Baseline in Skin Pain NRS Score at Week 12
timeFrame: Baseline, Week 12
measure: Percent Change from Baseline in the Score of Item 2 of the AD Sleep Scale at Week 12
timeFrame: Baseline, Week 12
measure: Percentage of Participants Achieving a >= 4-Point Reduction in PP-NRS Score From Baseline Through Week 12
timeFrame: From Baseline through Week 12
measure: Percentage of Participants with EASI-75 Response at Week 16
timeFrame: Baseline, Week 16
measure: Percentage of Participants with EASI-90 Response at Week 16
timeFrame: Baseline, Week 16
measure: Percentage of Participants with EASI-100 Response at Week 16
timeFrame: Week 16
measure: Percentage of Participants Achieving vIGA-AD Score of 0 or 1 and a Reduction From Baseline of >= 2 Points at Week 16
timeFrame: Baseline, Week 16
measure: Percentage of Participants Achieving vIGA-AD Score of 0 and a Reduction From Baseline of >= 2 Points at Week 16
timeFrame: Baseline, Week 16
measure: Percent Change from Baseline in the EASI Total Score at Week 16
timeFrame: Baseline, Week 16
measure: Percentage of Participants Achieving a >= 4-Point Reduction in Skin Pain Numerical Rating Scale (NRS) Score From Baseline to Week 16
timeFrame: Baseline, Week 16
measure: Percent Change from Baseline in PP-NRS Score at Week 16
timeFrame: Baseline, Week 16
measure: Percent Change from Baseline in Skin Pain NRS Score at Week 16
timeFrame: Baseline, Week 16
measure: Percent Change from Baseline in the Score of Item 2 of the AD Sleep Scale at Week 16
timeFrame: Baseline, Week 16
measure: Percentage of Participants Achieving a >= 4-Point Reduction in PP-NRS Score From Baseline Through Week 24
timeFrame: From Baseline Through Week 24
measure: Percentage of Participants with EASI-75 Response at Week 24
timeFrame: Baseline, Week 24
measure: Percentage of Participants with EASI-90 Response at Week 24
timeFrame: Week 24
measure: Percentage of Participants with EASI-100 Response at Week 24
timeFrame: Week 24
measure: Percentage of Participants Achieving vIGA-AD Score of 0 or 1 and a Reduction From Baseline of >= 2 Points at Week 24
timeFrame: Baseline, Week 24
measure: Percentage of Participants Achieving vIGA-AD Score of 0 and a Reduction From Baseline of >= 2 Points at Week 24
timeFrame: Baseline, Week 24
measure: Percent Change from Baseline in the EASI Total Score at Week 24
timeFrame: Baseline, Week 24
measure: Percentage of Participants Achieving a >= 4-Point Reduction in Skin Pain NRS Score From Baseline to Week 24
timeFrame: Baseline, Week 24
measure: Percent Change From Baseline in PP-NRS Score at Week 24
timeFrame: Baseline, Week 24
measure: Percent Change from Baseline in Skin Pain NRS Score at Week 24
timeFrame: Baseline, Week 24
measure: Percent Change from Baseline in the Score of Item 2 of the AD Sleep Scale at Week 24
timeFrame: Baseline, Week 24
measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From Baseline up to Week 32
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: First OC Dermatology
state: California
city: Alpharetta
country: United States
facility: Hamilton Research LLC
state: Georgia
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group LLC
state: Indiana
city: Plainfield
country: United States
facility: Indiana Clinical Trial Center
state: Indiana
city: Boardman
country: United States
facility: Optima Research
state: Ohio
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Arlington
country: United States
facility: Arlington Center for Dermatology
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: Mill Creek
country: United States
facility: Frontier Derm Partners CRO, LLC
state: Washington
city: Buenos Aires
country: Argentina
facility: Instituto de Neumonologia y Dermatologia
city: Buenos Aires
country: Argentina
facility: Derma Internacional S A
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: CIPREC
city: Calgary
country: Canada
facility: Dermatology Research Institute Inc
state: Alberta
city: Surrey
country: Canada
facility: Dr. Chih ho Hong Medical
state: British Columbia
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: Montreal
country: Canada
facility: Innovaderm Research Inc.
state: Quebec
city: Quebec
country: Canada
facility: Centre De Recherche Dermatologique Du Quebec Metropolitain
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim
city: Berlin
country: Germany
facility: ISA - Interdisciplinary Study Association GmbH
city: Hamburg
country: Germany
facility: Eurofins bioskin GmbH
city: Langenau
country: Germany
facility: Studienzentrum Dr Schwarz Germany
city: Fukuoka-shi
country: Japan
facility: Fukuoka University Hospital
city: Habikino
country: Japan
facility: Osaka Habikino Medical Center
city: Itabashi Ku
country: Japan
facility: Teikyo University Hospital
city: Sakai City
country: Japan
facility: Kume Clinic
city: Sapporo shi
country: Japan
facility: Sapporo Skin Clinic
city: Tachikawa
country: Japan
facility: Jitaikai Tachikawa dermatology clinic
city: Takaoka shi
country: Japan
facility: Shirasaki Dermatology Clinic
city: Tsu
country: Japan
facility: Mie University Hospital
city: Yokohama
country: Japan
facility: Queens Square Medical Facilities
city: Yokohama
country: Japan
facility: Nomura Dermatology Clinic
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI House sp z o o
city: Katowice
country: Poland
facility: Care Clinic
city: Krakow
country: Poland
facility: Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna
city: Krakow
country: Poland
facility: Centrum Medyczne All Med
city: Lodz
country: Poland
facility: Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
city: Warszawa
country: Poland
facility: Klinika Ambroziak Dermatologia
city: Wroclaw
country: Poland
facility: WroMedica I Bielicka A Strzalkowska s c
city: Alicante
country: Spain
facility: Hosp. Gral. Univ. Dr. Balmis
city: Granada
country: Spain
facility: Hosp. Univ. San Cecilio
city: Madrid
country: Spain
facility: Grupo Dermatologico Y Estetico Pedro Jaen
city: Madrid
country: Spain
facility: Hosp. Univ. de La Princesa
city: Manises
country: Spain
facility: Hosp. de Manises
city: Santiago de Compostela
country: Spain
facility: Hosp. Clinico Univ. de Santiago
city: London
country: United Kingdom
facility: Northwick Park Hospital
city: London
country: United Kingdom
facility: Guys and St Thomas NHS Foundation Trust
city: Norfolk
country: United Kingdom
facility: The Queen Elizabeth Hospital King's Lynn NHS Foundation Trust
city: Salford
country: United Kingdom
facility: Salford Royal Hospital
Study officials:
References: