jRCT2031240728Not yet recruitingNot Applicable
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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Janssen Pharmaceutical K.K.
- Enrollment
- 240
- Primary Endpoint
- Percentage of Participants with Eczema Area and Severity Index (EASI) 75 Response at Week 12
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized Controlled Trial
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment Purpose
- Masking
- Double Blind
Eligibility Criteria
- Ages
- 18age old over to No limit (—)
- Sex
- All
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 12months 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-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
Outcomes
Primary Outcomes
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% 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 4 anatomic regions of the body: head/neck, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting a higher severity of AD.
Secondary Outcomes
No secondary outcomes reported
Investigators
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