A Study of JNJ-95597528 in Participants With Moderate to Severe Atopic Dermatitis
ConditionDermatitis, Atopic
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJanssen Research & Development, LLC
About this trial
The purpose of this study is to assess how well JNJ-95597528 works compared to placebo in participants with moderate to severe atopic dermatitis (AD).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Be otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
Meets all the following disease activity criteria: a. Chronic atopic dermatitis (AD), according to American Academy of Dermatology Consensus Criteria with onset of symptoms at least 1 year prior to screening visit; b. Eczema area and severity index (EASI) score greater than or equal to (>=) 16 at the screening and Week 0; c. validated investigator global assessment for atopic dermatitis (vIGA-AD) score >= 3 at screening and Week 0; d. >= 10% body surface area (BSA) of AD involvement at screening and Week 0; e. Documented history (within 6 months before screening) of either inadequate response or inadvisability to medicated topical treatments for AD or inadequate response to systemic therapies (within 12 months before screening)
Must sign an informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
If willing to participate in the substudy, must sign a separate ICF for the corresponding substudy (or substudies)
Disqualifiers
History of substance abuse or alcohol abuse within 1 year before screening
In the investigator's opinion, any clinically significant results from the 12-lead ECG, chemistry, hematology, or urinalysis laboratory tests obtained at the screening visit that would affect interpretation of study data or the participant's safety in the study
Known or suspected immunodeficiency, including history of invasive opportunistic infections
Previously received JNJ-95597528
Trial design
Design model
Parallel
Treatments tested in this trial
JNJ-95597528
DrugJNJ-95597528 will be administered subcutaneously.
Placebo
DrugPlacebo will be administered subcutaneously.
Treatment groups
180 Participants
are divided into 4 treatment groupsGroup A: Group 1: JNJ-95597528 (Dose 1)Experimental treatment 1 intervention
Group B: Group 2: JNJ-95597528 (Dose 2 and 3)Experimental treatment 1 intervention
Group C: Group 3: JNJ-95597528 (Dose 4 and 5)Experimental treatment 1 intervention
Group D: Group 4: Placebo and JNJ-95597528 (Dose 2 and 3)Placebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Proportion of Participants with Eczema Area and Severity Index (EASI) 75 Response at Week 12
EASI-75 response is defined as at least 75 percent (%) improvement from baseline in EASI total score. EASI is a validated measure used to assess the severity and extent of AD with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) will each be assessed for severity by the investigator or designee on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement will be assessed as a percentage by body area of head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Here higher score indicates higher severity of AD.
Time frame
Week 12Secondary outcomes
1
Proportion of Participants with EASI 90 Response at Week 12
EASI-90 response is defined as at least 90% improvement from baseline in EASI total score. EASI is a validated measure used to assess the severity and extent of AD with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) will each be assessed for severity by the investigator or designee on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement will be assessed as a percentage by body area of head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Here higher score indicates higher severity of AD.
Time frame
Week 122
Proportion of Participants with EASI 100 Response at Week 12
EASI-100 response is defined as at least 100% improvement from baseline in EASI total score. EASI is a validated measure used to assess the severity and extent of AD with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) will each be assessed for severity by the investigator or designee on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement will be assessed as a percentage by body area of head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Here higher score indicates higher severity of AD.
Time frame
Week 123
Percent Change from Baseline in EASI Total Score at Week 12
Percent change from baseline in EASI total score will be reported. EASI is a validated measure used to assess the severity and extent of AD with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) will each be assessed for severity by the investigator or designee on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement will be assessed as a percentage by body area of head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Here higher score indicates higher severity of AD.
Time frame
Baseline, Week 124
Proportion of Participants with Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Score of 0 or 1 and a Reduction of >= 2 Points from Baseline, at Week 12
Proportion of participants with vIGA-AD score of 0 or 1 and a reduction of \>=2 points from baseline at Week 12 will be reported. vIGA-AD is an assessment instrument used in clinical studies to rate the severity of AD, based on a 5-point scale ranging from 0 (clear) to 4 (severe). The IGA score is selected using the morphological descriptors that best describe the overall appearance of the AD lesions at a given time point. Higher scores are indicative of a more severe AD.
Time frame
Week 12Sponsors and contacts
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Source ClinicalTrials.gov