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JNJ-95597528 · 2 trials · 2 indications
Participant who experiences intercurrent events (ICEs) in categories 5 or 6 after treatment initiation and prior to Week 48 is considered to have an asthma exacerbation. An asthma exacerbation is defined as a worsening of asthma that requires a medical intervention and/or results in death. A worsening of asthma is defined as: worsening of asthma signs/symptoms; increased use of 'as needed' reliever medication; deterioration of lung function that is, peak expiratory flow, forced expiratory volume in 1 second (FEV1).
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.
| Arm | Type | Description |
|---|---|---|
| Group 1: JNJ-95597528: Dose 1 | EXPERIMENTAL | Participants will receive JNJ-95597528 Dose 1 at Weeks 0, 2, 12, 24 and 36. |
| Group 2: JNJ-95597528: Dose 2 and Dose 3 | EXPERIMENTAL | Participants will receive JNJ-95597528 Dose 2 at Week 0, placebo at Week 2 then JNJ-95597528 Dose 3 at Weeks 12, 24 and 36. |
| Group 3: JNJ-95597528: Dose 4 and 5 | EXPERIMENTAL | Participants will receive JNJ-95597528 Dose 4 at Week 0, placebo at Week 2 then JNJ-95597528 Dose 5 at Weeks 12, 24 and 36. |
| Group 4: Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo doses at Weeks 0, 2, 12, 24, and 36. |
| Group 1: JNJ-95597528 (Dose 1) | EXPERIMENTAL | Participants will receive JNJ-95597528 Dose 1 on Weeks 0, 2, 12, and 24. |
| Group 2: JNJ-95597528 (Dose 2 and 3) | EXPERIMENTAL | Participants will receive JNJ-95597528 Dose 2 on Week 0 followed by JNJ-95597528 Dose 3 on Weeks 12, and 24. |
| Group 3: JNJ-95597528 (Dose 4 and 5) | EXPERIMENTAL | Participants will receive JNJ-95597528 Dose 4 on Week 0 followed by JNJ-95597528 Dose 5 on Weeks 12, and 24. |
| Group 4: Placebo and JNJ-95597528 (Dose 2 and 3) | PLACEBO_COMPARATOR | Participants will receive placebo from Weeks 0 to 12 , then switch to receive JNJ-95597528 Dose 2 administered at Week 12 followed by Dose 3 at Week 24. |
| Name | Type | Description |
|---|---|---|
| JNJ-95597528 | DRUG | JNJ-95597528 will be administered as subcutaneous (SC) injection. |
| Placebo | DRUG | Placebo will be administered as SC injection. |
Inclusion criteria: * Medically stable on the basis of physical examination, medical history, and vital signs performed at screening or at baseline * Confirmed variable expiratory flow (1 or more of the following) per global initiative for asthma (GINA) 2025 at the baseline visit: a. Evidence of br...
JNJ-95597528 is an investigational small molecule being developed by Johnson & Johnson (JNJ) for the treatment of moderate to severe atopic dermatitis and inadequately controlled moderate to severe asthma. It is currently in Phase 2 clinical development for both indications.
The specific molecular target of JNJ-95597528 has not been disclosed in available information. It is classified as a small molecule therapeutic in the respiratory therapeutic area, but its mechanism of action is not publicly detailed.
JNJ-95597528 is being developed by Johnson & Johnson, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol JNJ. The company is conducting Phase 2 clinical trials for this investigational drug.
JNJ-95597528 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 2 trials are listed: one for atopic dermatitis and one for asthma, with the asthma trial not yet recruiting participants.
JNJ-95597528 is being studied in two Phase 2 trials. NCT07230860 is an active, not recruiting study in 189 participants with moderate to severe atopic dermatitis across multiple countries. NCT07746687 is a not yet recruiting study in 440 participants with inadequately controlled moderate to severe asthma.
No alternative names for JNJ-95597528 have been reported. The drug is identified solely by its development code JNJ-95597528 in clinical trial registries and company communications.