In short
JNJ-95597528 is an investigational protein-based medicine being studied for moderate to severe atopic dermatitis. It is given as a subcutaneous injection. One Phase 2 trial with 174 participants is authorised to compare JNJ-95597528 against placebo, measuring the EASI 75 response at Week 12.
Key points
- JNJ-95597528 is an investigational protein-based substance with no marketing authorisation.
- It is being studied in moderate to severe atopic dermatitis.
- The single registered trial is a Phase 2 study with 174 participants.
- The trial compares JNJ-95597528 with placebo using subcutaneous injections.
- The main outcome measure is EASI 75 at Week 12.
- The trial is currently authorised in the EU Clinical Trials Information System.
What is JNJ-95597528?
JNJ-95597528 is an investigational protein-based substance developed by Janssen-Cilag International N.V. It has no marketing authorisation in the product records, meaning it is not yet an approved medicine. The substance is classified in the therapeutic area of immune system diseases. Its pharmaceutical form is a solution for injection, and it is administered by subcutaneous use.
How does JNJ-95597528 work?
The available registry data do not describe the molecular target or mechanism of action of JNJ-95597528. As a protein-based substance studied in immune system diseases, it is being investigated for its effect on atopic dermatitis, but the specific pathway it acts on is not stated in the trial record.
Which conditions is JNJ-95597528 studied for?
- Moderate to severe atopic dermatitis — a chronic inflammatory skin condition that causes itchy, inflamed skin. The trial focuses on participants whose disease is moderate to severe.
How is JNJ-95597528 given?
JNJ-95597528 is prepared as a solution for injection and is given by subcutaneous use, which means it is injected under the skin. The trial record does not report a specific dose, as the concentration is listed as 0 mg/ml, indicating the dose was not disclosed in the register.
What do the clinical trials show?
One Phase 2 trial of JNJ-95597528 is registered in the EU Clinical Trials Information System. The trial, titled "A Study of JNJ-95597528 in the Treatment of Participants With Moderate to Severe Atopic Dermatitis", is authorised and plans to enrol 174 participants.
The study is interventional and compares JNJ-95597528 with a placebo, both given by subcutaneous injection. The primary outcome measure is the EASI 75 response at Week 12, which assesses the proportion of participants achieving at least a 75% improvement in the Eczema Area and Severity Index (EASI) score.
The trial record does not specify detailed eligibility criteria, but the condition studied is moderate to severe atopic dermatitis. The status "authorised" means the trial has received regulatory approval to proceed.
What side effects are known?
No side effect information for JNJ-95597528 is available in the provided sources. As an investigational substance in an early phase of clinical research, its safety profile is still being evaluated.