Study on the Effectiveness and Safety of JNJ-95475939 and Dupilumab for Treating Moderate to Severe Atopic Dermatitis in Adults
- Participants:Adults
Rare diseases
Investigational molecules
Locations
NM26-2198, also known as JNJ-95475939, is an investigational bispecific, tetravalent antibody. It is a protein-based substance developed for the treatment of moderate to severe atopic dermatitis, a chronic inflammatory skin condition.[3] The substance has no marketing authorisation in the product records, meaning it is still being studied in clinical trials and is not available as a licensed medicine.[1] The authorisation holder listed in the trial record is Janssen-Cilag International N.V.[1]
NM26-2198 is designed as a bispecific antibody, meaning it can bind to two different targets at the same time. According to a review of emerging therapies, it targets both inflammatory and pruritogenic (itch-related) pathways involved in atopic dermatitis.[3] Most currently approved biologic treatments for atopic dermatitis target only one molecule, whereas multi-specific antibodies such as NM26-2198 are intended to block several pathways at once. This approach is being explored because many patients treated with single-target biologics still do not achieve clear or almost clear skin.[2] The review lists NM26-2198 among a growing group of bispecific and trispecific antibodies being developed for atopic dermatitis.[2]
NM26-2198 is formulated as a solution for injection and is given by subcutaneous use, meaning it is injected under the skin.[1] The trial compared NM26-2198 with dupilumab (Dupixent), which was also given subcutaneously, and with a placebo version of NM26-2198.[1]
One Phase 2b trial of NM26-2198 is registered. It was a multicentre, randomised, double-blind study that included 240 participants with moderate to severe atopic dermatitis.[1] The trial was designed to evaluate the efficacy and safety of different doses of NM26-2198 compared with placebo and with dupilumab.[1] The primary outcome was EASI 75 at Week 12, which measures the proportion of participants achieving at least a 75% improvement in the Eczema Area and Severity Index (EASI) from the start of the study.[1] The trial is listed as completed, but the registry records do not include the results.[1]
The available sources do not provide specific information on side effects observed with NM26-2198. No safety data from the completed trial or from other publications are described in the records provided.
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