In short
Camoteskimab is an investigational monoclonal antibody being studied in inflammatory diseases. In the EU Clinical Trials Information System, one authorised Phase 2b trial is registered, planning to enrol 280 adults with moderate-to-severe atopic dermatitis. The study compares camoteskimab given by subcutaneous injection against placebo, measuring the change in the Eczema Area and Severity Index (EASI) at Week 24. Camoteskimab has also received orphan drug designation from the U.S.
Key points
- Camoteskimab is an investigational monoclonal antibody for inflammatory conditions.
- One Phase 2b trial is registered in the EU CTIS for atopic dermatitis.
- The trial plans to enrol 280 adults with moderate-to-severe atopic dermatitis.
- The primary measure is the percentage change in EASI from baseline at Week 24.
- Camoteskimab is given by subcutaneous injection.
- It has orphan drug designation from the FDA for Still's disease, including adult-onset Still's disease and systemic juvenile idiopathic arthritis.
What is camoteskimab?
Camoteskimab is an investigational monoclonal antibody, a type of protein-based substance designed to target specific molecules involved in inflammation. It is not yet authorised as a medicine in the European Union or the United States. The substance is being developed by Apollo Therapeutics Inc., based in Boston, Massachusetts, which is listed as the sponsor in the U.S. Food and Drug Administration orphan drug designation record.
In February 2024, the FDA granted camoteskimab orphan drug designation for the treatment of Still's disease, a rare inflammatory condition that includes adult-onset Still's disease and systemic juvenile idiopathic arthritis. Orphan designation is a status given to medicines being developed for rare diseases. The FDA record indicates that the designation status is designated or has been withdrawn or revoked, and that camoteskimab is not FDA approved for this orphan indication.
How does camoteskimab work?
Camoteskimab is a monoclonal antibody, which means it is a laboratory-produced protein designed to bind to a specific target in the body. The registered clinical trial and the orphan drug designation record describe camoteskimab as being studied in inflammatory diseases such as atopic dermatitis and Still's disease, but the precise molecular target of camoteskimab is not stated in the available sources. As an investigational antibody, its mechanism of action is being evaluated in clinical studies.
Which conditions is camoteskimab studied for?
- Atopic dermatitis (AD) — a chronic inflammatory skin condition that causes dry, itchy and inflamed skin. The registered Phase 2b trial is investigating camoteskimab in adults with moderate-to-severe atopic dermatitis.
- Still's disease, including adult-onset Still's disease and systemic juvenile idiopathic arthritis — rare inflammatory conditions that cause fever, rash and joint inflammation. Camoteskimab received orphan drug designation from the FDA for this condition in 2024.
How is camoteskimab given?
In the registered clinical trial, camoteskimab is given by subcutaneous injection, which means it is injected under the skin. The trial also includes a placebo arm using an isotonic sodium chloride solution given by subcutaneous injection. No other pharmaceutical forms or routes of administration are described in the available sources.
What do the clinical trials show?
One clinical trial of camoteskimab is registered in the EU Clinical Trials Information System. It is a Phase 2b study investigating the effects of camoteskimab in adults with moderate-to-severe atopic dermatitis. The trial is authorised, meaning it has received regulatory approval to proceed, and plans to enrol 280 participants.
What is the trial measuring?
The primary outcome of the trial is the percentage change from baseline in the Eczema Area and Severity Index (EASI) at Week 24. EASI is a tool used to measure the extent and severity of atopic dermatitis. The study compares camoteskimab against placebo to assess its clinical efficacy in participants with moderate-to-severe atopic dermatitis.
Who can take part?
The trial enrols adults with moderate-to-severe atopic dermatitis. The registered record does not provide further details on specific inclusion or exclusion criteria beyond this population description.
What side effects are known?
The available sources do not provide information on side effects of camoteskimab. As an investigational substance, its safety profile is being evaluated in clinical trials. The registered Phase 2b study in atopic dermatitis will contribute safety data, but no specific side effects are reported in the registry record or the FDA orphan drug designation listing.