Actively Recruiting
A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Camoteskimab in Adults With Moderate-to-Severe Atopic Dermatitis
Led by Apollo Therapeutics Ltd · Updated on 2026-06-02
280
Participants Needed
85
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating camoteskimab, a drug being studied in adults with moderate-to-severe atopic dermatitis. This phase 2b study is multicenter, randomized, double-blind, and placebo-controlled, aiming to assess the drugs effects compared to placebo. Participants include those who have not been treated before and those who have had an inadequate response to previous biologic therapies. The study has two parts Part 1 is a 24-week period where participants are randomly assigned to one of four groups receiving one of three doses of camoteskimab or a placebo, all given by subcutaneous injection. In Part 2, an extension period, all participants will receive camoteskimab. This design allows researchers to compare the drug doses with placebo initially and then provide treatment to all participants. Participants will be involved for at least 24 weeks in the placebo-controlled phase and beyond during the extension. They will undergo assessments including the Eczema Area and Severity Index EASI, Investigator Global Assessment IGA, and peak itch ratings. Researchers will measure changes in eczema severity, itch intensity, and skin condition over time. Safety and adherence will be monitored throughout the study period to evaluate the drugs effects and tolerability.
CONDITIONS
Brief Title
A Phase 2b Study of the Effects of Camoteskimab in Adults With Moderate-to-Severe Atopic Dermatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years at the time of informed consent
- Chronic atopic dermatitis for at least 1 year confirmed by clinical diagnosis
- Moderate-to-severe atopic dermatitis defined by: IGA score of 3 or higher at screening and baseline
- Atopic dermatitis affecting 10% or more of body surface area at screening and baseline
- EASI score of 16 or higher at screening and baseline
- Peak pruritus numerical rating scale (PP-NRS) score of 4 or higher at baseline with at least 4 daily scores out of 7 days
- Candidates for systemic therapy due to inadequate response to topical treatments or medical inadvisability of topical treatments
- Use of contraception consistent with local regulations for clinical studies
- Signed informed consent provided
You will not qualify if you...
- Severe illness or psychiatric conditions such as severe depression or suicidal attempt in past 10 years judged unsuitable for the study
- Active infection requiring systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before baseline
- Other active skin diseases or infections that affect atopic dermatitis evaluation
- Significant flares of atopic dermatitis within 4 weeks before screening
- Severe comorbidities requiring systemic steroids or frequent monitoring
- Clinically significant ECG abnormalities affecting QTc interval assessment
- Severe uncontrolled seasonal or allergic rhinitis, asthma, or other atopic diseases
- Use of medicated moisturizers by prescription within 2 weeks prior to baseline
- Active HIV, hepatitis B, hepatitis C (unless cured), or tuberculosis
- Live or attenuated live vaccine within 6 weeks before screening
- Major surgery within 8 weeks before baseline or planned during the study
- Known immune deficiency or immunocompromised state
- Malignancy diagnosed within 5 years except certain skin or cervical cancers
- Previous exposure to anti-IL-18 therapy
- Known allergy to any component of the investigational product
- Recent use of specific medications affecting atopic dermatitis including certain biologics, JAK inhibitors, topical and systemic treatments within specified time frames
- Pregnancy, breastfeeding, or trying to conceive
- Unlikely to adhere to treatment or protocol as judged by investigator
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here