About this trial

This is a phase 2b, multicenter, randomized, double-blind, placebo-controlled study.

Eligibility criteria

Qualifiers

Age 18-65 inclusive, at the time of signing the informed consent.

Chronic AD for at least 1 year based on clinically confirmed diagnosis of active AD, according to Hanfin and Rajka criteria.

Investigator global assessment (IGA) score of ≥ 3 (on a scale of 0 to 4, in which three is moderate and four is severe) at Screening and Baseline.

AD involvement of ≥ 10% body surface area (BSA) at Screening and Baseline.

Disqualifiers

History or other evidence of severe illness or any other conditions such as psychiatric illness, severe depression or previous history of suicidal attempt in past 10 years that would render the participant, in the opinion of the Investigator, unsuitable for the study.

Active, chronic or acute infection requiring systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the Baseline.

Participant has a current diagnosis of other active skin disease (e.g., psoriasis or lupus erythematosus) or skin infection (bacterial, fungal, or viral) that may affect the evaluation of AD or would interfere with the study assessments based on the Investigator's judgement.

Participant has history of significant flares of AD within 4 weeks prior to screening, in the opinion of the investigator.

Trial design

Treatments tested in this trial

  • Camoteskimab
  • Placebo

Treatment groups

280 Participants
are divided into 4 treatment groups

Locations

85
Bulgaria
Medical Center Medconsult Burgas EOOD Burgas Bulgaria
Medical Center Kazanlak EOOD Kazanlak Bulgaria
Medical Center Medconsult Pleven-Lovech Branch Lovech Bulgaria
Medical Center Medconsult Pleven OOD Pleven Bulgaria

Sponsors and collaborators

Apollo Therapeutics Ltd

Lead sponsor