Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

A Study to Assess the Efficacy and Safety of Afimkibart (RO7790121) in Participants With Moderate to Severe Atopic Dermatitis
A Study to Assess the Efficacy and Safety of Afimkibart (RO7790121) in Participants With Moderate to Severe Atopic Dermatitis

NCT06863961

Active Not RecruitingPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Atopic Dermatitis

Interventions: Afimkibart, Placebo

Countries: United States, Brazil, Canada, France, Germany, Italy, Poland, Spain

The purpose of this study is to assess the efficacy and safety of Afimkibart (also known as RO7790121) in participants with moderate to severe atopic dermatitis (AD).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* AD diagnosis confirmed by a dermatologist according to the Hanifin/Rajka criteria at least 1 year prior to screening
* Moderate to severe AD
* At least once daily use of an additive-free, bland emollient for at least 7 days prior to the baseline visit and during the study

Exclusion Criteria:

* Evidence of other skin conditions that would interfere with the assessment of AD, including, but not limited to, for example cutaneous T-cell lymphoma, allergic contact dermatitis
* IV, IM, IL, and oral corticosteroids (inhaled, ophthalmic drops, and nasal corticosteroids are allowed) within 4 weeks of the baseline visit and during the study
* Topical treatment for AD including, but not limited to topical corticosteroids, topical calcineurin Inhibitors, topical PDE-4 inhibitors, , prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea or filaggrin within 7 days prior to the baseline visit and during the study
* Any active infection or other active skin diseases that required treatment with parenteral anti-infectives within 4 weeks or oral anti-infective treatment within 2 weeks prior to baseline
* Acquired or congenital immunodeficiency
* Systemic therapies that are also used in the treatment of AD, including, but not limited to methotrexate, cyclosporine, azathioprine, mycophenolate mofetil within 4 weeks of the baseline visit and during the study
Locations (60)
  • Fremont, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Fort Myers, Florida, United States
  • Tampa, Florida, United States
  • Alpharetta, Georgia, United States
  • Atlanta, Georgia, United States
  • Indianapolis, Indiana, United States
  • New Albany, Indiana, United States
  • Troy, Michigan, United States
  • Minneapolis, Minnesota, United States
  • Hoboken, New Jersey, United States
  • Kew Gardens, New York, United States
  • New York, New York, United States
  • Columbus, Ohio, United States
  • Oklahoma City, Oklahoma, United States
  • Portland, Oregon, United States
  • Camp Hill, Pennsylvania, United States
  • Arlington, Texas, United States
  • Dallas, Texas, United States
  • Dallas, Texas, United States
  • Salvador, Estado de Bahia, Brazil
  • Curitiba, Paraná, Brazil
  • Porto Alegre, Rio Grande do Sul, Brazil
  • Porto Alegre, Rio Grande do Sul, Brazil
  • Botucatu, São Paulo, Brazil
  • Campinas, São Paulo, Brazil
  • Santo Andr, São Paulo, Brazil
  • Sao Jose Rio Preto, São Paulo, Brazil
  • Rio de Janeiro, Brazil
  • + 30 more on CT.gov