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

  • Autoimmune Disorder
  • Atopic Dermatitis
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:

Not yet recruiting

This study runs in
N/A
Trial Identifier:

NCT06863961 2024-515494-95-00 CS45570

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Study Summary

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

      Hoffmann-La Roche Sponsor
      Phase 2 Phase
      NCT06863961, CS45570, 2024-515494-95-00 Trial Identifier
      RO7790121, Placebo Treatments
      Atopic Dermatitis Condition
      Official Title

      A Phase II, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of RO7790121 in Patients With Moderate to Severe Atopic Dermatitis

      Eligibility Criteria

      gender
      All Gender
      age
      ≥18 Years Age
      healthy-volunteers
      No Healthy Volunteers
      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

      For the latest version of this information please go to www.forpatients.roche.com

       

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