Eine Studie zur Beurteilung der Wirksamkeit und Sicherheit von MSTT1041A bei Teilnehmenden mit mittelschwerer bis schwerer atopischer Dermatitis

A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Moderate to Severe Atopic Dermatitis

  • Autoimmunerkrankung
  • Atopic Dermatitis
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Status der Studie:

Abgeschlossen

Diese Studie läuft in
Stadt
  • Münster
Studien-ID:

NCT03747575 2018-003429-27 GS40965

      Studienzentren finden

      Die folgenden Informationen stammen aus der öffentlich zugänglichen Website ClinicalTrials.gov und werden für Laien bearbeitet.

      Die folgenden Informationen stammen aus der öffentlich zugänglichen Website ClinicalTrials.gov und werden nicht geändert.

      Results Disclaimer

      Studienzusammenfassung

      This study will assess the efficacy and safety of MSTT1041A (astegolimab) in participants with moderate to severe atopic dermatitis (AD). The study consists of a screening period, a 16-week treatment period, and an 8-week follow-up period.

      Genentech, Inc. Sponsor
      Phase 2 Phase
      NCT03747575, GS40965, 2018-003429-27 Studien-ID
      MSTT1041A, Placebo Treatments
      Atopic Dermatitis Condition
      Official Title

      A Phase II, Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Assess the Efficacy and Safety of MSTT1041A in Patients With Moderate to Severe Atopic Dermatitis

      Einschlusskriterien

      All Gender
      ≥ 18 Years & ≤ 75 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Ability to comply with the study protocol
      • Chronic AD that has been present for at least 3 years before the screening visit
      • Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications (medications or treatments applied directly to part of the body) or for whom topical treatments are otherwise medically inadvisable
      Exclusion Criteria
      • Prior treatment with MSTT1041A
      • Treatment with any investigational therapy (with the exception of biologics) within 8 weeks or within 5 half-lives whichever is longer, before screening
      • Treatment with any cell-depleting agents within 6 months before screening, or until lymphocyte count returns to normal, whichever is longer
      • Treatment with other biologics within 3 months or 5 half-lives before screening, whichever is longer
      • Comorbid conditions that may interfere with evaluation of investigational medicinal product
      • History or evidence of substance abuse that would pose a risk to participant safety, interfere with the conduct of the study, have an impact on the study results, or affect the participant's ability to participate in the study
      • History of anaphylaxis, hypersensitivity to a biologic agent, or known hypersensitivity to any component of the MSTT1041A or placebo injection
      • Planned surgical intervention during the course of the study
      • Pregnant or breastfeeding, or intending to become pregnant during the study
      • Participant who is a member of the investigational team or his/her immediate family

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