Eine Studie zur Beurteilung der Wirksamkeit, Sicherheit und Pharmakokinetik von UTTR1147A im Vergleich zu Placebo und Vedolizumab bei Teilnehmenden mit mittelschwerer bis schwerer Colitis ulcerosa (CU)

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative Colitis (UC)

  • Autoimmunerkrankung
  • Chronisch-entzündliche Darmerkrankung (CED)
  • Colitis Ulcerosa
Bitte beachten Sie, dass der Rekrutierungsstatus der Studie an Ihrem Standort vom Gesamtstatus der Studie abweichen kann, da einige Studienzentren früher rekrutieren als andere.
Status der Studie:

Abgeschlossen

Diese Studie läuft in
Städte
  • Berlin
  • Dresden
  • Ludwigshafen am Rhein
  • Lübeck
  • Ulm
Studien-ID:

NCT03558152 2017-002350-36 GA39925

      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 phase 2, randomized, double-blind, placebo-controlled, parallel-group clinical trial – was done to study “efmarodocokin alfa”, a new medicine for the treatment of patients with ulcerative colitis (UC). This study compared how well efmarodocokin alfa works in comparison to vedolizumab and placebo – when given to people with UC. One hundred and ninety-five people took part at 71 study centers in 16 countries.

      Genentech, Inc. (A part of F. Hoffmann-La Roche Ltd., Switzerland) Sponsor
      Phase 2 Phase
      NCT03558152, GA39925, 2017-002350-36 Studien-ID
      efmarodocokin alfa Treatments
      Ulcerative Colitis Condition
      Official Title

      A Phase II, Randomized, Parallel-Group, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study To Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and Compared With Vedolizumab in Patients With Moderate to Severe Ulcerative Colitis

      Einschlusskriterien

      All Gender
      ≥ 18 Years & ≤ 80 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Diagnosis of UC
      • Confirmation of moderately to severely active UC, defined by the Mayo Clinic Score
      • Inadequate response, loss of response, or intolerance to prior immunosuppressant treatment (i.e., azathioprine, 6-mercaptopurine, methotrexate, or tumor necrosis factor [TNF] inhibitors [maximum of 2 prior TNF inhibitors]) and/or corticosteroid treatment
      • Use of highly effective contraception as defined by the protocol
      Exclusion Criteria
      • History of psoriasis or psoriatic arthritis; any other inflammatory skin disorders requiring oral corticosteroids, immunosuppressants, or biological therapy within the previous year; or primary sclerosing cholangitis
      • History of cancer as defined by the protocol
      • Significant uncontrolled comorbidity, such as cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders (excluding UC)
      • Prior extensive colonic resection, subtotal or total colectomy, or proctocolectomy, or planned surgery for UC
      • Diagnosis of indeterminate colitis or granulomatous (Crohn's) colitis or toxic megacolon within 12 months prior to screening
      • Suspicion of ischemic colitis, radiation colitis, or microscopic colitis
      • Current fistula or history of fistula, pericolonic abscess and stricture (stenosis) of the colon
      • History or current evidence of unresectable colonic mucosal dysplasia or history of high-grade colonic mucosal dysplasia
      • Prior treatment with UTTR1147A
      • Prior treatment with vedolizumab, etrolizumab, natalizumab, efalizumab, or any other anti-integrin agents
      • Prior treatment with rituximab
      • Use of prohibited therapies, as defined by the protocol, prior to randomization
      • Congenital or acquired immune deficiency
      • Evidence or treatment of infections or history of infections, as defined by the protocol

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