Value through Innovation27 July 2016

Clinical Study Results

  • Doramapimod - Healthy
    Clinical Study Number 1175.1
    Study Indication Healthy
    Product Doramapimod
    Generic Name Doramapimod
    Lab Code
    Clinical Phase Ia
    Study Title

    Safety, pharmacokinetics and pharmacodynamics of single rising doses (1, 4, 15, 50, 100, 200, 400, and 600 mg) oral BIRB 796 BS in healthy human subjects. A placebo controlled, randomised study, double blinded at each dose level

    Study Document Trial synopsis 1175.1 english
  • Doramapimod - Healthy
    Clinical Study Number 1175.3
    Study Indication Healthy
    Product Doramapimod
    Generic Name Doramapimod
    Lab Code
    Clinical Phase Ia
    Study Title

    Safety, pharmacokinetics and pharmacodynamics of BIRB 796 BS tablets (50, 150, 300 and 600 mg) administered orally to healthy human subjects once daily for 7 days. A placebo controlled, randomised, double blinded study.

    Study Document Trial synopsis 1175.3 english
  • Doramapimod - Healthy
    Clinical Study Number 1175.4
    Study Indication Healthy
    Product Doramapimod
    Generic Name Doramapimod
    Lab Code
    Clinical Phase I
    Study Title

    The effect of single oral dose BIRB 796 BS (50 and 600 mg) on endotoxin-induced inflammatory responses in healthy human subjects. A placebo-controlled, randomised, parallel, double-blinded study.

    Study Document Trial synopsis 1175.4_CO english
  • Doramapimod - Healthy
    Clinical Study Number 1175.6
    Study Indication Healthy
    Product Doramapimod
    Generic Name Doramapimod
    Lab Code
    Clinical Phase I
    Study Title

    A phase I single oral dose (100 mg) trial to characterize the excretion balance of 14c-radiolabeled BIRB 796 BS and to determine its metabolites in normal male subjects

    Study Document Trial synopsis 1175.6_CO english
  • Doramapimod - Psoriasis
    Clinical Study Number 1175.10
    Study Indication Psoriasis
    Product Doramapimod
    Generic Name Doramapimod
    Lab Code
    Clinical Phase IIa
    Study Title

    Phase ll, Randomized, Double-blind, Placebo Controlled, Multicenter, Four Week Trial of BIRB 796 BS 5, 10, 20 and 30 mg Oral Tablets Versus Placebo Administered BID in Patients with Moderate to Severe Plaque-Type Psoriasis

    Study Document Trial synopsis 1175.10 english
  • Doramapimod - Arthritis, Rheumatoid
    Clinical Study Number 1175.11
    Study Indication Arthritis, Rheumatoid
    Product Doramapimod
    Generic Name Doramapimod
    Lab Code
    Clinical Phase IIa
    Study Title

    A randomised, parallel, double-blind, placebo-controlled study to investigate efficacy and safety of different doses (5, 10, 20 and 30 mg) of BIRB 796 BS administered twice a day orally over 4 weeks in patients with active Rheumatoid Arthritis who have failed at least one DMARD

    Study Document Trial synopsis 1175.11 english
  • Doramapimod - Crohn Disease
    Clinical Study Number 1175.12
    Study Indication Crohn Disease
    Product Doramapimod
    Generic Name Doramapimod
    Lab Code
    Clinical Phase IIa
    Study Title

    A randomised, double-blind, placebo-controlled, four parallel groups, dose finding study of BIRB 796 BS (10, 20 and 30 mg) administered twice a day orally over 8 weeks in patients with moderate to servere Crohn´s disease followed by a 18 weeks treatment extension in patients with Clinical Remission or Clinical Response after 8 weeks treatment with the respective dose of BIRB 796 BS

    Study Document Trial synopsis 1175.12 english Trial synopsis 1175.12_ext english
  • Doramapimod - Healthy
    Clinical Study Number 1175.14
    Study Indication Healthy
    Product Doramapimod
    Generic Name Doramapimod
    Lab Code
    Clinical Phase I
    Study Title

    Safety and pharmacokinetics of BIRB 796 BS tablets administered twice daily orally (total daily dose 30 and 60 mg) to healthy human male subjects for 14 days. A double-blind, placebo-controlled, parallel group study.

    Study Document Trial synopsis 1175.14_CO english
  • Doramapimod - Healthy
    Clinical Study Number 1175.17
    Study Indication Healthy
    Product Doramapimod
    Generic Name Doramapimod
    Lab Code
    Clinical Phase I
    Study Title

    An open label, randomised, crossover study of the bioavailability of oral BIRB 796 BS tablets (30 mg single dose) with and without administration of oral pantoprazole in healthy male volunteers to assess the effect of gastric pH on absorption of BIRB 796 BS.

    Study Document Trial synopsis 1175.17_CO english
  • Doramapimod - Arthritis, Rheumatoid
    Clinical Study Number 1175.18
    Study Indication Arthritis, Rheumatoid
    Product Doramapimod
    Generic Name Doramapimod
    Lab Code
    Clinical Phase II
    Study Title

    A 12 week double-blind randomised, placebo-controlled trial to investigate efficacy, safety and pharmacokinetics of BIRB 796 BS tablets at doses of 50 and 70 mg administered twice daily in patients with active rheumatoid arthritis who have failed at least one DMARD

    Study Document Trial synopsis 1175.18 english
  • Doramapimod - Healthy
    Clinical Study Number 1175.21
    Study Indication Healthy
    Product Doramapimod
    Generic Name Doramapimod
    Lab Code
    Clinical Phase I
    Study Title

    Safety and pharmacokinetics of BIRB 796 BS tablets administered twice daily orally (total daily dose 90,120,150 or 180 mg) to healthy human subjects for 14 days. A double-blind, placebo-controlled study in parallel groups for the lower two dose levels then dose escalation for 2 highest dose levels.

    Study Document Trial synopsis 1175.21_CO english

Clinical Trial Registry and structured study results. Find here protocol information for all clinical study types.

European Trial Register of EU studies.