EUCTR2016-000420-26-PLActive, not recruitingPhase 1
A MULTICENTER, SUBJECT-BLIND, INVESTIGATOR-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY, SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF AN IV LOADING DOSE FOLLOWED BY SC ADMINISTRATION OF BIMEKIZUMAB (UCB4940) IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS
CB Biopharma SPR0 sites60 target enrollmentStarted: February 1, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •-Subject has a diagnosis of Ulcerative Colitis (UC) confirmed (at least 90 days prior to Visit 1a) by clinical, endoscopic, and histologic evidence
- •- Subject has a Mayo endoscopy subscore >=2
- •- Subject has a Mayo rectal bleeding subscore >=1
- •- Subject has moderate to severe active UC - Total Mayo score 6 to 12 within 10 (±4) days prior to Visit 2 (Week 0)
- •- Subject has responded inadequately to convention therapy for UC
- •- Subjets may have received treamtment with 1 biological therapy or a calcineurin inhibitor
- •- Woman with childbearing potential must be either postmenopausal, permanently sterilized or willing
- •to use at least 1 highly effective method of contraception in addition to a barrier method
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
Exclusion Criteria
- •- Subject who has had a resective colonic surgery, or has an ostomy or ileoanal pouch or is planning any resection while enrolled in the study
- •- Subject with current diagnosis of Crohn´s Disease (CD) or indeterminant colitis or acute diverticulitis based on medical history
- •- Subject has an extension of disease limited to ulcerative proctitis (disease extension) <15cm from the anal verge
- •- Subject requiring immediate surgical, endoscopic or radiological intervention due to toxic megacolo intraabdominal or perianal abscess
Investigators
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A SINGLE-CENTER, RANDOMIZED, INVESTIGATOR/SUBJECT-BLIND, ADAPTIVE SINGLE-ASCENDING-DOSE (SAD), PLACEBO-CONTROLLED, PARALLEL STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS (INCLUDING THE EFFECT OF FOOD AND THE EFFECT OF ITRACONAZOLE ON THE PHARMACOKINETICS OF A SINGLE ORAL DOSE OF RO7034067), AND PHARMACODYNAMICS OF RO7034067 FOLLOWING ORAL ADMINISTRATION IN HEALTHY SUBJECTSNL-OMON42781F. Hoffmann-La Roche Ltd93