NCT05471492WithdrawnPhase 2
Study to Evaluate the Efficacy and Safety of PF-06480605 in Adult Participants With Moderate to Severe Crohn's Disease
A PHASE 2A, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY WITH AN OPEN LABEL CHRONIC TREATMENT PERIOD TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF PF-06480605 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE CROHN'S DISEASE
Source: ClinicalTrials.gov · Last updated 19 Oct 2023
Reason given: Trial not started; change in Sponsor, a new trial to be registered by the new Sponsor
Brief summary (registry, in English)
This Phase 2a, multicenter, randomized, double-blind, placebo-controlled study examines subcutaneous dose of PF-06480605 150 mg administered every 4 weeks in participants with moderate to severe active Crohn's Disease to characterize safety, efficacy, pharmacokinetics, and immunogenicity
- Status (registry)
- Withdrawn
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 18 Jul 2022
- Start date
- 30 Jul 2023
- Primary completion date
- 15 Aug 2026
- Lead sponsor
- Telavant, Inc.
- Diseases
- Crohn's disease
- NCT number
- NCT05471492
- EudraCT number
- 2022-001259-18
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of bowel perforation requiring surgical intervention within the past 12 months prior to baseline;
- Previous bowel surgery resulting in an existing stoma. Participants who have a j-pouch are excluded, as a j-pouch can result in a stoma;
- History of bowel surgery within 6 months prior to baseline.
Other illness
- Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, UC, or clinical findings suggestive of UC;
- Short bowel syndrome;
Other
- Presence of active (draining) fistulae or intra-abdominal or perineal abscesses;
- Strictures or stenosis with obstructive symptoms;
Who the study is looking for
- Confirmed diagnosis of ileocolonic or colonic CD with at least 3 months or longer prior to the baseline;
- Central read total SES-CD score of ≥7. For isolated ileal disease, SES-CD total score should be ≥4;
- An average daily liquid/very soft SF ≥4 or daily AP score ≥2.0;
- CDAI between 220 and 450 inclusive;
- Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.