Clinical trial NCT05471492: Study to Evaluate the Efficacy and Safety of PF-06480605 in Adult Participants With Moderate to Severe Crohn's Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Crohn Disease
Keywords: Crohn Disease, PF-06480605, SES-CD, CDAI,
Lead sponsor: Telavant, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2022-07-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of two groups in parallel for the duration of the study
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, UC, or clinical findings suggestive of UC;
* Presence of active (draining) fistulae or intra-abdominal or perineal abscesses;
* Strictures or stenosis with obstructive symptoms;
* Short bowel syndrome;
* 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.

Primary outcomes:
measure: Proportion of participants with endoscopic response 50
timeFrame: Week 14
Secondary outcomes:
measure: Proportion of participants with a Crohn's Disease Activity Index (CDAI) clinical remission
timeFrame: Week 14
measure: Proportion of participants achieving endoscopic remission
timeFrame: Week 14
measure: Proportion of participants achieving endoscopic mucosal healing
timeFrame: Week 14
measure: The proportion of participants with Inflammatory Bowel Disease Questioners (IBDQ) total score ≥170
timeFrame: Week 14
measure: Proportion of participants achieving endoscopic response
timeFrame: Week 52
measure: Proportion of participants with a CDAI clinical remission
timeFrame: Week 52
measure: Proportion of participants achieving endoscopic remission
timeFrame: Week 52
measure: Proportion of participants achieving endoscopic mucosal healing
timeFrame: Week 52
measure: Proportion of participants with a CDAI clinical remission
timeFrame: up to week 52
measure: Proportion of participants with a CDAI clinical response
timeFrame: Up to week 52
measure: Proportion of participants achieving Patient Reported Outcome 2 (PRO2) clinical response
timeFrame: Up to week 52
measure: Proportion of participants achieving PRO2 clinical remission
timeFrame: Up to week 52
measure: Incidence of AEs or SAEs including events leading to withdrawal due to abnormalities in laboratory, vital signs, and ECG.
timeFrame: up to week 52
measure: Incidence of development of severe and serious infections
timeFrame: Up to week 52
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: