Study to Evaluate the Efficacy and Safety of PF-06480605 in Adult Participants With Moderate to Severe Crohn's Disease
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment Group 1 PF-06480605 150 mg |
Drug: Investigational Product
PF-06480605 150 mg
|
| Placebo Comparator: Treatment Group 2 Placebo |
Drug: Placebo
Placebo
|
Outcome Measures
Primary Outcome Measures
- Proportion of participants with endoscopic response 50 [Week 14]
Endoscopy response 50 (SES-CD50) is defined as a reduction from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at least 50% or more. SES-CD score assesses the presence of ulcers, the percentage of ulcerated surface, the percentage of affected surface, and the presence of narrowing using scales ranging from 0 to 3 in each following bowel segment: Ileum, right colon, transverse colon, left colon, rectum. The score ranges from 0 to 60 with higher score indicating more severe disease.
Secondary Outcome Measures
- Proportion of participants with a Crohn's Disease Activity Index (CDAI) clinical remission [Week 14]
Clinical remission is defined as CDAI < 150. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
- Proportion of participants achieving endoscopic remission [Week 14]
Endoscopic remission is defined as SES-CD < 4 and at least 2-point reduction versus Baseline and no individual subscore > 1
- Proportion of participants achieving endoscopic mucosal healing [Week 14]
Endoscopic mucosal healing defined as complete absence of ulcers in SES-CD
- The proportion of participants with Inflammatory Bowel Disease Questioners (IBDQ) total score ≥170 [Week 14]
Inflammatory Bowel Disease Questionnaire (IBDQ) score ranges from 32 to 224. A higher score indicates better quality of life. A score of at least 170 corresponds to clinical remission.
- Proportion of participants achieving endoscopic response [Week 52]
Endoscopic response defined as improvement of SES-CD score at least 50% from baseline
- Proportion of participants with a CDAI clinical remission [Week 52]
Clinical remission is defined as CDAI < 150. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
- Proportion of participants achieving endoscopic remission [Week 52]
Endoscopic remission is defined as SES-CD < 4 and at least 2-point reduction versus Baseline and no individual subscore > 1
- Proportion of participants achieving endoscopic mucosal healing [Week 52]
Endoscopic mucosal healing defined as complete absence of ulcers in SES-CD
- Proportion of participants with a CDAI clinical remission [up to week 52]
CDAI < 150 overtime during induction treatment period
- Proportion of participants with a CDAI clinical response [Up to week 52]
As defined by a decrease from baseline in CDAI score of at least 100 points or more
- Proportion of participants achieving Patient Reported Outcome 2 (PRO2) clinical response [Up to week 52]
PRO2 clinical response is define by improvement in number of liquid/soft stool frequency and abdominal pain score at least 30% from baseline
- Proportion of participants achieving PRO2 clinical remission [Up to week 52]
PRO2 clinical remission is defined as SF≤2.5 and AP≤1
- Incidence of AEs or SAEs including events leading to withdrawal due to abnormalities in laboratory, vital signs, and ECG. [up to week 52]
- Incidence of development of severe and serious infections [Up to week 52]
Eligibility Criteria
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;
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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;
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Strictures or stenosis with obstructive symptoms;
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Short bowel syndrome;
-
History of bowel perforation requiring surgical intervention within the past 12 months prior to baseline;
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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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- B7541009
- 2022-001259-18