Efficacy, Safety and Tolerability of PF-06687234 as Add-on Therapy to Infliximab in Active UC Subjects Not in Remission.
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|ClinicalTrials.gov Identifier: NCT03269695|
Recruitment Status : Recruiting
First Posted : September 1, 2017
Last Update Posted : May 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Drug: PF-06687234 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||76 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06687234 AS ADD-ON THERAPY TO INFLIXIMAB IN ACTIVE ULCERATIVE COLITIS SUBJECTS WHO ARE NOT IN REMISSION (BUILD UC)|
|Actual Study Start Date :||December 20, 2017|
|Estimated Primary Completion Date :||July 27, 2021|
|Estimated Study Completion Date :||July 27, 2021|
PF-06687234 subcutaneous (SC) weekly (QW) x 12 doses
Other Name: Investigational product
Placebo Comparator: Placebo
PF-06687234 matched Placebo SC QW x 12 doses
Other Name: PF-06687234 matched placebo
- Proportion of subjects in Clinical Remission [ Time Frame: Week 12 ]Clinical remission defined by a modified Mayo Score with an endoscopic subscore less than or equal to 1, stool frequency subscore less than or equal to 1 and rectal bleeding subscore = 0
- Proportion of subjects with endoscopic improvement [ Time Frame: Week 12 ]Endoscopic improvement defined as decrease of 1 point in Mayo endoscopy score or an absolute endoscopy score of 1 or less.
- Mean change from baseline at Week 12 in Geboes histology score [ Time Frame: Baseline, Week 12 ]Mean change from baseline at Week 12 in Geboes score.
- Proportion of subjects with a clinical response [ Time Frame: Week 12 ]Clinical response defined with a decrease from baseline of at least 3 points in total Mayo score with at least 30% change, accompanied by at least one point decrease or absolute score of 0 or 1 in rectal bleeding subscore.
- Proportion of subjects with change from baseline in partial Mayo Score of 2 or less with no individual subscore >1 [ Time Frame: Weeks 2, 4, 6, 8, 12 ]Proportion of subjects with partial Mayo score <=2 with no individual subscore of > 1 at Week 2, 4, 6, 8 and 12
- Serum concentrations of PF 06687234 [ Time Frame: Baseline through Week 12 ]Measure serum concentration of PF-06687234 at baseline, Week 1, 3, 7, 11, 12, and 16
- Incidence of the development of HAFAs and Nabs against PF 06687234. [ Time Frame: Baseline through Week 16 ]Measure HAFA and neutralizing antibody against IL10 at screen, baseline, Week 3, 7, 11, 12, and 16
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03269695
|Contact: Pfizer CT.gov Call Center||1-800-718-1021||ClinicalTrials.gov_Inquiries@pfizer.com|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|