Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn's Disease
Public ClinicalTrials.gov record NCT03395184. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.
Study identification
- NCT ID
- NCT03395184
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 244 participants
Conditions and interventions
Conditions
Interventions
- PF-06651600 Placebo Drug
- PF-06651600 Drug
- Placebo PF-06700841 Drug
- PF-06700841 Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 2, 2018 (Actual)
- Primary completion
- Oct 19, 2023 (Actual)
- Completion
- Oct 19, 2023 (Actual)
- Last update posted
- Oct 30, 2024
2018 – 2023
United States locations
- U.S. sites
- 57
- U.S. states
- 14
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Dothan Surgery Center | Dothan | Alabama | 36301 | — |
| Gut P.C., dba Digestive Health Specialists of the Southeast | Dothan | Alabama | 36305 | — |
| Brighton Surgical Center | Beverly Hills | California | 90210 | — |
| Entertainment Medical Group | Los Angeles | California | 90036 | — |
| Gastrointestinal Biosciences Clinical Trials, LLC | Los Angeles | California | 90067 | — |
| Stanford Medicine Outpatient Center - Digestive Health Center | Redwood City | California | 94063 | — |
| Front Range Endoscopy Center | Colorado Springs | Colorado | 80903 | — |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | 80907 | — |
| Gastro Florida | Clearwater | Florida | 33756-3839 | — |
| Gastro Florida | Clearwater | Florida | 33756 | — |
| West Coast Endoscopy Center | Clearwater | Florida | 33756 | — |
| Gastro Florida | Clearwater | Florida | 33762 | — |
| UF Health Jacksonville - Gastroenterology Emerson | Jacksonville | Florida | 32207 | — |
| Millenia Surgery Center | Orlando | Florida | 32811 | — |
| HMD Research LLC | Orlando | Florida | 32819 | — |
| Treasure Valley Medical Research | Boise | Idaho | 83706 | — |
| WestGlen Gastrointestinal Consultants, P.A. | Shawnee Mission | Kansas | 66217 | — |
| Chevy Chase Endoscopy Center | Chevy Chase | Maryland | 20815 | — |
| MGG Group Co., Inc., Chevy Chase Clinical Research | Chevy Chase | Maryland | 20815 | — |
| Capitol Research | Rockville | Maryland | 20850 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| Mass Eye and Ear, Longwood | Boston | Massachusetts | 02115 | — |
| Brigham and Women's Hospital | Chestnut Hill | Massachusetts | 02467 | — |
| Clinical Research Institute of Michigan, LLC | Chesterfield | Michigan | 48047 | — |
| Eastside Endoscopy Center | Macomb | Michigan | 48044 | — |
| Weill Cornell Medical College - New York Presbyterian Hospital | New York | New York | 10021 | — |
| Weill Cornell Medical College | New York | New York | 10021 | — |
| New York Presbyterian Hospital - Weill Cornell Medical College (Colonoscopy) | New York | New York | 10065 | — |
| New York Presbyterian Hospital - Weill Cornell Medical College Investigational Pharmacy | New York | New York | 10065 | — |
| Weill Cornell Medical College - New York Presbyterian Hospital (Endoscopy Suite) | New York | New York | 10065 | — |
| Weill Cornell Medical College - New York Presbyterian Hospital | New York | New York | 10065 | — |
| DiGiovanna Institute for Medical Education And Research | North Massapequa | New York | 11758-1853 | — |
| UNC Hospitals | Chapel Hill | North Carolina | 27514 | — |
| UNC Hospitals Endoscopy Center at Meadowmont | Chapel Hill | North Carolina | 27517 | — |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| UNC GI Procedures Hillsborough | Hillsborough | North Carolina | 27278 | — |
| Gastroenterology Associates of the Piedmont, PA | Winston-Salem | North Carolina | 27103 | — |
| PMG Research of Winston-Salem, LLC | Winston-Salem | North Carolina | 27103 | — |
| Holston Medical Group | Kingsport | Tennessee | 37660 | — |
| Holston Valley Surgery Center | Kingsport | Tennessee | 37660 | — |
| Vanderbilt GI Endoscopy Lab at One Hundred Oaks | Nashville | Tennessee | 37204 | — |
| Vanderbilt Inflammatory Bowel Disease Clinic | Nashville | Tennessee | 37204 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212-1375 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212-1610 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232-5543 | — |
| Vanderbilt Inflammatory Bowel Disease Clinic | Nashville | Tennessee | 37232 | — |
| First Street Hospital | Bellaire | Texas | 77401 | — |
| First Street Surgical Center | Bellaire | Texas | 77401 | — |
| Hermann Drive Surgical Hospital | Houston | Texas | 77004 | — |
| Pearland Surgery Center | Houston | Texas | 77047 | — |
| GI Alliance | Southlake | Texas | 76092 | — |
| Lonestar Endoscopy, LLP | Southlake | Texas | 76092 | — |
| Texas Digestive Disease Consultants (Administrative, Regulatory) | Southlake | Texas | 76092 | — |
| Gastroenterology Associates of Northern VA | Fairfax | Virginia | 22031 | — |
| Gastroenterology Associates of Northern Virginia | Fairfax | Virginia | 22031 | — |
| Verity Research, Inc. | Fairfax | Virginia | 22031 | — |
| Blue Ridge Medical Research | Lynchburg | Virginia | 24502 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 138 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03395184, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 30, 2024 · Synced Oct 18, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03395184 live on ClinicalTrials.gov.