A Study to Evaluate the Safety and Efficacy of PF-06650833, PF-06700841, and PF 06826647 in Adults With Hidradenitis Suppurativa
NCT04092452
Last updated date
ABOUT THIS STUDY
This is a study with 3 kinase inhibitors (PF 06650833, PF 06700841 and PF 06826647) in
participants with moderate to severe HS. The study will have a maximum duration of
approximately 26 weeks. This includes an up to 6-week Screening Period, a 16 week Dosing
Period and a 4 week Follow up Period.
Study Location
Keck School of Medicine of University of Southern California
Los Angeles, California, 90033, United States
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Acne Inversa
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- male or female participants, between 18-75, with a diagnosis of moderate to severe Hidradenitis Suppurativa
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- History of human immunodeficiency virus (HIV) or positive HIV serology at screening,
- Infected with hepatitis B or hepatitis C viruses.
- Have evidence of active or latent or inadequately treated infection with Mycobacterium
tuberculosis (TB)
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Acne InversaA Study to Evaluate the Safety and Efficacy of PF-06650833, PF-06700841, and PF 06826647 in Adults With Hidradenitis Suppurativa
NCT04092452
- Los Angeles, California
- Los Angeles, California
- Bridgeport, Connecticut
- Shelton, Connecticut
- Pembroke Pines, Florida
- Sandy Springs, Georgia
- Fremont, California
- Long Beach, California
- Santa Monica, California
- Largo, Florida
- Miami, Florida
- North Miami Beach, Florida
- Orange Park, Florida
- Ormond Beach, Florida
- Tampa, Florida
- Tampa, Florida
- Newnan, Georgia
- Skokie, Illinois
- Skokie, Illinois
- Indianapolis, Indiana
- Boston, Massachusetts
- Boston, Massachusetts
- Troy, Michigan
- Saint Joseph, Missouri
- Saint Louis, Missouri
- Omaha, Nebraska
- Tulsa, Oklahoma
- Philadelphia, Pennsylvania
- Arlington, Texas
- Pflugerville, Texas
- Richmond, Virginia
- Richmond, Virginia
- Bellevue, Washington
- Seattle, Washington
- Phillip, Australian Capital Territory
- Woolloongabba, Queensland
- Carlton, Victoria
- East Melbourne, Victoria
- Barrie, Ontario
- London, Ontario
- Peterborough, Ontario
- Richmond Hill, Ontario
- Quebec,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | |||||
|---|---|---|---|---|---|
| Brief Title ICMJE | A Study to Evaluate the Safety and Efficacy of PF-06650833, PF-06700841, and PF 06826647 in Adults With Hidradenitis Suppurativa | ||||
| Official Title ICMJE | A PHASE 2A, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 16-WEEK STUDY EVALUATING THE SAFETY AND EFFICACY OF PF-06650833, PF-06700841, AND PF-06826647 IN ADULTS WITH MODERATE TO SEVERE HIDRADENITIS SUPPURATIVA | ||||
| Brief Summary | This is a study with 3 kinase inhibitors (PF 06650833, PF 06700841 and PF 06826647) in participants with moderate to severe HS. The study will have a maximum duration of approximately 26 weeks. This includes an up to 6-week Screening Period, a 16 week Dosing Period and a 4 week Follow up Period. | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: The treatment period is a parallel design Masking: Triple (Participant, Investigator, Outcomes Assessor)Primary Purpose: Treatment | ||||
| Condition ICMJE | Acne Inversa | ||||
| Intervention ICMJE |
| ||||
| Study Arms ICMJE |
| ||||
| Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 192 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | October 16, 2021 | ||||
| Estimated Primary Completion Date | September 18, 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||
| Sex/Gender ICMJE |
| ||||
| Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
| ||||
| Listed Location Countries ICMJE | Australia, Canada, United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04092452 | ||||
| Other Study ID Numbers ICMJE | C2501007 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
| ||||
| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Pfizer | ||||
| Study Sponsor ICMJE | Pfizer | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Pfizer | ||||
| Verification Date | June 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||