Dose Ranging Study To Assess Efficacy, Safety and Tolerability Of PF-06700841 Topical Cream In Psoriasis
NCT03850483
Last updated date
ABOUT THIS STUDY
This is a Phase 2b, randomized, double blind, vehicle controlled, parallel group, multicenter
study in participants with mild to moderate plaque psoriasis. The duration of study
participation will be approximately 22 weeks, including up to a 6 week screening period, 12
week treatment period, and approximately 4 week follow up period. Approximately 280
participants are planned to be randomized into the study.
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.
Psoriasis
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
- plaque psoriasis for 6 months
- PGA score mild or moderate
- body surface area (BSA) 2-15%
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- other skin conditions that would interfere with the evaluation of psoriasis
- history of herpes zoster or simplex
- Infected with Mycobacterium tuberculosis
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Advanced Information
| Descriptive Information | |||||
|---|---|---|---|---|---|
| Brief Title ICMJE | Dose Ranging Study To Assess Efficacy, Safety and Tolerability Of PF-06700841 Topical Cream In Psoriasis | ||||
| Official Title ICMJE | A PHASE 2B, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED, PARALLEL-GROUP, DOSE RANGING STUDY TO ASSESS EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06700841 TOPICAL CREAM APPLIED ONCE OR TWICE DAILY FOR 12 WEEKS IN PARTICIPANTS WITH MILD TO MODERATE CHRONIC PLAQUE PSORIASIS | ||||
| Brief Summary | This is a Phase 2b, randomized, double blind, vehicle controlled, parallel group, multicenter study in participants with mild to moderate plaque psoriasis. The duration of study participation will be approximately 22 weeks, including up to a 6 week screening period, 12 week treatment period, and approximately 4 week follow up period. Approximately 280 participants are planned to be randomized into the study. | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | ||||
| Condition ICMJE | Psoriasis | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Forman SB, Pariser DM, Poulin Y, Vincent MS, Gilbert SA, Kieras EM, Qiu R, Yu D, Papacharalambous J, Tehlirian C, Peeva E. TYK2/JAK1 Inhibitor PF-06700841 in Patients with Plaque Psoriasis: Phase IIa, Randomized, Double-Blind, Placebo-Controlled Trial. J Invest Dermatol. 2020 Apr 18. pii: S0022-202X(20)31379-8. doi: 10.1016/j.jid.2020.03.962. [Epub ahead of print] | ||||
* 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 | 240 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | March 15, 2021 | ||||
| Estimated Primary Completion Date | March 15, 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||
| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Australia, Bulgaria, Canada, Denmark, Germany, Hungary, Japan, Latvia, Poland, United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03850483 | ||||
| Other Study ID Numbers ICMJE | B7931023 2018-003051-38 ( EudraCT Number ) | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
| ||||
| IPD Sharing Statement ICMJE |
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| Responsible Party | Pfizer | ||||
| Study Sponsor ICMJE | Pfizer | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Pfizer | ||||
| Verification Date | October 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||