Trial record 1 of 1 for:
B7931023 | psoriasis
Dose Ranging Study To Assess Efficacy, Safety and Tolerability Of PF-06700841 Topical Cream In Psoriasis
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03850483 |
|
Recruitment Status :
Recruiting
First Posted : February 21, 2019
Last Update Posted : November 3, 2020
|
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Psoriasis | Drug: PF-06700841 Drug: Vehicle (Placebo) | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 240 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Actual Study Start Date : | April 8, 2019 |
| Estimated Primary Completion Date : | February 21, 2021 |
| Estimated Study Completion Date : | February 21, 2021 |
| Arm | Intervention/treatment |
|---|---|
|
Placebo Comparator: Vehicle cream QD
Vehicle cream applied once daily (QD)
|
Drug: Vehicle (Placebo)
Vehicle topical cream |
|
Experimental: PF-06700841 0.1% cream QD
PF-06700841 0.1% cream applied once daily (QD)
|
Drug: PF-06700841
PF-06700841 topical cream |
|
Experimental: PF-06700841 0.3% cream QD
PF-06700841 0.3% cream applied once daily (QD)
|
Drug: PF-06700841
PF-06700841 topical cream |
|
Experimental: PF-06700841 1% cream QD
PF-06700841 1% cream applied once daily (QD)
|
Drug: PF-06700841
PF-06700841 topical cream |
|
Experimental: PF-06700841 3% cream QD
PF-06700841 3% cream applied once daily (QD)
|
Drug: PF-06700841
PF-06700841 topical cream |
|
Experimental: PF-06700841 0.3% cream BID
PF-06700841 0.3% cream applied twice daily (BID)
|
Drug: PF-06700841
PF-06700841 topical cream |
|
Experimental: PF-06700841 1% cream BID
PF-06700841 1% cream applied twice daily (BID)
|
Drug: PF-06700841
PF-06700841 topical cream |
|
Placebo Comparator: Vehicle cream BID
Vehicle cream applied twice daily (BID)
|
Drug: Vehicle (Placebo)
Vehicle topical cream |
|
Experimental: PF-06700841 3% cream BID
PF-06700841 3% cream applied twice daily (BID)
|
Drug: PF-06700841
PF-06700841 topical cream |
Primary Outcome Measures :
- Change from baseline in Psoriasis Area and Severity Index (PASI) score. [ Time Frame: Day 1 to Week 12 ]
Secondary Outcome Measures :
- Percentage of participants with Physician's Global Assessment (PGA) score clear (0) or almost clear (1) and 2 points improvement. [ Time Frame: Day 1 to Week 12 ]
- Percentage of participants achieving PASI 75 [ Time Frame: Day 1 to Week 1, 2, 4, 6, 8, 10, 12, 14, 16 ]
- Percentage change from baseline in PASI score [ Time Frame: Day 1 to Week 1, 2, 4, 6, 8, 10, 12, 14, 16 ]
- Percentage of participants with PGA score clear (0) or almost clear (1) and 2 points improvement [ Time Frame: Day 1 to Week 1, 2, 4, 6, 8, 10, 14, 16 ]
- Absolute Peak Pruritus Numerical Rating Scale score [ Time Frame: Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16 ]
- Change from baseline in Psoriasis Symptom Inventory score [ Time Frame: Day 1 to Week 1, 2, 4, 6, 8, 10, 12, 14, 16 ]
- The percentage of participants who achieved a Psoriasis Symptom Inventory score of 0 (not at all) or 1 (mild) on every item [ Time Frame: Day 1 to Week 1, 2, 4, 6, 8, 10, 12, 14, 16 ]
- Number of participants with adverse events (AEs) by seriousness and relationship to treatment [ Time Frame: Day 1 to Week 16 ]
- Number of participants with change from baseline in laboratory test results [ Time Frame: Day 1 to Week 16 ]
- Number of participants with clinically relevant changes from baseline in electrocardiogram parameters [ Time Frame: Day 1 to Week 12 ]
- Number of participants with clinically relevant changes from baseline in vital signs [ Time Frame: Day 1 to Week 16 ]
- Number of participants with each severity grade in skin tolerability assessment at the sites of IP application [ Time Frame: Day 1 to Week 16 ]
- Change from baseline in PASI score [ Time Frame: Day 1 to Week 1, 2, 4, 6, 8, 10, 14, 16 ]
- Change from baseline in Absolute Peak Pruritus Numerical Rating Scale score [ Time Frame: Day 1 to Week 1, 2, 4, 6, 8, 10, 12, 14, 16 ]
- Psoriasis Symptom Inventory score [ Time Frame: Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16 ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- plaque psoriasis for 6 months
- PGA score mild or moderate
- body surface area (BSA) 2-15%
Exclusion Criteria:
- other skin conditions that would interfere with the evaluation of psoriasis
- history of herpes zoster or simplex
- Infected with Mycobacterium tuberculosis
Information from the National Library of Medicine
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): NCT03850483
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Locations
Show 79 study locations
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Publications:
Publications:
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT03850483 |
| Other Study ID Numbers: |
B7931023 2018-003051-38 ( EudraCT Number ) |
| First Posted: | February 21, 2019 Key Record Dates |
| Last Update Posted: | November 3, 2020 |
| Last Verified: | November 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Pfizer:
|
psoriasis topical |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases |