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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03850483
Recruitment Status : Active, not recruiting
First Posted : February 21, 2019
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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 240 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 294 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 : April 21, 2021
Estimated Study Completion Date : April 21, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in Psoriasis Area and Severity Index (PASI) score. [ Time Frame: Day 1 to Week 12 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Percentage of participants achieving PASI 75 [ Time Frame: Day 1 to Week 1, 2, 4, 6, 8, 10, 12, 14, 16 ]
  3. Percentage change from baseline in PASI score [ Time Frame: Day 1 to Week 1, 2, 4, 6, 8, 10, 12, 14, 16 ]
  4. 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 ]
  5. Absolute Peak Pruritus Numerical Rating Scale score [ Time Frame: Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16 ]
  6. Change from baseline in Psoriasis Symptom Inventory score [ Time Frame: Day 1 to Week 1, 2, 4, 6, 8, 10, 12, 14, 16 ]
  7. 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 ]
  8. Number of participants with adverse events (AEs) by seriousness and relationship to treatment [ Time Frame: Day 1 to Week 16 ]
  9. Number of participants with change from baseline in laboratory test results [ Time Frame: Day 1 to Week 16 ]
  10. Number of participants with clinically relevant changes from baseline in electrocardiogram parameters [ Time Frame: Day 1 to Week 12 ]
  11. Number of participants with clinically relevant changes from baseline in vital signs [ Time Frame: Day 1 to Week 16 ]
  12. Number of participants with each severity grade in skin tolerability assessment at the sites of IP application [ Time Frame: Day 1 to Week 16 ]
  13. Change from baseline in PASI score [ Time Frame: Day 1 to Week 1, 2, 4, 6, 8, 10, 14, 16 ]
  14. 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 ]
  15. Psoriasis Symptom Inventory score [ Time Frame: Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16 ]

Eligibility Criteria
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Information from the National Library of Medicine

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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
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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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: June 18, 2020
Last Verified: June 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

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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:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases