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Trial record 1 of 1 for:    B7931022 | Recruiting Studies | atopic dermatitis | Industry
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Dose Ranging Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of PF-06700841 Topical Cream in Participants With Mild or Moderate Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT03903822
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
This study is being conducted to provide data on efficacy, safety, tolerability and PK of multiple topical formulation concentrations of PF-06700841 topical cream in the treatment of mild to moderate atopic dermatitis (AD). The study is intended to enable selection of the dose and dosing regimen (once daily [QD] vs twice daily [BID] application) for the future clinical development of topical PF-06700841.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: PF-06700841 Drug: Vehicle (Placebo) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 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 THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06700841 CREAM APPLIED ONCE OR TWICE DAILY FOR 6 WEEKS IN PARTICIPANTS WITH MILD OR MODERATE ATOPIC DERMATITIS
Actual Study Start Date : May 13, 2019
Estimated Primary Completion Date : May 12, 2020
Estimated Study Completion Date : May 12, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
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 QD
Vehicle cream applied once daily (QD)
Drug: Vehicle (Placebo)
Vehicle topical cream

Placebo Comparator: Vehicle cream BID
Vehicle cream applied twice daily (BID)
Drug: Vehicle (Placebo)
Vehicle topical cream




Primary Outcome Measures :
  1. Percent change from baseline in Eczema Area and Severity Index at Week 6 [ Time Frame: Day 1 to Week 6 ]

Secondary Outcome Measures :
  1. Proportion of participants achieving Investigator's Global Assessment (IGA) score of clear (0) or almost clear (1) and a reduction of 2 or more points [ Time Frame: Week 6 ]
  2. Change from baseline in EASI total score [ Time Frame: Day 1 to Week 6 ]
  3. Proportion of participants achieving reduction in weekly averages of Peak Pruritus Numerical Scale (PP-NRS) by 2 or more more points [ Time Frame: Week 1, 2, 3, 4, 5, and 6 ]
  4. Percent change in affected Body Surface Area (BSA) [ Time Frame: Day 1 to Week 6 ]
  5. Proportion of participants achieving EASI-75 [ Time Frame: Day 1 to Week 6 ]
  6. Incidence of treatment-emergent adverse events [ Time Frame: Day 1 to Week 6 ]
  7. Number of participants with clinically significant change from baseline in clinical laboratory test results [ Time Frame: Day 1 to Week 6 ]
  8. Number of participants with clinically significant changes from baseline in ECG parameters [ Time Frame: Day 1 to Week 6 ]
  9. Number of participants with clinically significant change from baseline in vital signs [ Time Frame: Day 1 to Week 6 ]
  10. Number of participants with each severity grade in local tolerability assessments [ Time Frame: Day 1 to Week 6 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of Atopic Dermatitis for at least 3 months
  • Investigator's Global Assessment (IGA) Score of 2 or 3
  • Eczema Area Severity Index (EASI) score of 3-21
  • Body Surface Area (BSA) of 2-20%
  • Peak pruritus-Numerical Rating Scale (PPNRS) of Grade 2 or more

Exclusion Criteria:

  • Other forms of dermatological diseases (other than atopic dermatitis)
  • Fitzpatrick skin type score greater than 5
  • Clinically significant abnormal ECG, vital signs, and laboratory values
  • Infection with HBV, HCV, herpes zoster or 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): NCT03903822


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03903822     History of Changes
Other Study ID Numbers: B7931022
2018-003050-24 ( EudraCT Number )
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
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:
Mild-to-Moderate Atopic Dermatitis
topical

Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases