Dermatitis, Atopic Clinical Trial
Official title:
A PHASE 3 RANDOMIZED WITHDRAWAL, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY INVESTIGATING THE EFFICACY AND SAFETY OF PF-04965842 IN SUBJECTS AGED 12 YEARS AND OVER, WITH MODERATE TO SEVERE ATOPIC DERMATITIS WITH THE OPTION OF RESCUE TREATMENT IN FLARING SUBJECTS
B7451014 is a Phase 3 study to investigate PF-04965842 in patients aged 12 years and over with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. Subjects responding well to an initial open-label 12 week treatment of PF-04965842 (200 mg) taken orally once daily (QD) will be identified and randomized in a double-blind manner to receive 200 mg QD PF-04965842, 100 mg QD PF-04965842, or QD placebo. Efficacy and safety of 2 doses of PF-04965842 will be evaluated relative to placebo over 40 weeks. Subjects experiencing significant worsening of their symptoms, i.e., protocol-defined flare, enter 12 weeks rescue treatment and receive 200 mg PF-04965842 together with a marketed topical medicine. Eligible patients will have the option to enter a long-term extension study after completing the initial 12 week treatment, the 12 week rescue treatment, and the 40 week blinded treatment.
Responder criteria for randomization at week 12 are defined as a) achieving an IGA of clear (0) or almost clear (1) (on a 5 point scale), b) a reduction from IGA baseline of 2 or more points, and c) reaching an EASI-75 response compared to baseline. Flare requiring rescue treatment is defined as a loss of at least 50% of the EASI response at Week 12 and an IGA score of 2 or higher. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03563066 -
Effect of Benralizumab in Atopic Dermatitis
|
Phase 2 | |
| Terminated |
NCT04086121 -
A Study to Test the Long-term Safety of BI 655130 in Patients With Atopic Eczema Who Took Part in Study 1368-0032
|
Phase 2 | |
| Recruiting |
NCT04011215 -
Wool Clothing for the Management of Childhood Atopic Dermatitis (DESSINE2)
|
N/A | |
| Completed |
NCT04635072 -
Stabilized Whole Rice Bran (SWRB) for Mild to Moderate Atopic Dermatitis
|
Early Phase 1 | |
| Completed |
NCT02916888 -
A Study Comparing the Quality of Life of Patients in the Treatment of Eczema by Pediatric Generalists and Specialists
|
N/A | |
| Completed |
NCT01945086 -
A Study of Ustekinumab (STELARA®) in Adult Japanese Participants With Severe Atopic Dermatitis
|
Phase 2 | |
| Completed |
NCT00541255 -
A Long-Term Examination of Asthma From Childhood Through Adolescence
|
||
| Terminated |
NCT04990440 -
A Study of Bermekimab for the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis
|
Phase 2 | |
| Completed |
NCT02900131 -
Efficacy, Safety and Dose Finding Trial of Topical Jaungo Application in Atopic Dermatitis Patients
|
Phase 2 | |
| Completed |
NCT03568136 -
Investigation of Efficacy of Secukinumab in Patients With Moderate to Serve Atopic Dermatitis
|
Phase 2 | |
| Recruiting |
NCT01631617 -
Effects of Treatments on Atopic Dermatitis
|
Phase 2 | |
| Completed |
NCT03672383 -
Functional Study to Investigate the Efficacy of a New Medical Device (Modified Diprobase Formulation)
|
N/A | |
| Completed |
NCT03634345 -
Drug Drug Interaction Study Evaluating the Effect of Fluvoxamine or Fluconazole on PK and Safety of PF-04965842.
|
Phase 1 | |
| Enrolling by invitation |
NCT04761978 -
Efficacy and Tolerance of JAK Inhibitors in ATU for Atopic Dermatitis
|
||
| Completed |
NCT03663673 -
Effect of Different Skin Creams on TEWL
|
Phase 1 | |
| Recruiting |
NCT05177744 -
Toxicity of Micro and Nano Plastics Combined With Environmental Contaminants on the Risk of Allergic Disease
|
||
| Completed |
NCT03720470 -
Study Evaluating Efficacy and Safety of PF-04965842 and Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis on Background Topical Therapy
|
Phase 3 | |
| Completed |
NCT02637206 -
Skin Irritation Study of GSK2894512 Cream
|
Phase 1 | |
| Completed |
NCT05544591 -
Evaluation of 611 in Chinese Adults With Moderate to Severe Atopic Dermatitis
|
Phase 2 | |
| Completed |
NCT05094700 -
A Study of a Polymeric Surfactant Technology Cleanser in Sensitive Skin Participants
|
N/A |