Dermatitis, Atopic Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study of Ustekinumab in Adult Japanese Subjects With Severe Atopic Dermatitis
The purpose of this study is to assess the safety and effectiveness of 2 doses of ustekinumab compared with placebo (inactive medication) in adult Japanese participants with severe atopic dermatitis.
This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo-controlled (one of the study medications is inactive), multicenter, parallel group study (each participant group receives different treatments simultaneously). Participants will be randomly assigned in a 1:1:1 ratio to receive either ustekinumab 45 mg, ustekinumab 90 mg, or placebo. The study will consist of a screening period, a 12-week double-blind treatment period, and a 12-week follow-up period. During the double-blind treatment period, participants will receive one subcutaneous injection of study medication at Week 0 and Week 4. Participants will return to the study center for 7 evaluation visits on Weeks 2, 4, 8, 12, 16, 20, and 24. Clinical response will be evaluated by Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), photography, and Dermatology Life Quality Index (DLQI). Participants will record their itch condition twice daily using the participant daily diary from 2 weeks prior to randomization until Week 12. Blood samples will be drawn at time periods during the screening, double-blind treatment, and follow-up periods. Participant safety will be monitored throughout the study. Participants are permitted to use concomitant topical medications, as defined in the protocol and without any increase in dose, from 4 weeks prior to randomization through to the end of the treatment period. After Week 12, additional treatment can be started or the dose of concomitant medications can be increased, if no improvement in clinical response is observed; in these cases EASI, IGA, and photography evaluations will be stopped. The study duration for each participant is expected to be approximately 30 weeks. Ustekinumab (also known as STELARA) is an antibody medication that inhibits the inflammatory proteins IL-12 and IL-23 and is approved as a treatment for moderate to severe plaque-type psoriasis; this study will examine whether ustekinumab can provide benefit in atopic dermatitis and assess for any risks or side effects. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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 |
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 | |
Terminated |
NCT02582788 -
Bathing Additives in Pediatric Atopic Dermatitis
|
N/A |