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A Phase II Study in Adult Patients With Moderate to Severe Atopic Dermatitis

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: NCT04162899
Recruitment Status : Recruiting
First Posted : November 14, 2019
Last Update Posted : September 15, 2020
Sponsor:
Information provided by (Responsible Party):
Reistone Biopharma Company Limited

Brief Summary:

This proposed study is a randomized, double-blind, placebo-controlled, 3-arm parallel, multicenter phase II study, designed to explore the efficacy and safety of SHR0302 treatment for patients with moderate to severe atopic dermatitis.

The study will be conducted over a 12-week treatment period. Two active doses of SHR0302 will be compared to placebo and improvement in atopic dermatitis will be assessed using the Investigator's Global Score (IGA)


Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Drug: SHR0302 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind and Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of SHR0302 in Adult Patients With Moderate to Severe Atopic Dermatitis
Actual Study Start Date : November 15, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Active Comparator: Active Comparator: SHR0302 dose A
Participants randomized in this arm will receive dose A of SHR0302 until end of study at week 12.
Drug: Drug: SHR0302
The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor).

Active Comparator: Active Comparator: SHR0302 dose B
Participants randomized in this arm will receive dose B of SHR0302 until end of study at week 12.
Drug: Drug: SHR0302
The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor).

Active Comparator: Placebo Comparator: Placebo
Participants randomized in this arm will receive Placebo of SHR0302 until end of study at week 12.
Drug: Drug: SHR0302
The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor).




Primary Outcome Measures :
  1. The percentage of subjects achieving Investigator's Global Score (IGA) response which improvement ≥ 2 from baseline. [ Time Frame: At week 12 ]
    The IGA is a validated assessment instrument used in clinical studies to rate the severity of AD globally.


Secondary Outcome Measures :
  1. Percentage of czema Area and Severity Index (EASI) change. [ Time Frame: Up to week 12 ]
    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis (AD).

  2. Percentage of Subjects Achieving Investigator's Global Score (IGA) Response [ Time Frame: Up to week 8 ]
    The IGA is a validated assessment instrument used in clinical studies to rate The IGA is a validated assessment instrument used in clinical studies to rate the severity of AD globally.

  3. Percent of pruritus numerical rating scale (NRS) change [ Time Frame: Up to week 12 ]
    The Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period.



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:

  • Subjects between 18-75 years of age (inclusive), male or female, at the time of informed consent
  • Moderate to severe atopic dermatitis
  • Capable of providing a signed and dated informed consent form indicating the subject has been informed of all pertinent aspect of the study

Exclusion Criteria:

  • Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study
  • Subject has a current diagnosis of other active skin disease (e.g., psoriasis or lupus erythematosus) or skin infection (bacterial, fungal, or viral) that may affect the evaluation of atopic dermatitis
  • Subject has a severe comorbidity that may require systemic steroids therapy or other interventions or requires active frequent monitoring (e.g., unstable chronic asthma)

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): NCT04162899


Contacts
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Contact: Bo Wei, Bachelor +86-21-68813320 bo.wei@reistonebio.com
Contact: Elaine Cheng, Master +86-21-68813358 Elaine.cheng@reistonbio.com

Locations
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China, Beijing
Peking University People's Hospital Recruiting
Xicheng, Beijing, China
Contact: Jianzhong Zhang, MD    8618001315877    rmzjz@126.com   
Sponsors and Collaborators
Reistone Biopharma Company Limited
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Responsible Party: Reistone Biopharma Company Limited
ClinicalTrials.gov Identifier: NCT04162899    
Other Study ID Numbers: RSJ10303
First Posted: November 14, 2019    Key Record Dates
Last Update Posted: September 15, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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