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NCT Number: NCT04162899

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

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)

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking University People's Hospital, Xicheng, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Drug: SHR0302

Drug

The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor).

Primary outcomes

  1. The Percentage of Subjects Achieving Investigator's Global Assessment (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. IGA response was defined as IGA score of 0/1 (complete or almost complete clearance of skin lesions) with an improvement in IGA score by ≥ 2 from baseline.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Reistone Biopharma Company Limited

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 14, 2019
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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