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

Reistone Biopharma

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: Drug: SHR0302

Study type: Interventional

Funder types: Industry

Identifiers

NCT04162899

RSJ10303

Details and patient eligibility

About

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)

Enrollment: 105 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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105 participants in 3 patient groups

Active Comparator: SHR0302 dose A

Active Comparator group

Description:

Participants randomized in this arm will receive dose A of SHR0302 until end of study at week 12.

Treatment:

Drug: Drug: SHR0302

Active Comparator: SHR0302 dose B

Active Comparator group

Description:

Participants randomized in this arm will receive dose B of SHR0302 until end of study at week 12.

Treatment:

Drug: Drug: SHR0302

Placebo Comparator: Placebo

Active Comparator group

Description:

Participants randomized in this arm will receive Placebo of SHR0302 until end of study at week 12.

Treatment:

Drug: Drug: SHR0302