Evaluate Efficacy and Safety of Oral SHR0302 in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis

NCT ID: NCT04875169

Last Updated: 2023-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 336 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-30
• Study Completion Date: 2023-05-23

Brief Summary

This is a randomized, double-blind, placebo-controlled, multicenter Phase 3 study that will enroll approximately 330 subjects aged 12 to 75 years old with moderate to severe atopic dermatitis.

Detailed Description

This study consists of a screening period followed by a placebo-controlled treatment period and then an extension treatment period and completed after a follow-up period after the completion of active treatment.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Core Treatment Active Experimental: SHR0302 Dose#1

Drug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks

Group Type: EXPERIMENTAL

Core Treatment Active Experimental: SHR0302 Dose#1

Intervention Type: DRUG

Drug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks

Core Treatment Active Experimental: SHR0302 Dose#2

Drug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks

Group Type: EXPERIMENTAL

Core Treatment Active Experimental: SHR0302 Dose#2

Intervention Type: DRUG

Drug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks

Core Treatment Placebo Comparator: Placebo

Drug: Placebo Oral tablets taken once daily (QD) for 16 weeks

Group Type: PLACEBO_COMPARATOR

Core Treatment Placebo Comparator: Placebo

Intervention Type: DRUG

Drug: Placebo Oral tablets taken once daily (QD) for 16 weeks

Extension Treatment Active Experimental: SHR0302 Dose#1

Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks

Group Type: EXPERIMENTAL

Extension Treatment Active Experimental: SHR0302 Dose#1

Intervention Type: DRUG

Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks

Extension Treatment Active Experimental: SHR0302 Dose#2

Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks

Group Type: EXPERIMENTAL

Extension Treatment Active Experimental: SHR0302 Dose#2

Intervention Type: DRUG

Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks

Interventions

Extension Treatment Active Experimental: SHR0302 Dose#1

Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks

Intervention Type: DRUG

Extension Treatment Active Experimental: SHR0302 Dose#2

Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks

Intervention Type: DRUG

Core Treatment Active Experimental: SHR0302 Dose#1

Drug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks

Intervention Type: DRUG

Core Treatment Active Experimental: SHR0302 Dose#2

Drug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks

Intervention Type: DRUG

Core Treatment Placebo Comparator: Placebo

Drug: Placebo Oral tablets taken once daily (QD) for 16 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female subjects must be at least at ≥12 and ≤75 years of age and body weight ≥40 kg

2. Subject has a diagnosis of atopic dermatitis for at least 1 year.

3. Meets all of the following disease activity criteria: BSA ≥10% of AD involvement. EASI ≥16. IGA ≥3. WI-NRS ≥4

4. Subject has a recent history (within 6 months before the screening visit) of inadequate response or inability to tolerate topical AD treatments (TCS or TCI) or who have required systemic treatments for control of their disease.

5. Are willing to discontinue certain treatments for eczema (such as systemic and topical treatments during a washout period).

Exclusion Criteria

1. Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, malignancies, current or history of certain infections, lymphoproliferative disorders and other medical conditions at the discretion of the investigator.

2. Have received certain treatments that are contraindicated.

3. Subject currently has been diagnosed and has active forms of other inflammatory skin disease (e.g., psoriasis, or lupus erythematosus) that would interfere with the evaluation of atopic dermatitis or response to treatment.

4. Other active non-AD inflammatory skin diseases or conditions affecting skin

5. Subject with active/severe concomitant disease (s)/symptom(s) that requires administering of systemic corticosteroids or otherwise interferes with study participation or requires active frequent monitoring (e.g., unstable chronic asthma).

6. Acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation.

7. Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, malignancies, current or history of certain infections, lymphoproliferative disorders and other medical conditions at the discretion of the investigator.

8. Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study

9. Subject has any malignancies or has a history of malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ.

10. Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception.

11. Subject has a previously received systemic JAK inhibitors

12. Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Reistone Biopharma Company Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dermatology Research Institute Inc.

Calgary, Alberta, Canada

Dr Chih-ho Hong Medical Inc.

Surrey, British Columbia, Canada

Enverus Medical Research

Surrey, British Columbia, Canada

Wiseman Dermatology Research

Winnipeg, Manitoba, Canada

CCA Medical Research

Ajax, Ontario, Canada

SKiN Health

Cobourg, Ontario, Canada

DermEffects

London, Ontario, Canada

North York Research Inc.

North York, Ontario, Canada

The Centre for Dermatology

Richmond Hill, Ontario, Canada

York Dermatology

Richmond Hill, Ontario, Canada

Toronto Research Centre

Toronto, Ontario, Canada

Research Toronto

Toronto, Ontario, Canada

AvantDerm

Toronto, Ontario, Canada

XLR8 Clinical Research

Windsor, Ontario, Canada

Clinique D

Laval, Quebec, Canada

First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

The second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Peking University People's Hospital

Beijing, Beiing, China

First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Zhongshan Hospital, Fudan University(Xiamen Branch)

Xiamen, Fujian, China

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, China

Guangdong Province Traditional Chinese Medical Hospital

Guangzhou, Guangdong, China

The First affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Wuhan No.1 Hospital

Wuhan, Hubei, China

Xiangya Hospital of Central South University

Changsha, Hunan, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Hospital for Skin Diseases, Chinese Academy of medical sciences

Nanjing, Jiangsu, China

Jiangsu province people's hospital

Nanjing, Jiangsu, China

Wuxi No.2 People's Hospital

Wuxi, Jiangsu, China

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, China

Jiangxi Provincial Hospital of Dermatology

Nanchang, Jiangxi, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The first hospital of jilin university

Changchun, Jilin, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

The Children's Hospital Affiliated to Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

The first people's hospital of hangzhou

Hangzhou, Zhejiang, China

The fourth hospital affiliated to zhejiang university school of medicine

Yiwu, Zhejiang, China

Beijing Children's Hospital, Capital Medical University

Beijing, , China

Peking University third hospital

Beijing, , China

Peking union medical college hospital

Beijing, , China

Children's Hospital Capital Institute of Pediatrics

Beijing, , China

The Third Xiangya Hospital of Central South University

Changsha, , China

Chongqing Traditional Chinese medicine Hospital

Chongqing, , China

First affiliated hospital of chongqing medical university

Chongqing, , China

The Southwest Hospital of AMU

Chongqing, , China

Zhejiang province People's Hospital

Hangzhou, , China

Dermatology hospital of Shanghai

Shanghai, , China

Huashan Hospital Affiliated to Fudan University

Shanghai, , China

The first hospital of China medical university

Shenyang, , China

Countries

Canada; China

References

Zhao Y, Gooderham M, Yang B, Wu J, Wu L, Loo WJ, Toth D, Sauder M, Li J, Chen A, Tao X, Lu J, Song Z, Han J, Li H, Li Y, Xu L, Zhang J. Ivarmacitinib for Moderate to Severe Atopic Dermatitis in Adults and Adolescents: A Phase 3 Randomized Clinical Trial. JAMA Dermatol. 2025 Jul 1;161(7):688-697. doi: 10.1001/jamadermatol.2025.0982.

Reference Type: DERIVED

PMID: 40305055 (View on PubMed)

Other Identifiers

RSJ10333

Identifier Type: -

Identifier Source: org_study_id