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

Atopic Dermatitis Clinical Trial

Official title:

A Randomized, Double Blind and Placebo Controlled Phase 3 Study to Evaluate Efficacy and Safety of Oral SHR0302 in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04875169
• Other study ID #: RSJ10333
• Status: Completed
• Phase: Phase 3
• Start date: April 30, 2021
• Est. completion date: May 23, 2023

Study information

• Verified date: March 2023
• Source: Reistone Biopharma Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 336
• Est. completion date: May 23, 2023
• Est. primary completion date: August 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Core Treatment Active Experimental: SHR0302 Dose#1
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
• Core Treatment Placebo Comparator: Placebo
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
• Extension Treatment Active Experimental: SHR0302 Dose#2
Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks

Locations

Country	Name	City	State
Canada	CCA Medical Research	Ajax	Ontario
Canada	Dermatology Research Institute Inc.	Calgary	Alberta
Canada	SKiN Health	Cobourg	Ontario
Canada	Clinique D	Laval	Quebec
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	Dr Chih-ho Hong Medical Inc.	Surrey	British Columbia
Canada	Enverus Medical Research	Surrey	British Columbia
Canada	AvantDerm	Toronto	Ontario
Canada	Research Toronto	Toronto	Ontario
Canada	Toronto Research Centre	Toronto	Ontario
Canada	XLR8 Clinical Research	Windsor	Ontario
Canada	Wiseman Dermatology Research	Winnipeg	Manitoba
China	Beijing Children's Hospital, Capital Medical University	Beijing
China	Children's Hospital Capital Institute of Pediatrics	Beijing
China	Peking union medical college hospital	Beijing
China	Peking University People's Hospital	Beijing	Beiing
China	Peking University third hospital	Beijing
China	The first hospital of jilin university	Changchun	Jilin
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	The Third Xiangya Hospital of Central South University	Changsha
China	Xiangya Hospital of Central South University	Changsha	Hunan
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	Chongqing Traditional Chinese medicine Hospital	Chongqing
China	First affiliated hospital of chongqing medical university	Chongqing
China	The Southwest Hospital of AMU	Chongqing
China	First Affiliated Hospital of Fujian Medical University	Fuzhou	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	The Children's Hospital Affiliated to Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The First Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The first people's hospital of hangzhou	Hangzhou	Zhejiang
China	Zhejiang province People's Hospital	Hangzhou
China	First Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	The second Affiliated Hospital of Anhui Medical University	Hefei	Anhui
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	Hospital for Skin Diseases, Chinese Academy of medical sciences	Nanjing	Jiangsu
China	Jiangsu province people's hospital	Nanjing	Jiangsu
China	Dermatology hospital of Shanghai	Shanghai
China	Huashan Hospital Affiliated to Fudan University	Shanghai
China	The first hospital of China medical university	Shenyang
China	Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital	Tianjin	Tianjin
China	Wuhan No.1 Hospital	Wuhan	Hubei
China	Wuxi No.2 People's Hospital	Wuxi	Jiangsu
China	Zhongshan Hospital, Fudan University(Xiamen Branch)	Xiamen	Fujian
China	The fourth hospital affiliated to zhejiang university school of medicine	Yiwu	Zhejiang
China	Affiliated Hospital of Jiangsu University	Zhenjiang	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Reistone Biopharma Company Limited

Countries where clinical trial is conducted

Canada,  China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	NRS-4 at Week 24, 32, 40, 52 and 56	Proportion of subjects achieving an improvement of WI-NRS =4 from baseline at all scheduled visits during extension treatment phase.	All scheduled visits from Week 24 - 56
Other	EASI 75 at Week 24, 32, 40, 52 and 56	Proportion of subjects achieving EASI 75 at all scheduled visits during extension treatment phase.	All scheduled visits from Week 16 24 - 56
Other	IGA 0/1 at Week 24, 32, 40, 52 and 56	Proportion of subjects achieving IGA0/1 and a reduction from baseline of =2 points at all scheduled visits during extension treatment phase.	All scheduled visits from Week 24 - 56
Other	EASI 50 and EASI 90 at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 56	Proportion of subjects with =50% EASI improvement from baseline (EASI 50) at all scheduled visits.	Day 1 to Week 56
Other	Change of EASI from baseline at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 56	Change from baseline in the eczema area and severity index (EASI) total score at all scheduled visits. The EASI score ranges from 0.0 to 72.0, can be varied in increments of 0.1, Higher scores indicate greater severity.	Day 1 to Week 56
Other	SCORAD 50, SCORAD 75 and SCORAD 90 at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 56	SCORing Atopic Dermatitis (SCORAD). Score of 0-103. Higher scores mean more severe. Proportion of subjects achieving a =50%, 75% and 90% improvement in SCORAD (SCORAD 50, SCORAD 75 and SCORAD 90) from baseline at all scheduled visits.	Day 1 to Week 56
Other	Change of SCORAD from baseline at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 56	Change from baseline in SCORAD at all scheduled visits	Day 1 to Week 56
Other	Change of BSA from baseline at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 56	Change from baseline in body surface area (BSA) affected at all scheduled visits	Day 1 to Week 56
Other	Change of IgE from baseline at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 56	Change from baseline in the level of serum IgE in peripheral blood at all scheduled visits.	Day 1 to Week 56
Other	Change of eosinophils from baseline at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 56	Change from baseline in the level of serum eosinophils in peripheral blood at all scheduled visits.	Day 1 to Week 56
Other	Change of dermatology life quality index (DLQI) or Children's DLQI (CDLQI) PROs from baseline at Week 4, 8, 12, 16, 24, 32, 40, 52 and 56	Change from baseline in dermatology life quality index (DLQI) or Children's DLQI (CDLQI) score at all scheduled visits. The DLQI CDLQI consists of questions concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week. This is not a scale. There are no minimum or maximum values. The quality index just captures a subjects perception of the impact of skin disease on different aspects of their health-related quality of life over the last week.	Day 1 to Week 56
Other	Change of Patient-Oriented Eczema Measure (POEM) from baseline at Week 4, 8, 12, 16, 24, 32, 40, 52 and 56	Change from baseline in Patient-Oriented Eczema Measure (POEM) at all scheduled visits. 7-item, patient-administered scale that assesses disease severity in children and adults. Subjects respond to questions about the frequency of 7 symptoms (itching, sleep disturbance, bleeding, weeping/oozing, cracking, flaking, and dryness/roughness) over the last week. Response categories include "No days," "1-2 days," "3-4 days," "5-6 days," and "Every day" with corresponding scores of 0, 1, 2, 3, and 4, respectively. Scores range from 0-28 with higher total scores indicating greater disease severity.	Day 1 to Week 56
Primary	Investigator's Global Assessment (IGA) score of 0/1 at Week 16	Proportion of subjects achieving Investigator's Global Assessment (IGA) score of clear (0) or almost clear (1) and a reduction from baseline of =2 points at Week 16.	16 Weeks
Primary	Eczema Area and Severity Index (EASI 75) at Week 16	Proportion of subjects achieving at least a 75% improvement in Eczema Area and Severity Index (EASI 75) from baseline at Week 16.	16 Weeks
Secondary	Worst-Itch Numeric Rating Scale (WI-NRS-4)-4 at Week 16	Proportion of subjects achieving an improvement of Worst-Itch Numeric Rating Scale (WI-NRS) =4 from baseline at Week 16	Week 16
Secondary	Worst-Itch Numeric Rating Scale (WI-NRS) at Week 1, 4, 8 and 12	Proportion of subjects achieving an improvement of WI-NRS =4 from baseline at all scheduled visits during placebo-controlled treatment phase other than Week 16.	Week 1, 4, 8 and 12
Secondary	Time to WI-NRS response	Time from baseline to achieve at least 4 points improvement of WI-NRS during placebo-controlled treatment phase.	Baseline to Week 16
Secondary	EASI 75 at Week 1, 4, 8 and 12	Proportion of subjects achieving EASI 75 at all scheduled visits during placebo-controlled treatment phase except Week 16.	Week 1, 4, 8 and 12
Secondary	IGA 0/1 at Week 1, 4, 8 and 12	Proportion of subjects achieving IGA0/1 and a reduction from baseline of =2 points at all scheduled visits during placebo-controlled treatment phase except Week 16.	Week 1, 4, 8 and 12