A Phase II Study in Patients With Alopecia Areata

Sponsor

Reistone Biopharma Company Limited (Industry)

Overall Status

Completed

CT.gov ID

NCT04346316

Collaborator

(none)

Enrollment

Locations

Arms

13.5

Actual Duration (Months)

2.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a global Phase 2 study to evaluate the safety and effectiveness of an investigational study drug (called SHR0302) in adults with moderate to severe alopecia areata.

Condition or Disease	Intervention/Treatment	Phase
Alopecia Areata	Drug: SHR0302	Phase 2

Detailed Description

The study is placebo-controlled, meaning that some patients entering the study will not receive active study drug but will receive tablets with no active ingredients (a placebo). This is a dose-ranging study, investigating 3 different dosing regimens. It will be double-blinded, meaning that the sponsor, the study doctors, the staff, and the patients will not know whether a patient is on active study drug (or the dose) or placebo.

Study Design

Study Type:

Interventional

Actual Enrollment :

94 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double Blind and Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of SHR0302 Tablets in Adult Patients With Alopecia Areata

Actual Study Start Date :

May 13, 2020

Actual Primary Completion Date :

Jun 10, 2021

Actual Study Completion Date :

Jun 29, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: SHR0302 Dose#1	Drug: SHR0302 Oral tablets taken once daily (QD)
Active Comparator: SHR0302 Dose#2	Drug: SHR0302 Oral tablets taken once daily (QD)
Active Comparator: SHR0302 Dose#3	Drug: SHR0302 Oral tablets taken once daily (QD)
Placebo Comparator: Placebo	Drug: SHR0302 Oral tablets taken once daily (QD)

Outcome Measures

Primary Outcome Measures

Percentage change from baseline in Severity of Alopecia Tool (SALT) score [week 24]
Severity of alopecia tool is a quantitative assessment of AA severity based on scalp hair loss

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female subjects between 18-65 years of age (both inclusive), at the time of informed consent;
Must have moderate to severe alopecia areata.

Exclusion Criteria:

Other types of alopecia or other diseases that can cause hair loss
Other scalp diseases that could interfere with assessment of hair loss/regrowth
Any previous use of any Janus kinase (JAK) inhibitor

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Quest Dermatology Research	Northridge	California	United States	91324
2	Moore Clinical Research	Brandon	Florida	United States	33511
3	Dawes Fretzin Clinical Research	Indianapolis	Indiana	United States	46250
4	Skin Search of Rochester, Inc	Rochester	New York	United States	14623
5	Dermatologists of Southwest Ohio	Mason	Ohio	United States	45040
6	The Skin Wellness Center	Knoxville	Tennessee	United States	37922
7	Progressive Clinical Research	San Antonio	Texas	United States	78213
8	St George Dermatology and Skin Cancer Centre	Kogarah	New South Wales	Australia	2217
9	Novatrials	Kogarah	New South Wales	Australia	2289
10	Veracity Clinical Research	Woolloongabba	Queensland	Australia	4102
11	Skin Health Institute	Carlton	Victoria	Australia	3053
12	Sinclair Dermatology	East Melbourne	Victoria	Australia	3002
13	Sinclair Dermatology	Melbourne	Victoria	Australia	3002
14	China-Japan Friendship Hospital	Beijing	Beijing	China	100029
15	Peking University First Hospital	Beijing	Beijing	China	100034
16	Peking University People's Hospital	Beijing	Beijing	China	100044
17	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing	China	100050
18	Beijing Tongren Hospital, Capital Medical University	Beijing	Beijing	China	100730
19	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing	China
20	Beijing Tongren Hospital, Capital Medical University	Beijing	Beijing	China
21	Peking University People's Hospital	Beijing	Beijing	China
22	Chongqing Traditional Chinese medicine Hospital	Chongqing	Chongqing	China	400011
23	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing	China	400016
24	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian	China	350005
25	Guangdong Provincial People's Hospital	Guangzhou	Guangdong	China	510030
26	The Dermatology Hospital of Nanfang Medical University	Guangzhou	Guangdong	China
27	The Dermatology Hospital of Nanfang Medical University	Guangzhou	Guangzhou	China
28	Henan Provincial People's Hospital	Zhengzhou	Henan	China	450003
29	Jiangsu Province People's Hospital	Nanjin	Jiangsu	China	210029
30	The First Hospital of China Medical University	Shenyang	Liaoning	China	110001
31	Shanghai Skin Disease Hospital	Shanghai	Shanghai	China	200071
32	Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital	Tianjin	Tianjin	China	300120
33	The First Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang	China	310003
34	SIR RUN RUN Shaw Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang	China	310020

Sponsors and Collaborators

Reistone Biopharma Company Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Reistone Biopharma Company Limited

ClinicalTrials.gov Identifier:

NCT04346316

Other Study ID Numbers:

RSJ10521

First Posted:

Apr 15, 2020

Last Update Posted:

Jul 16, 2021

Last Verified:

Nov 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Alopecia

Alopecia Areata

Study Results

No Results Posted as of Jul 16, 2021