Atopic DermatitisPhase 3NCT04875169

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

A Phase 3 study testing Core Treatment Active Experimental: SHR0302 Dose#1, Core Treatment Active Experimental: SHR0302 Dose#2 and Extension Treatment Active Experimental: SHR0302 Dose#1 in people with Atopic Dermatitis, run by Reistone Biopharma Company Limited at 52 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 12 to 75 years
Conditions the study is for: Atopic Dermatitis
What is being tested?: Core Treatment Active Experimental: SHR0302 Dose#1, Core Treatment Active Experimental: SHR0302 Dose#2 and Extension Treatment Active Experimental: SHR0302 Dose#1
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 336 participants
Where: 52 sitesin 2 countries
Study dates: 30 Apr 2021to 23 May 2023
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 75 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Male or female subjects must be at least at ≥12 and ≤75 years of age and body weight ≥40 kg
Subject has a diagnosis of atopic dermatitis for at least 1 year.
Meets all of the following disease activity criteria: BSA ≥10% of AD involvement. EASI ≥16. IGA ≥3. WI-NRS ≥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.
Are willing to discontinue certain treatments for eczema (such as systemic and topical treatments during a washout period).

Who cannot join

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.
Have received certain treatments that are contraindicated.
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.
Other active non-AD inflammatory skin diseases or conditions affecting skin
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).
Acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation.

Show all 12Show fewer

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.
Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
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.
Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception.
Subject has a previously received systemic JAK inhibitors
Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study

Trial locations and contacts

52 sites in 2 countries.

Country

City, postcode or hospital

52 sites in 2 countries

China37 sites

Peking University People's Hospital
Beijing, Beiing, 100044
Beijing Children's Hospital, Capital Medical University
Beijing, 100045
Peking University third hospital
Beijing, 100191
Peking union medical college hospital
Beijing, 100730
Children's Hospital Capital Institute of Pediatrics
Beijing
The first hospital of jilin university
Changchun, Jilin
Xiangya Hospital of Central South University
Changsha, Hunan, 410008
The Second Xiangya Hospital of Central South University
Changsha, Hunan
The Third Xiangya Hospital of Central South University
Changsha, 410013
West China Hospital of Sichuan University
Chengdu, Sichuan
Chongqing Traditional Chinese medicine Hospital
Chongqing
First affiliated hospital of chongqing medical university
Chongqing
The Southwest Hospital of AMU
Chongqing
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong
Guangdong Province Traditional Chinese Medical Hospital
Guangzhou, Guangdong
The First affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
The Children's Hospital Affiliated to Zhejiang University School of Medicine
Hangzhou, Zhejiang
The first people's hospital of hangzhou
Hangzhou, Zhejiang
Zhejiang province People's Hospital
Hangzhou, 310014
First Affiliated Hospital of Anhui Medical University
Hefei, Anhui
The second Affiliated Hospital of Anhui Medical University
Hefei, Anhui
Jiangxi Provincial Hospital of Dermatology
Nanchang, Jiangxi
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
The second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Hospital for Skin Diseases, Chinese Academy of medical sciences
Nanjing, Jiangsu
Jiangsu province people's hospital
Nanjing, Jiangsu
Dermatology hospital of Shanghai
Shanghai
Huashan Hospital Affiliated to Fudan University
Shanghai
The first hospital of China medical university
Shenyang, 110001
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin, Tianjin Municipality, 300120
Wuhan No.1 Hospital
Wuhan, Hubei
Wuxi No.2 People's Hospital
Wuxi, Jiangsu
Zhongshan Hospital, Fudan University(Xiamen Branch)
Xiamen, Fujian
The fourth hospital affiliated to zhejiang university school of medicine
Yiwu, Zhejiang
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu

Other trials in China

Canada15 sites

CCA Medical Research
Ajax, Ontario, L1S 7K8
Dermatology Research Institute Inc.
Calgary, Alberta, T2J 7E1
SKiN Health
Cobourg, Ontario, K9A 0Z4
Clinique D
Laval, Quebec, H7N 6L2
DermEffects
London, Ontario, N6H 5L5
North York Research Inc.
North York, Ontario, M2M 4J5
The Centre for Dermatology
Richmond Hill, Ontario, L4B 1A5
York Dermatology
Richmond Hill, Ontario, L4C 9M7
Dr Chih-ho Hong Medical Inc.
Surrey, British Columbia, V3R 6A7
Enverus Medical Research
Surrey, British Columbia, V3V 0C6
Toronto Research Centre
Toronto, Ontario, M3H 5Y8
Research Toronto
Toronto, Ontario, M4W 2N4
AvantDerm
Toronto, Ontario, M5A 3R6
XLR8 Clinical Research
Windsor, Ontario, N8W 1E6
Wiseman Dermatology Research
Winnipeg, Manitoba, R3M 3Z4

Other trials in Canada

About this study

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

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.

Read the 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
Being tested: Core Treatment Active Experimental: SHR0302 Dose#1, Core Treatment Active Experimental: SHR0302 Dose#2, Core Treatment Placebo Comparator: Placebo, Extension Treatment Active Experimental: SHR0302 Dose#1, Extension Treatment Active Experimental: SHR0302 Dose#2
Medical subject headings: Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Core Treatment Active Experimental: SHR0302 Dose#1Drug
Drug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks
Core Treatment Active Experimental: SHR0302 Dose#2Drug
Drug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks
Core Treatment Placebo Comparator: PlaceboDrug
Drug: Placebo Oral tablets taken once daily (QD) for 16 weeks
Extension Treatment Active Experimental: SHR0302 Dose#1Drug
Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks
Extension Treatment Active Experimental: SHR0302 Dose#2Drug
Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks

Study groups in NCT04875169
Study group	Role	What they receive
Core Treatment Active Experimental: SHR0302 Dose#1	Experimental	Drug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks Receives: Drug: Core Treatment Active Experimental: SHR0302 Dose#1
Core Treatment Active Experimental: SHR0302 Dose#2	Experimental	Drug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks Receives: Drug: Core Treatment Active Experimental: SHR0302 Dose#2
Core Treatment Placebo Comparator: Placebo	Placebo comparator	Drug: Placebo Oral tablets taken once daily (QD) for 16 weeks Receives: Drug: Core Treatment Placebo Comparator: Placebo
Extension Treatment Active Experimental: SHR0302 Dose#1	Experimental	Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks Receives: Drug: Extension Treatment Active Experimental: SHR0302 Dose#1
Extension Treatment Active Experimental: SHR0302 Dose#2	Experimental	Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks Receives: Drug: Extension Treatment Active Experimental: SHR0302 Dose#2

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 16 Weeks
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.
Measured: 16 Weeks

Secondary outcomes (5)

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
Measured: Week 16
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.
Measured: Week 1, 4, 8 and 12
Time to WI-NRS response
Time from baseline to achieve at least 4 points improvement of WI-NRS during placebo-controlled treatment phase.
Measured: Baseline to Week 16
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.
Measured: Week 1, 4, 8 and 12
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.
Measured: Week 1, 4, 8 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Apr 202123 May 2023

First posted6 May 2021
Study start30 Apr 2021
Primary completion12 Aug 2022
Study completion23 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Atopic DermatitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 336 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04875169
Sponsor's protocol ID: RSJ10333
Status last verified: Mar 2023
First submitted: 1 May 2021
Last updated: 1 Jun 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 40305055

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Atopic Dermatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04875169
Acronym / sponsor ID: RSJ10333
Conditions: Atopic Dermatitis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 336 participants (actual)
Lead sponsor: Reistone Biopharma Company LimitedIndustry (pharma, biotech, devices)
Study start: 30 Apr 2021 (actual)
Primary completion: 12 Aug 2022 (actual)
Study completion: 23 May 2023 (actual)
First posted: 6 May 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Core Treatment Active Experimental: SHR0302 Dose#1	Experimental	Drug: Core Treatment Active Experimental: SHR0302 Dose#1Drug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks
Core Treatment Active Experimental: SHR0302 Dose#2	Experimental	Drug: Core Treatment Active Experimental: SHR0302 Dose#2Drug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks
Core Treatment Placebo Comparator: Placebo	Placebo comparator	Drug: Core Treatment Placebo Comparator: PlaceboDrug: Placebo Oral tablets taken once daily (QD) for 16 weeks
Extension Treatment Active Experimental: SHR0302 Dose#1	Experimental	Drug: Extension Treatment Active Experimental: SHR0302 Dose#1Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks
Extension Treatment Active Experimental: SHR0302 Dose#2	Experimental	Drug: Extension Treatment Active Experimental: SHR0302 Dose#2Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks

Who may qualify

Ages: 12 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

Male or female subjects must be at least at ≥12 and ≤75 years of age and body weight ≥40 kg
Subject has a diagnosis of atopic dermatitis for at least 1 year.
Meets all of the following disease activity criteria: BSA ≥10% of AD involvement. EASI ≥16. IGA ≥3. WI-NRS ≥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.
Are willing to discontinue certain treatments for eczema (such as systemic and topical treatments during a washout period).

Key exclusion criteria (12 listed)

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.
Have received certain treatments that are contraindicated.
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.
Other active non-AD inflammatory skin diseases or conditions affecting skin
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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Core Treatment Active Experimental: SHR0302 Dose#1Drug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks	Drug	Core Treatment Active Experimental: SHR0302 Dose#1
Core Treatment Active Experimental: SHR0302 Dose#2Drug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks	Drug	Core Treatment Active Experimental: SHR0302 Dose#2
Core Treatment Placebo Comparator: PlaceboDrug: Placebo Oral tablets taken once daily (QD) for 16 weeks	Drug	Core Treatment Placebo Comparator: Placebo
Extension Treatment Active Experimental: SHR0302 Dose#1Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks	Drug	Extension Treatment Active Experimental: SHR0302 Dose#1
Extension Treatment Active Experimental: SHR0302 Dose#2Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks	Drug	Extension Treatment Active Experimental: SHR0302 Dose#2

Primary outcome

Investigator's Global Assessment (IGA) score of 0/1 at Week 16
Time frame: 16 Weeks
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.
Eczema Area and Severity Index (EASI 75) at Week 16
Time frame: 16 Weeks
Proportion of subjects achieving at least a 75% improvement in Eczema Area and Severity Index (EASI 75) from baseline at Week 16.

5 secondary outcomes

Worst-Itch Numeric Rating Scale (WI-NRS-4)-4 at Week 16
Time frame: Week 16
Worst-Itch Numeric Rating Scale (WI-NRS) at Week 1, 4, 8 and 12
Time frame: Week 1, 4, 8 and 12
Time to WI-NRS response
Time frame: Baseline to Week 16
EASI 75 at Week 1, 4, 8 and 12
Time frame: Week 1, 4, 8 and 12
IGA 0/1 at Week 1, 4, 8 and 12
Time frame: Week 1, 4, 8 and 12

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
Derived from this study: PubMed 40305055Zhao 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.

Related trials for Atopic Dermatitis

Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
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Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
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RecruitingPhase 3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

52 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in China, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Investigator's Global Assessment (IGA) score of 0/1 at Week 16 (time frame: 16 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04875169, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.