Atopic DermatitisPhase 2NCT04162899
A Phase II Study in Adult Patients With Moderate to Severe Atopic Dermatitis
A Phase 2 study testing Drug: SHR0302 in people with Atopic Dermatitis, run by Reistone Biopharma Company Limited at 23 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Drug: SHR0302
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 23 sitesChina
- Study dates
- 6 Nov 2019to 31 Aug 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
23 sites in 1 country.
23 sites in 1 country
China23 sites
Xuanwu Hospital Capital Medical University
Beijing, 100053
Peking University Third Hospital
Beijing, 100083
Peking union medical college hospital
Beijing, 100730
Beijing Tsinghua Changgeng Hospital
Beijing, 102218
The Second Xiangya Hospital of Central South University
Changsha, 410008
Xiangya Hospital of Central South University
Changsha, 410008
The Third Xiangya Hospital of Central South University
Changsha, 410013
Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)
Chongqing, 400037
The First Affiliated Hospital of Fujian Medical University
Fuzhou, 350005
Guangdong Provincial People's Hospital
Guangzhou, 510000
Sun. Yat- Sen Memorial Hospital, Sun. Yat- Sen University
Guangzhou, 51000
The first affiliated hospital Zhejiang university
Hangzhou, 310003
Affiliated Hangzhou first people's hospital, Zhejiang university school of medicine
Hangzhou, 310006
Zhejiang province People's Hospital
Hangzhou, 310014
Jinan Central Hospital
Jinan, 250013
Shanghai Skin Disease Hospital
Shanghai, 200050
The first hospital of China medical university
Shenyang, 110001
The First Affiliated Hospital of Soochow University
Suzhou, 215006
The First Hospital of Shanxi Medical University
Taiyuan, 030001
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin, Tianjin Municipality, 300120
Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
Wuhan, 430022
Peking University People's Hospital
Xicheng, Beijing Municipality
Henan provincial people's hospital
Zhengzhou, 450003
About this study
Official title: A Randomized, Double-Blind and Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of SHR0302 in Adult Patients With Moderate to Severe Atopic Dermatitis
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)
- Conditions
- Atopic Dermatitis
- Being tested
- Drug: SHR0302
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: SHR0302Drug
The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor).
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: SHR0302 dose A | Active comparator | Participants randomized in this arm will receive dose A of SHR0302 until end of study at week 12. Receives: Drug: Drug: SHR0302 |
| Active Comparator: SHR0302 dose B | Active comparator | Participants randomized in this arm will receive dose B of SHR0302 until end of study at week 12. Receives: Drug: Drug: SHR0302 |
| Placebo Comparator: Placebo | Active comparator | Participants randomized in this arm will receive Placebo of SHR0302 until end of study at week 12. Receives: Drug: Drug: SHR0302 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Response Which Improvement ≥ 2 From Baseline.
The IGA is a validated assessment instrument used in clinical studies to rate the severity of AD globally. IGA response was defined as IGA score of 0/1 (complete or almost complete clearance of skin lesions) with an improvement in IGA score by ≥ 2 from baseline.
Measured: At week 12
Secondary outcomes (3)
Percentage of Czema Area and Severity Index (EASI) Change.
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis (AD).
Measured: Up to week 12
Percentage of Subjects Achieving Investigator's Global Score (IGA) Response
The IGA is a validated assessment instrument used in clinical studies to rate The IGA is a validated assessment instrument used in clinical studies to rate the severity of AD globally.
Measured: Up to week 8
Percent of Pruritus Numerical Rating Scale (NRS) Change
The Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period.
Measured: Up to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start6 Nov 2019
- Primary completion21 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reistone Biopharma Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162899
- Sponsor's protocol ID
- RSJ10303
- Status last verified
- Jun 2022
- First submitted
- 15 Oct 2019
- Last updated
- 9 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhao Y, Zhang L, Ding Y, Tao X, Ji C, Dong X, Lu J, Wu L, Wang R, Lu Q, Goh AH, Liu R, Zhang Z, Zhang J. Efficacy and Safety of SHR0302, a Highly Selective Janus Kinase 1 Inhibitor, in Patients with Moderate to Severe Atopic Dermatitis: A Phase II Randomized Clinical Trial. Am J Clin Dermatol. 2021 Nov;22(6):877-889. doi: 10.1007/s40257-021-00627-2. Epub 2021 Aug 9.
PubMed 34374027
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind and Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of SHR0302 in Adult Patients With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT04162899
- Acronym / sponsor ID
- RSJ10303
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Reistone Biopharma Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2019 (actual)
- Primary completion
- 21 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 14 Nov 2019 (actual)
- Results
- Posted 9 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: SHR0302 dose A | Active comparator | Drug: Drug: SHR0302Participants randomized in this arm will receive dose A of SHR0302 until end of study at week 12. |
| Active Comparator: SHR0302 dose B | Active comparator | Drug: Drug: SHR0302Participants randomized in this arm will receive dose B of SHR0302 until end of study at week 12. |
| Placebo Comparator: Placebo | Active comparator | Drug: Drug: SHR0302Participants randomized in this arm will receive Placebo of SHR0302 until end of study at week 12. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
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 |
|---|---|---|
| Drug: SHR0302The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor). | Drug | Active Comparator: SHR0302 dose A, Active Comparator: SHR0302 dose B, Placebo Comparator: Placebo |
Primary outcome
The Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Response Which Improvement ≥ 2 From Baseline.
Time frame: At week 12
The IGA is a validated assessment instrument used in clinical studies to rate the severity of AD globally. IGA response was defined as IGA score of 0/1 (complete or almost complete clearance of skin lesions) with an improvement in IGA score by ≥ 2 from baseline.
3 secondary outcomes
Percentage of Czema Area and Severity Index (EASI) Change.
Time frame: Up to week 12
Percentage of Subjects Achieving Investigator's Global Score (IGA) Response
Time frame: Up to week 8
Percent of Pruritus Numerical Rating Scale (NRS) Change
Time frame: Up to week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34374027Zhao Y, Zhang L, Ding Y, Tao X, Ji C, Dong X, Lu J, Wu L, Wang R, Lu Q, Goh AH, Liu R, Zhang Z, Zhang J. Efficacy and Safety of SHR0302, a Highly Selective Janus Kinase 1 Inhibitor, in Patients with Moderate to Severe Atopic Dermatitis: A Phase II Randomized Clinical Trial. Am J Clin Dermatol. 2021 Nov;22(6):877-889. doi: 10.1007/s40257-021-00627-2. Epub 2021 Aug 9.
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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.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Drug: SHR0302 in people with Atopic Dermatitis, run by Reistone Biopharma Company Limited at 23 sites in China.
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 3 inclusion and 3 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 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in China. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Response Which Improvement ≥ 2 From Baseline. (time frame: At week 12). 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 NCT04162899, 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 9 May 2023.