Atopic DermatitisPhase 2/3MARBLE-23NCT04717310
Evaluate the Efficacy and Safety of Topical SHR0302 Ointment in Patients With Mild-to-Moderate Atopic Dermatitis
A Phase 2/3 study testing SHR0302 Ointment in people with Atopic Dermatitis, run by Reistone Biopharma Company Limited at 31 sites in China.
Trial summary
This is a Randomized, Double-blind, Vehicle-Controlled, Seamless and Adaptive-designed Phase II/III Study to Evaluate the Efficacy and Safety of Topical SHR0302 Ointment in Adult Patients with Mild-to-Moderate Atopic Dermatitis. 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?
- SHR0302 Ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 645 participants
- Where
- 31 sitesChina
- Study dates
- 30 Dec 2020to 14 Jul 2024
- Phase
- Phase 2/3
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subject at least at ≥18 and ≤75years of age at time of informed consent.
- Have mild-to- moderate AD (Atopic Dermatitis), as determined by all of the following:
- Were diagnosed with AD (defined by the Hanifin and Rajka criteria)
- With AD history at least 6 months
- Capable of providing a signed and dated informed consent form indicating the subject has been informed of all pertinent aspect of the study
- All women of childbearing potential and all men must be willing to use at least one highly effective method of contraception from signing of informed consent, throughout the duration of the study, and for 28 days after last dose of study medication.
Who cannot join
- Subjects currently have active forms of other skin disease (e.g., psoriasis, or lupus erythematosus) that would interfere with evaluation of the effect of study medication on atopic dermatitis, or skin infections (bacteria, fungi, or viruses), or diseases that can cause skin itching (such as itching caused by diabetes), or subjects who are allergic to topical skin drugs
- Subjects with serious concomitant illness that could require administering of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring (e.g. unstable chronic asthma)
- Subjects who have a history of mental illness or disease such as anxiety and depression, and are not suitable to participate in this study
- Subjects with serious and uncontrolled disease that may affect the safety of the subject, compliance, affect the evaluation of the endpoint, or require the use of drugs that are not allowed in the protocol
- Subjects with Human immunodeficiency virus (HIV), or hepatitis B virus ,or hepatitis C virus ,or syphilis related laboratory test positive (subjects positive for hepatitis B surface antigen, HBV (hepatitis B virus) DNA must be greater than lower limit of detection
- Subjects with malignant tumors or a history of malignant tumors, except for fully treated or resected skin non-metastatic basal cell carcinoma or squamous cell carcinoma
Show all 9Show fewer
- Pregnant female subjects, breastfeeding female subjects, or male subjects able to father children and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in protocol for the duration of the study and for at least 28 days after last dose of investigational product.
- The investigators determined that there were conditions that affected the safety and efficacy of the investigational drug
- Subjects who, in the opinion of the investigator or Reistone, will be unsuitable for inclusion in the study.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
China31 sites
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Beijing Hospital
Beijing, Beijing Municipality
The Second Hospital of Jilin University
Changchun, Jilin
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, Chongqing Municipality
The First Hospital Affiliated to AMU (Southwest Hospital)
Chongqing, Chongqing Municipality
Xinqiao Hospital of AMU
Chongqing, Chongqing Municipality
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong
The First Affiliated Hospital Sun Yat-sen University
Guangzhou, Guangdong
Sun. Yat- Sen Memorial Hospital, Sun. Yat- Sen University
Guangzhou, 51000
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou
SIR RUN RUN Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310020
Hangzhou First People's Hospital
Hangzhou, Zhejiang
Hangzhou Third People's Hospital
Hangzhou, Zhejiang
Zhejiang province People's Hospital
Hangzhou, 310014
Anhui Provincial Hospital
Hefei, Anhui
Jiangxi Provincial Hospital of Dermatology
Nanchang, Jiangxi
Nanyang first people's Hospital
Nanyang, Henan
Hwa Mei Hospital
Ningbo, Zhejiang
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, 200071
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Huashan Hospital Fudan University
Shanghai
Shengjing Hospital of China Medical University
Shenyang, Liaoning
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin, Tianjin Municipality, 300120
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Wuhan NO.1 Hospital
Wuhan, Hubei
The Second People's Hospital of Wuxi
Wuxi, Jiangsu
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu
About this study
Official title: A Randomized, Double-blind, Vehicle-Controlled, Seamless and Adaptive-designed Phase II/III Study to Evaluate the Efficacy and Safety of Topical SHR0302 Ointment in Adult Patients With Mild-to-Moderate Atopic Dermatitis
This is a Randomized, Double-blind, Vehicle-Controlled, Seamless and Adaptive-designed Phase II/III Study to Evaluate the Efficacy and Safety of Topical SHR0302 Ointment in Adult Patients with Mild-to-Moderate Atopic Dermatitis.
It will consist of phase II and phase III parts, phase II will be a dose-ranging part and phase III will be a pivotal study part.
Read the detailed description
This study will evaluate the topical SHR0302 ointment, a JAK (Janus Kinase) inhibitor, in atopic dermatitis patients. The EASI (Eczema Area and Severity Index), IGA (immunoglobulin A), SCORAD (Scoring of Atopic Dermatitis),DLQI (Dermatology Life Quality Index)and NRS (Numeric Rating Score) will be applied to assesses to the efficacy, and other safety measurements will be also collected within the whole study duration.
- Conditions
- Atopic Dermatitis
- Being tested
- SHR0302 Ointment, Vehicle
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR0302 OintmentDrug
Also called SHR0302 Ointment 2%
SHR0302 Ointment Twice a day (BID)
SHR0302 OintmentDrug
Also called SHR0302 Ointment 1%
SHR0302 Ointment Twice a day (BID)
SHR0302 OintmentDrug
Also called SHR0302 Ointment 0.5%
SHR0302 Ointment Twice a day (BID)
VehicleDrug
Also called Placebo
Twice a day (BID)
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: SHR0302 Ointment Dose#1 | Active comparator | Drug: SHR0302 Ointment Twice a day (BID) Receives: Drug: SHR0302 Ointment |
| Active Comparator: SHR0302 Ointment Dose#2 | Active comparator | Drug: SHR0302 Ointment Twice a day (BID) Receives: Drug: SHR0302 Ointment |
| Active Comparator: SHR0302 Ointment Dose#3 | Active comparator | Drug: SHR0302 Ointment Twice a day (BID) Receives: Drug: SHR0302 Ointment |
| Placebo Comparator: Placebo | Placebo comparator | Drug: Vehicle Twice a day (BID) Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change from baseline in the eczema area and severity index (EASI) total score at Week 8
The percentage of subjects achieving the Investigator's Global Assessment（IGA）of clear (0) or almost clear (1) with a ≥2 points improvement from baseline at Week 8
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start30 Dec 2020
- Primary completion8 Sep 2023 (estimated)
- Study completion14 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 645 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reistone Biopharma Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yanhong Cheng, Study director, Reistone Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717310
- Sponsor's protocol ID
- RSJ10431
- Acronym
- MARBLE-23
- Status last verified
- Aug 2023
- First submitted
- 15 Jan 2021
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Vehicle-Controlled, Seamless and Adaptive-designed Phase II/III Study to Evaluate the Efficacy and Safety of Topical SHR0302 Ointment in Adult Patients With Mild-to-Moderate Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT04717310
- Acronym / sponsor ID
- MARBLE-23 / RSJ10431
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 645 participants (actual)
- Lead sponsor
- Reistone Biopharma Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2020 (actual)
- Primary completion
- 8 Sep 2023 (estimated)
- Study completion
- 14 Jul 2024 (estimated)
- First posted
- 22 Jan 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, Vehicle-Controlled, Seamless and Adaptive-designed Phase II/III Study to Evaluate the Efficacy and Safety of Topical SHR0302 Ointment in Adult Patients with Mild-to-Moderate Atopic Dermatitis.
It will consist of phase II and phase III parts, phase II will be a dose-ranging part and phase III will be a pivotal study part.
Detailed description
This study will evaluate the topical SHR0302 ointment, a JAK (Janus Kinase) inhibitor, in atopic dermatitis patients. The EASI (Eczema Area and Severity Index), IGA (immunoglobulin A), SCORAD (Scoring of Atopic Dermatitis),DLQI (Dermatology Life Quality Index)and NRS (Numeric Rating Score) will be applied to assesses to the efficacy, and other safety measurements will be also collected within the whole study duration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: SHR0302 Ointment Dose#1 | Active comparator | Drug: SHR0302 OintmentDrug: SHR0302 Ointment Twice a day (BID) |
| Active Comparator: SHR0302 Ointment Dose#2 | Active comparator | Drug: SHR0302 OintmentDrug: SHR0302 Ointment Twice a day (BID) |
| Active Comparator: SHR0302 Ointment Dose#3 | Active comparator | Drug: SHR0302 OintmentDrug: SHR0302 Ointment Twice a day (BID) |
| Placebo Comparator: Placebo | Placebo comparator | Drug: VehicleDrug: Vehicle Twice a day (BID) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subject at least at ≥18 and ≤75years of age at time of informed consent.
- Have mild-to- moderate AD (Atopic Dermatitis), as determined by all of the following:
- Capable of providing a signed and dated informed consent form indicating the subject has been informed of all pertinent aspect of the study
- All women of childbearing potential and all men must be willing to use at least one highly effective method of contraception from signing of informed consent, throughout the duration of the study, and for 28 days after last dose of study medication.
Key exclusion criteria (9 listed)
- Subjects currently have active forms of other skin disease (e.g., psoriasis, or lupus erythematosus) that would interfere with evaluation of the effect of study medication on atopic dermatitis, or skin infections (bacteria, fungi, or viruses), or diseases that can cause skin itching (such as itching caused by diabetes), or subjects who are allergic to topical skin drugs
- Subjects with serious concomitant illness that could require administering of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring (e.g. unstable chronic asthma)
- Subjects who have a history of mental illness or disease such as anxiety and depression, and are not suitable to participate in this study
- Subjects with serious and uncontrolled disease that may affect the safety of the subject, compliance, affect the evaluation of the endpoint, or require the use of drugs that are not allowed in the protocol
- Subjects with Human immunodeficiency virus (HIV), or hepatitis B virus ,or hepatitis C virus ,or syphilis related laboratory test positive (subjects positive for hepatitis B surface antigen, HBV (hepatitis B virus) DNA must be greater than lower limit of detection
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 |
|---|---|---|
| SHR0302 OintmentAlso: SHR0302 Ointment 2%SHR0302 Ointment Twice a day (BID) | Drug | Active Comparator: SHR0302 Ointment Dose#1 |
| SHR0302 OintmentAlso: SHR0302 Ointment 1%SHR0302 Ointment Twice a day (BID) | Drug | Active Comparator: SHR0302 Ointment Dose#2 |
| SHR0302 OintmentAlso: SHR0302 Ointment 0.5%SHR0302 Ointment Twice a day (BID) | Drug | Active Comparator: SHR0302 Ointment Dose#3 |
| VehicleAlso: PlaceboTwice a day (BID) | Drug | Placebo Comparator: Placebo |
Primary outcome
Percentage change from baseline in the eczema area and severity index (EASI) total score at Week 8
Time frame: 8 weeks
The percentage of subjects achieving the Investigator's Global Assessment（IGA）of clear (0) or almost clear (1) with a ≥2 points improvement from baseline at Week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Individual participant dataSharing planned: No
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
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
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.
Yanhong Cheng study director
Reistone Pharma
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing SHR0302 Ointment in people with Atopic Dermatitis, run by Reistone Biopharma Company Limited at 31 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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 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. 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 combined 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.
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?
Results are not available in the source record.
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?
Percentage change from baseline in the eczema area and severity index (EASI) total score at Week 8 (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2023.