Evaluate Efficacy and Safety of Oral SHR0302 in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis
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| ClinicalTrials.gov Identifier: NCT04875169 |
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Recruitment Status :
Recruiting
First Posted : May 6, 2021
Last Update Posted : May 6, 2021
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Sponsor:
Reistone Biopharma Company Limited
Information provided by (Responsible Party):
Reistone Biopharma Company Limited
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Atopic Dermatitis | Drug: Core Treatment Active Experimental: SHR0302 Dose#1 Drug: Core Treatment Active Experimental: SHR0302 Dose#2 Drug: Core Treatment Placebo Comparator: Placebo Drug: Extension Treatment Active Experimental: SHR0302 Dose#1 Drug: Extension Treatment Active Experimental: SHR0302 Dose#2 | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 330 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 3 Study to Evaluate Efficacy and Safety of Oral SHR0302 in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis |
| Estimated Study Start Date : | April 30, 2021 |
| Estimated Primary Completion Date : | June 30, 2023 |
| Estimated Study Completion Date : | June 30, 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Atopic dermatitis
MedlinePlus related topics:
Eczema
| Arm | Intervention/treatment |
|---|---|
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Experimental: Core Treatment Active Experimental: SHR0302 Dose#1
Drug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks
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Drug: Core Treatment Active Experimental: SHR0302 Dose#1
Drug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks |
|
Experimental: Core Treatment Active Experimental: SHR0302 Dose#2
Drug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks
|
Drug: Core Treatment Active Experimental: SHR0302 Dose#2
Drug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks |
|
Placebo Comparator: Core Treatment Placebo Comparator: Placebo
Drug: Placebo Oral tablets taken once daily (QD) for 16 weeks
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Drug: Core Treatment Placebo Comparator: Placebo
Drug: Placebo Oral tablets taken once daily (QD) for 16 weeks |
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Experimental: Extension Treatment Active Experimental: SHR0302 Dose#1
Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks
|
Drug: Extension Treatment Active Experimental: SHR0302 Dose#1
Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks |
|
Experimental: Extension Treatment Active Experimental: SHR0302 Dose#2
Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks
|
Drug: Extension Treatment Active Experimental: SHR0302 Dose#2
Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- Worst-Itch Numeric Rating Scale (WI-NRS-4)-4 at Week 16 [ Time Frame: Week 16 ]Proportion of subjects achieving an improvement of Worst-Itch Numeric Rating Scale (WI-NRS) ≥4 from baseline at Week 16
- Worst-Itch Numeric Rating Scale (WI-NRS) at Week 1, 4, 8 and 12 [ Time Frame: 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.
- Time to WI-NRS response [ Time Frame: Baseline to Week 16 ]Time from baseline to achieve at least 4 points improvement of WI-NRS during placebo-controlled treatment phase.
- EASI 75 at Week 1, 4, 8 and 12 [ Time Frame: Week 1, 4, 8 and 12 ]Proportion of subjects achieving EASI 75 at all scheduled visits during placebo-controlled treatment phase except Week 16.
- IGA 0/1 at Week 1, 4, 8 and 12 [ Time Frame: 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.
Other Outcome Measures:
- NRS-4 at Week 24, 32, 40, 52 and 56 [ Time Frame: All scheduled visits from Week 24 - 56 ]Proportion of subjects achieving an improvement of WI-NRS ≥4 from baseline at all scheduled visits during extension treatment phase.
- EASI 75 at Week 24, 32, 40, 52 and 56 [ Time Frame: All scheduled visits from Week 16 24 - 56 ]Proportion of subjects achieving EASI 75 at all scheduled visits during extension treatment phase.
- IGA 0/1 at Week 24, 32, 40, 52 and 56 [ Time Frame: All scheduled visits from Week 24 - 56 ]Proportion of subjects achieving IGA0/1 and a reduction from baseline of ≥2 points at all scheduled visits during extension treatment phase.
- EASI 50 and EASI 90 at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 56 [ Time Frame: Day 1 to Week 56 ]Proportion of subjects with ≥50% EASI improvement from baseline (EASI 50) at all scheduled visits.
- Change of EASI from baseline at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 56 [ Time Frame: Day 1 to Week 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.
- SCORAD 50, SCORAD 75 and SCORAD 90 at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 56 [ Time Frame: Day 1 to Week 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.
- Change of SCORAD from baseline at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 56 [ Time Frame: Day 1 to Week 56 ]Change from baseline in SCORAD at all scheduled visits
- Change of BSA from baseline at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 56 [ Time Frame: Day 1 to Week 56 ]Change from baseline in body surface area (BSA) affected at all scheduled visits
- Change of IgE from baseline at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 56 [ Time Frame: Day 1 to Week 56 ]Change from baseline in the level of serum IgE in peripheral blood at all scheduled visits.
- Change of eosinophils from baseline at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 56 [ Time Frame: Day 1 to Week 56 ]Change from baseline in the level of serum eosinophils in peripheral blood at all scheduled visits.
- 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 [ Time Frame: Day 1 to Week 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.
- Change of Patient-Oriented Eczema Measure (POEM) from baseline at Week 4, 8, 12, 16, 24, 32, 40, 52 and 56 [ Time Frame: Day 1 to Week 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.
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| Ages Eligible for Study: | 12 Years to 75 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04875169
Contacts
| Contact: Imran Ghiasuddin | 8472937866 | imran.ghiasuddin@reistonebio.com | |
| Contact: Wenfeng Wu | wenfeng.wu@reistonebio.com |
Locations
Show 44 study locations
Sponsors and Collaborators
Reistone Biopharma Company Limited
| Responsible Party: | Reistone Biopharma Company Limited |
| ClinicalTrials.gov Identifier: | NCT04875169 |
| Other Study ID Numbers: |
RSJ10333 |
| First Posted: | May 6, 2021 Key Record Dates |
| Last Update Posted: | May 6, 2021 |
| Last Verified: | April 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Dermatitis, Atopic Dermatitis Eczema Skin Diseases Skin Diseases, Genetic |
Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |