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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Core Treatment Active Experimental: SHR0302 Dose#1 | Experimental | Drug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks |
|
| Core Treatment Active Experimental: SHR0302 Dose#2 | Experimental | Drug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks |
|
| Core Treatment Placebo Comparator: Placebo | Placebo Comparator | Drug: Placebo Oral tablets taken once daily (QD) for 16 weeks |
|
| Extension Treatment Active Experimental: SHR0302 Dose#1 | Experimental | Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks |
|
| Extension Treatment Active Experimental: SHR0302 Dose#2 | Experimental | Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Core Treatment Active Experimental: SHR0302 Dose#1 | Drug | Drug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 16 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Week 16 |
| Worst-Itch Numeric Rating Scale (WI-NRS) at Week 1, 4, 8 and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| NRS-4 at Week 24, 32, 40, 52 and 56 | Proportion of subjects achieving an improvement of WI-NRS ≥4 from baseline at all scheduled visits during extension treatment phase. | All scheduled visits from Week 24 - 56 |
| EASI 75 at Week 24, 32, 40, 52 and 56 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Research Institute Inc. | Calgary | Alberta | T2J 7E1 | Canada | ||
| Dr Chih-ho Hong Medical Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40305055 | Derived | 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. |
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| Core Treatment Active Experimental: SHR0302 Dose#2 | Drug | Drug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks |
|
| Core Treatment Placebo Comparator: Placebo | Drug | Drug: Placebo Oral tablets taken once daily (QD) for 16 weeks |
|
| Extension Treatment Active Experimental: SHR0302 Dose#1 | Drug | Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks |
|
| Extension Treatment Active Experimental: SHR0302 Dose#2 | Drug | Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks |
|
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.
| 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. | 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. | 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. | Week 1, 4, 8 and 12 |
Proportion of subjects achieving EASI 75 at all scheduled visits during extension treatment phase.
| All scheduled visits from Week 16 24 - 56 |
| IGA 0/1 at Week 24, 32, 40, 52 and 56 | Proportion of subjects achieving IGA0/1 and a reduction from baseline of ≥2 points at all scheduled visits during extension treatment phase. | All scheduled visits from Week 24 - 56 |
| EASI 50 and EASI 90 at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 56 | Proportion of subjects with ≥50% EASI improvement from baseline (EASI 50) at all scheduled visits. | Day 1 to Week 56 |
| Change of EASI from baseline at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 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. | Day 1 to Week 56 |
| SCORAD 50, SCORAD 75 and SCORAD 90 at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 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. | Day 1 to Week 56 |
| Change of SCORAD from baseline at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 56 | Change from baseline in SCORAD at all scheduled visits | Day 1 to Week 56 |
| Change of BSA from baseline at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 56 | Change from baseline in body surface area (BSA) affected at all scheduled visits | Day 1 to Week 56 |
| Change of IgE from baseline at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 56 | Change from baseline in the level of serum IgE in peripheral blood at all scheduled visits. | Day 1 to Week 56 |
| Change of eosinophils from baseline at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 56 | Change from baseline in the level of serum eosinophils in peripheral blood at all scheduled visits. | Day 1 to Week 56 |
| 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 | 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. | Day 1 to Week 56 |
| Change of Patient-Oriented Eczema Measure (POEM) from baseline at Week 4, 8, 12, 16, 24, 32, 40, 52 and 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. | Day 1 to Week 56 |
| Surrey |
| British Columbia |
| V3R 6A7 |
| Canada |
| Enverus Medical Research | Surrey | British Columbia | V3V 0C6 | Canada |
| Wiseman Dermatology Research | Winnipeg | Manitoba | R3M 3Z4 | Canada |
| CCA Medical Research | Ajax | Ontario | L1S 7K8 | Canada |
| SKiN Health | Cobourg | Ontario | K9A 0Z4 | Canada |
| DermEffects | London | Ontario | N6H 5L5 | Canada |
| North York Research Inc. | North York | Ontario | M2M 4J5 | Canada |
| The Centre for Dermatology | Richmond Hill | Ontario | L4B 1A5 | Canada |
| York Dermatology | Richmond Hill | Ontario | L4C 9M7 | Canada |
| Toronto Research Centre | Toronto | Ontario | M3H 5Y8 | Canada |
| Research Toronto | Toronto | Ontario | M4W 2N4 | Canada |
| AvantDerm | Toronto | Ontario | M5A 3R6 | Canada |
| XLR8 Clinical Research | Windsor | Ontario | N8W 1E6 | Canada |
| Clinique D | Laval | Quebec | H7N 6L2 | Canada |
| First Affiliated Hospital of Anhui Medical University | Hefei | Anhui | China |
| The second Affiliated Hospital of Anhui Medical University | Hefei | Anhui | China |
| Peking University People's Hospital | Beijing | Beiing | 100044 | China |
| First Affiliated Hospital of Fujian Medical University | Fuzhou | Fujian | China |
| Zhongshan Hospital, Fudan University(Xiamen Branch) | Xiamen | Fujian | China |
| Dermatology Hospital of Southern Medical University | Guangzhou | Guangdong | China |
| Guangdong Province Traditional Chinese Medical Hospital | Guangzhou | Guangdong | China |
| The First affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | China |
| Wuhan No.1 Hospital | Wuhan | Hubei | China |
| Xiangya Hospital of Central South University | Changsha | Hunan | 410008 | China |
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | China |
| Hospital for Skin Diseases, Chinese Academy of medical sciences | Nanjing | Jiangsu | China |
| Jiangsu province people's hospital | Nanjing | Jiangsu | China |
| Wuxi No.2 People's Hospital | Wuxi | Jiangsu | China |
| Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu | China |
| Jiangxi Provincial Hospital of Dermatology | Nanchang | Jiangxi | China |
| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | China |
| The second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | China |
| The first hospital of jilin university | Changchun | Jilin | China |
| West China Hospital of Sichuan University | Chengdu | Sichuan | China |
| Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital | Tianjin | Tianjin Municipality | 300120 | China |
| The First Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310003 | China |
| The Children's Hospital Affiliated to Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
| The first people's hospital of hangzhou | Hangzhou | Zhejiang | China |
| The fourth hospital affiliated to zhejiang university school of medicine | Yiwu | Zhejiang | China |
| Beijing Children's Hospital, Capital Medical University | Beijing | 100045 | China |
| Peking University third hospital | Beijing | 100191 | China |
| Peking union medical college hospital | Beijing | 100730 | China |
| Children's Hospital Capital Institute of Pediatrics | Beijing | China |
| The Third Xiangya Hospital of Central South University | Changsha | 410013 | China |
| Chongqing Traditional Chinese medicine Hospital | Chongqing | China |
| First affiliated hospital of chongqing medical university | Chongqing | China |
| The Southwest Hospital of AMU | Chongqing | China |
| Zhejiang province People's Hospital | Hangzhou | 310014 | China |
| Dermatology hospital of Shanghai | Shanghai | China |
| Huashan Hospital Affiliated to Fudan University | Shanghai | China |
| The first hospital of China medical university | Shenyang | 110001 | China |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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