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This trial was designed to evaluate the efficacy and safety of SHR-1819 injection in patients with atopic dermatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A: SHR-1819 | Experimental |
| |
| Treatment group B: SHR-1819 | Experimental |
| |
| Treatment group C: SHR-1819 | Experimental |
| |
| Treatment group D: placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1819 | Drug | Treatment group A: SHR-1819 injection dose 1; Treatment group B: SHR-1819 injection dose 2; Treatment group C:SHR-1819 injection dose 3. |
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| Measure | Description | Time Frame |
|---|---|---|
| At 16 weeks, the proportion of subjects who achieved eczema area and severity index (EASI) -75 (EASI score decreased ≥ 75% from baseline) | EASI sore use EASI scale | Up to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| At week 16, the proportion of participants with an overall investigator assessment (IGA) score of 0 or 1 (0-4 scale) and a decrease of ≥ 2 points from baseline | The overall degree of improvement was assessed using the IGA scale | Up to 16 weeks |
| At week 16, the proportion of subjects whose IGA score decreased from baseline by ≥ 2 points |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Sub-Hospital of Fudan University | Shanghai | Shanghai Municipality | 200040 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42210243 | Derived | Gu C, Yin H, Yang B, Ji S, Bian K, Man X, Lu J, Sui D, Zhou Y, Cheng F, Xu A, Li X, Jiang M, Diao Q, Ji C, Shi T, Ding Y, Ren H, Li Y, Liu H, Meng Z, Feng P, Zhang S, Bai X, Li P, Dong Y, Liu S, Zhang C, Xu J. Anti-IL-4Ralpha antibody SHR-1819 for moderate-to-severe atopic dermatitis: a randomized phase 2 study. BMC Med. 2026 May 28. doi: 10.1186/s12916-026-04952-3. Online ahead of print. |
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| Placebo | Drug | Treatment group D: placebo |
|
The overall degree of improvement was assessed using the IGA scale |
| Up to 16 weeks |
| At week 16, the proportion of subjects who achieved EASI-90 (EASI score ≥ 90% lower than baseline) | The extent of area is assessed using the EASI scale | Up to 16 weeks |
| At week 16, the percentage of subjects who achieved EASI-50 (EASI score ≥ 50% lower than baseline) | The extent of area is assessed using the EASI scale | Up to 16 weeks |
| At week 16, the weekly average of the daily peak itching (itch) digital evaluation scale (P-NRS) decreased from baseline by ≥ 4 points | The extent of pruritus is assessed using the P-NRS scale | Up to 16 weeks |
| At week 16, EASI is the percentage change from baseline and change | The extent of area is assessed using the EASI scale | Up to 16 weeks |
| At week 16, the atopic dermatitis score (SCORAD) was the percentage change from baseline and change | The extent of lesions and pruritus is assessed using the SCORAD scale | Up to 16 weeks |
| At week 16, atopic dermatitis affects the body surface area (BSA) as a percentage of the baseline change and change | The BSA scale was used to assess improvement in lesion area | Up to 16 weeks |
| At week 16, the Dermatological Quality of Life Scale (DLQI) score was a percentage change from baseline and change | The quality of Life is assessed using the DLQI scale | Up to 16 weeks |
| The incidence of adverse events ranged from the first dose to 24 weeks | Assess the post-medication safety of subjects from the first dose to the time they exit the group | From the beginning of administration to the 24th week |
| Concentration of SHR-1819 in serum | From the beginning of administration to the 24th week |
| Changes of TARC/CCL17 in the serum | From the beginning of administration to the 24th week |
| Changes of IgE in the serum | From the beginning of administration to the 24th week |
| Changes of eotaxin-3 in the serum | From the beginning of administration to the 24th week |
| Immunogenicity of SHR-1819 | From the beginning of administration to the 24th week |