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The primary objective of the study was to evaluate the efficacy and safety of 611 in chinese adults with moderate to severe atopic dermatitis.
The maximum study duration was 28 weeks per participants, including a screening period of up to 4 weeks, a 16-week randomized treatment period, and a 8-week follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 611 Q2W | Experimental | Four subcutaneous injections of 611 150 mg (for a total of 600 mg) as a loading dose on Week 0 Day 1, followed by two 150 mg injections (for a total of 300 mg) q2w from Week 2 to Week 14 (7 cycles). |
|
| 611 Q4W | Experimental | Four subcutaneous injections of 611 150 mg (for a total of 600 mg) as a loading dose on week 0 Day 1, followed by two 150 mg injections (for a total of 300 mg) q4w on week 4, 8, 12 and two injections of placebo on week 2, 6, 10, 14. |
|
| placebo | Placebo Comparator | Four subcutaneous injections of placebo as a loading dose on week 0 Day 1, followed by two injections q2w from Week 2 to Week 14 (7 cycles). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 611 Q2W | Drug | subcutaneous injection, 600mg (loading dose, week 0) + 300mg Q2W (maintenance dose, from Week 2 to Week 14, 7 cycles) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Improvement in Score From Baseline) at Week 16 | The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. | Baseline, Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With EASI-50 (>=50% Improvement From Baseline) at Week 16 | The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | Beijing Municipality | 100044 | China | ||
| Dermatology Hospital of Southern Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40057938 | Derived | Zhao Y, Zhang L, Wu L, Duan X, Ji C, Xiao R, Ji M, Liu L, Yang B, Hu G, Feng Y, Zhu J, Li J, Ding Y, Huang H, Zhou Q, Xu Y, Zhang J. Efficacy and Safety of 611 in Chinese Adults with Moderate-to-Severe Atopic Dermatitis: Results from a Phase II Trial. Dermatol Ther (Heidelb). 2025 Apr;15(4):857-867. doi: 10.1007/s13555-025-01368-4. Epub 2025 Mar 9. |
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| 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 |
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| 611 Q4W | Drug | subcutaneous injection, 600mg (loading dose, Day1) + 300mg Q4W (maintenance dose, on week 4, 8, 12) + placebo Q4W (on week 2, 6, 10, 14) |
|
| Matching placebo | Drug | subcutaneous injection, Q2W, from Week 2 to Week 14, 7 cycles |
|
|
| Baseline, Week 16 |
| Number of Participants With EASI-90 (>=90% Improvement From Baseline) at Week 16 | The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. | Baseline, Week 16 |
| Number of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Improvement From Baseline of Greater Than or Equal to (>=) 2 Points From Baseline to Week 16 | The IGA is an assessment instrument used to rate the severity of AD globally based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity. | Baseline to Week 16 |
| Number of Participants Who Achieve Improvement of IGA Score by >=2 From Baseline to Week 16 | The IGA is an assessment instrument used to rate the severity of AD globally based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity. | Baseline to Week 16 |
| Number of Participants Who Achieved >=4 Points With Improvement From Baseline in Weekly Average of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16 | Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]), higher scores indicated greater severity. | Baseline to Week 16 |
| Number of Participants Who Achieved >=3 Points With Improvement From Baseline in Weekly Average of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16 | Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]), higher scores indicated greater severity. | Baseline to Week 16 |
| Percentage Change From Baseline to Week 16 in EASI Score | The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. | Baseline to Week 16 |
| Change From Baseline to Week 16 in Percent Body Surface Area (BSA) of AD Involvement | BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]) and reported as a percentage of all major body sections combined. The reported percentage of BSA was combined percentage of all major body sections. | Baseline to Week 16 |
| Change From Baseline at Week 16 in Weekly Average of Pruritus NRS | Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]), higher scores indicated greater severity. | Baseline to Week 16 |
| Change From Baseline to Week 16 in Dermatology Life Quality Index (DLQI) Total Score | The DLQI was a validated questionnaire used to measure the impact of AD disease symptoms and treatment on health-related quality of life (QOL). DLQI consisting of a set of 10 questions which assess QOL over the past week. Responses to each questions were assessed on a scale of 0 to 3, where 0 is "not at all" and 3 is "very much". Scores from all 10 questions added up to give total DLQI scores ranged from 0 (not at all) to 30 (very much), higher scores indicated more impact on quality of life. | Baseline to Week 16 |
| Change From Baseline to Week 16 in Patient Oriented Eczema Measure (POEM) | The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a scale ranging from 0 to 4 (0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, 4 = all days). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). Higher scores indicated more severe disease and poor quality of life. | Baseline to Week 16 |
| Adverse events (AEs), measurement of vital signs,physical examination,electrocardiogram and laboratory tests at each visit. | The incidence and severity of treatment emergent adverse event (TEAE), including Serious Adverse Event (SAE), as well as clinical symptoms, and any abnormalities of vital signs, physical examinations,electrocardiogram,laboratory tests and, etc. | Up to 24 Weeks |
| Maximum Concentration (Cmax). | Maximum Observed Serum Concentration (Cmax) of 611 | Baseline to Week 24. |
| Minimum concentration (Cmin). | Minimum concentration (Cmin) of 611. | Baseline to Week 24. |
| Time to Reach the Maximum Concentration (Tmax). | Time to Reach the Maximum Serum Concentration (Tmax) of 611. | Baseline to Week 24. |
| Area under the serum concentration-time curve from 0 to the time of the last quantifiable concentration (AUC0-last). | Area under the serum concentration-time curve from 0 to the time of the last quantifiable concentration (AUC0-last) of 611. | Baseline to Week 24. |
| AUC to the end of the dosing period (AUC0-tau) | AUC to the end of the dosing period (AUC0-tau) of 611. | Baseline to Week 24. |
| Clearance rate (CL/F). | Clearance rate (CL/F) of 611. | Baseline to Week 24. |
| Percentage of Participants With Anti-drug Antibodies and Neutralizing Antibodies. | Immunogenicity assessment will be based on Anti-drug Antibodies (ADAs) response and development of Neutralizing Antibodies (NABs). Percentage is calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-drug antibodies / number of evaluable participants * 100%. | Baseline to Week 24. |
| Change in serum concentrations of Thymus and activation regulated chemokine (TARC) | Change in serum concentrations of TARC | Baseline to Week 24. |
| Change in serum concentrations of IL-4 | Change in serum concentrations of IL-4 | Baseline to Week 24. |
| Change in serum concentrations of IL-13 | Change in serum concentrations of IL-13. | Baseline to Week 24. |
| Change in serum concentrations of IgE | Change in serum concentrations of IgE. | Baseline to Week 24. |
| Change in whole blood eosinophil counts | Change in whole blood eosinophil counts. | Baseline to Week 24. |
| Change in serum concentrations of lactate dehydrogenase (LDH) | Change in serum concentrations of lactate dehydrogenase (LDH). | Baseline to Week 24. |
| Guangzhou |
| Guangdong |
| 510091 |
| China |
| Dermatology Hospital of Jiangxi Province | Nanchang | Jiangxi | 330200 | China |
| Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310003 | China |
| The Fourth Affiliated Hospital Zhejiang University School of Medicine | Jinhua | Zhejiang | 322000 | China |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |