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The primary objective of the study was to evaluate the safety and tolerability of 611 in chinese adults with moderate to severe atopic dermatitis.
The maximum study duration was 30 weeks per participants, including a screening period of up to 2 weeks, a 4-weeks single dose treatment period, and then a 16-weeks repeated dose treatment period, and an 8-week follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 611 dose 1 plus placebo | Experimental | One subcutaneous injections of 611 150 mg on Day 1, followed by a 4-week observation period. Two subcutaneous injections of 611 150 mg (for a total of 300 mg) as a loading dose on Week 0 Day 29, followed by one 150 mg injection quaque week (QW) from Week 1 to Week 15 (15 cycles). |
|
| 611 dose 2 plus placebo | Experimental | Two subcutaneous injections of 611 150 mg (for a total of 300 mg) on Day 1, followed by a 4-week observation period. Four subcutaneous injections of 611 150 mg (for a total of 600 mg) as a loading dose on Week 0 Day 29, followed by one 300 mg injection quaque 2 week (Q2W) from Week 1 to Week 15 (8 cycles). |
|
| 611 dose 3 plus placebo | Experimental | Four subcutaneous injections of 611 150 mg (for a total of 600 mg) on Day 1, followed by a 4-week observation period. Four subcutaneous injections of 611 150 mg (for a total of 600 mg) as a loading dose on Week 0 Day 29, followed by one 300 mg injection QW from Week 1 to Week 15 (15 cycles). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 611 150mg | Drug | subcutaneous injection, 150 mg (single dose treatment period) + 300mg (loading dose, week 0) + 150mg QW (maintenance dose, from Week 1 to Week 15, 15 cycles) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 (Day 197). |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Concentration (Cmax). | Maximum Observed Serum Concentration (Cmax) of 611 | Baseline to Week 24 (Day 197). |
| Minimum concentration (Cmin). | Minimum concentration (Cmin) of 611. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xinghua Gao, MD | The First of Hospital China Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Wannan Medical College | Wuhu | Anhui | 241001 | China | ||
| Peking University Shougang Hospital |
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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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| ID | Term |
|---|---|
| C071192 | entacapone |
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| 611 300mg | Drug | subcutaneous injection, 300 mg (single dose treatment period) + 600mg (loading dose, week 0) + 300mg Q2W (maintenance dose, from Week 1 to Week 15, 8 cycles) |
|
| 611 600mg | Drug | subcutaneous injection, 600 mg (single dose treatment period) + 600mg (loading dose, week 0) + 300mg QW (maintenance dose, from Week 1 to Week 15, 15 cycles) |
|
| Placebo | Other | During the study, placebos shall be filled timely according to the administration of the test drug to ensure the consistency of the times of administration in each group, so as to maintain the blind state. |
|
| Baseline to Week 24 (Day 197). |
| Time to Reach the Maximum Concentration (Tmax). | Time to Reach the Maximum Serum Concentration (Tmax) of 611. | Baseline to Week 24 (Day 197). |
| 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 (Day 197). |
| 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 (Day 197). |
| Clearance rate (CL/F). | Clearance rate (CL/F) of 611. | Baseline to Week 24 (Day 197). |
| 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 (Day 197). |
| 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 at Week 8(Day 85), Week 12(Day 113), Week 16(Day 141). | 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 , Week 8(Day 85), Week 12(Day 113), Week 16(Day 141). |
| Number of Participants With Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Improvement in Score From Baseline) at Week 8(Day 85), Week 12(Day 113), Week 16(Day 141). | 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 8(Day 85), Week 12(Day 113), Week 16(Day 141). |
| Percentage Change 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 , Week 8(Day 85), Week 12(Day 113), Week 16(Day 141). |
| Percentage Change 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 , Week 8(Day 85), Week 12(Day 113), Week 16(Day 141). |
| Number of Participants Who Achieved >=4 Points With Improvement From Baseline in Weekly Average of Pruritus Numerical Rating Scale (NRS) Score at Week 8(Day 85), Week 12(Day 113), Week 16(Day 141). | 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 , Week 8(Day 85), Week 12(Day 113), Week 16(Day 141). |
| Change in serum concentrations of Thymus and activation regulated chemokine (TARC) | Change in serum concentrations of TARC | Baseline to Week 24 (Day 197). |
| Change in serum concentrations of immunoglobulin E (IgE) | Change in serum concentrations of IgE. | Baseline to Week 24 (Day 197). |
| Change in whole blood eosinophil counts | Change in whole blood eosinophil counts. | Baseline to Week 24 (Day 197). |
| Change in serum concentrations of lactate dehydrogenase (LDH) | Change in serum concentrations of lactate dehydrogenase (LDH). | Baseline to Week 24 (Day 197). |
| Beijing |
| Beijing Municipality |
| 100144 |
| China |
| Nanyang First People's Hospital | Nanyang | Henan | 473010 | China |
| Dermatology Hospital of Jiangxi Province | Nanchang | Jiangxi | 330001 | China |
| The First of Hospital China Medical University | Shenyang | Liaoning | 110001 | China |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |