The primary objective of the study was to evaluate the efficacy of 611 in Chinese adults with moderate to severe atopic dermatitis.
The maximum study duration was 64 weeks per participants, including a screening period of up to 4 weeks, a 52-week treatment period, and an 8-week follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
519
subcutaneous injection
subcutaneous injection
Peking University People's Hospital
Beijing, Beijing Municipality, China
Dermatology Hospital of Jiangxi Province
Nanchang, Jiangxi, China
Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The Fourth Affiliated Hospital Zhejiang University School of Medicine
Jinhua, Zhejiang, China
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.
Time frame: 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.
Time frame: Baseline，Week 16
Number of Participants With EASI-50 (>=50% Improvement From Baseline)
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.
Time frame: Baseline to Week 60
Number of Participants With EASI-90 (>=90% Improvement From Baseline)
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.
Time frame: Baseline to Week 60
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Number of Participants Who Achieved >=4 Points/ >=3 Points With Improvement From Baseline in Weekly Average of Pruritus Numerical Rating Scale (NRS) Score From Baseline
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.
Time frame: Baseline to Week 60
Percentage Change From Baseline 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.
Time frame: Baseline to Week 60
Change From Baseline 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，with the higher scores reflecting the worse severity of AD.
Time frame: Baseline to Week 60
Change From Baseline 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.
Time frame: Baseline to Week 60
Change From Baseline 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.
Time frame: Baseline to Week 60
Change From Baseline 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.
Time frame: Baseline to Week 60
Percentage of patients having achieved EASI-75 at Week 16 who continue to exhibit EASI-75 at Week 52 (EASI-75 calculated relative to baseline 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.
Time frame: Baseline to Week 52
Percentage of patients having achieved IGA 0 or 1 and a ≥2-point improvement from Baseline at Week 16 who continue to exhibit an IGA 0 or 1 and a ≥2-point improvement from Baseline at Week 52
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.
Time frame: Baseline to Week 52
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.
Time frame: Up to 60 Weeks
Minimum concentration (Cmin)
Minimum concentration (Cmin) of 611
Time frame: Baseline to Week 60
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%.
Time frame: Baseline to Week 60.
Change in serum concentrations of Pharmacodynamics indicators.
Pharmacodynamics indicators.
Time frame: Baseline to Week 60.