A Study of SHR-1819 Injection in Adolescents With Severe Atopic Dermatitis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-17
SponsorGuangdong Hengrui Pharmaceutical Co., Ltd
About this trial
This trial was designed to evaluate the efficacy and safety of SHR-1819 in adolescents with moderate-to-severe atopic dermatitis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female ≥12 to ≤17 years of age at time of screening visit, body weight ≥30kg;
Diagnosis of Atopic Dermatitis (AD) at least 6 months prior to the screening visit according to the American Academy of Dermatology consensus criteria (Eichenfield 2014);
Diagnosis of moderate to severe AD at the screening visit and baseline visits meet all of the following 3 criteria simultaneously: EASI ≥16, IGA ≥3, BSA≥10%;
Baseline Pruritus Numerical Rating Scale (NRS) average score for maximum itch intensity ≥4 (A minimum of 5 daily scores out of the 7 days is required to calculate the baseline average score);
Disqualifiers
Has other active skin diseases (e.g., psoriasis or systemic lupus erythematosus) that may affect AD assessment, or skin complications caused by other diseases at screening visit;
Has a history of vernal keratoconjunctivitis (VKC) and/or atopic keratoconjunctivitis (AKC) within 6 months prior to screening visit;
Has received any of the following medications within 1 week prior to randomization: a) Topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI); b) Topical traditional Chinese medicine (TCM) for atopic dermatitis; c) Other topical medications with therapeutic effects on AD (including but not limited to topical phosphodiesterase-4 [PDE-4] inhibitors, topical JAK inhibitors, etc.); d) Emollients containing active ingredients (e.g., ceramide, hyaluronic acid, urea, or filaggrin breakdown products); e) Leukotriene inhibitors (Note: If the participant is not taking such medications orally at randomization, they must have been off oral administration for at least 1 week prior to randomization; if the participant is taking such medications orally at randomization, they must have received stable-dose treatment for ≥2 weeks prior to randomization and continue stable use throughout the study period);
Has received ≥2 bleach baths within 2 weeks prior to randomization;
Trial design
Design model
Parallel
Treatments tested in this trial
SHR-1819 Injection
DrugSHR-1819 injection.
SHR-1819 Injection Placebo
DrugSHR-1819 injection placebo.
Treatment groups
201 Participants
are divided into 4 treatment groupsGroup A: SHR-1819 Injection Group with Dose 1Experimental treatment 1 intervention
Group B: SHR-1819 Injection Placebo Group with Dose 1Placebo comparator 1 intervention
Group C: SHR-1819 Injection Group with Dose 2Experimental treatment 1 intervention
Group D: SHR-1819 Injection Placebo Group with Dose 2Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of patients with Eczema Area and Severity (EASI)-75.
EASI-75: ≥ 75% improvement from baseline.
Time frame
At week 16.2
Proportion of patients with an Investigator's Global Assessment (IGA) score of either 0 or 1.
On a 5-point scale.
Time frame
At week 16.Secondary outcomes
1
Proportion of patients with improvement (reduction) of weekly average of daily peak Pruritus Numerical Rating Scale (NRS) ≥ 4 from baseline to week 16.
Time frame
From baseline up to week 16.2
Proportion of patients with Eczema Area and Severity (EASI)-90.
EASI-90: ≥ 90% improvement from baseline.
Time frame
At week 16.3
Proportion of participants achieving EASI-75 at week 1, 2, 4, 8, 12, 20, then every 4 weeks;
Time frame
at week 1, 2, 4, 8, 12, 20, then every 4 weeks;4
Proportion of participants with an IGA score of 0 or 1.
Time frame
at week 1, 2, 4, 8, 12, 20, then every 4 weeks;Sponsors and contacts
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Source ClinicalTrials.gov