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
Qualifiers
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
Treatments tested in this trial
- SHR-1819 Injection
- SHR-1819 Injection Placebo
Treatment groups
201 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov