Atopic Dermatitis
Conditions
Brief summary
This study will evaluate the efficacy and safety of SIM0718 in adolescents (12- \< 18 years) and adults (18-75 years) with moderate to severe AD.
Detailed description
This is a randomized, double-blind, placebo-controlled multicenter clinical study to evaluate the efficacy and safety of SIM0718 in adolescents (12- \< 18 years) and adults (18-75 years) with moderate to severe AD. Subjects who meet entry criteria will be randomized to receive either SIM0718 or matching placebo.The study includes a screening period, a treatment period and a follow-up period.
Interventions
BIOLOGICALSIM0718 Injection
Subjects who meet entry criteria will be randomized in a 1:1 ratio to receive either SIM0718 or matching placebo,Q2W, SC until Week 16. At the Week 16 visit, subjects in the placebo group will be transferred to SIM0718 300 mg Q2W after completing safety and efficacy assessments. Subjects who were originally treated with 300 mg Q2W of SIM0718 will continue on their original treatment regimen.
Sponsors
Simcere Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 12 and ≤ 75 years, male or female, and body weight ≥ 40 kg at the screening visit. 2. Diagnosis of atopic dermatitis at screening (according to the American Academy of Dermatology Concordance Criteria, 2014), and: 1) Adult diagnosed AD for ≥ 12 months and adolescent diagnosed AD for ≥ 6 months prior to screening; 2) Inadequate response or intolerance to topical medications, or is medically inappropriate for topical treatment judged by the investigator within 6 months prior to Screening; 3) At Screening and Baseline,IGA score ≥3; 4)At Screening and Baseline, EASI score ≥ 16; 5) At Screening and Baseline,total AD involvement ≥ 10% BSA; 6) Baseline peak pruritus NRS score ≥ 4.
Exclusion criteria
1. Not enough washing-out period for previous therapy. 2. History of any of the following: 1\) History of significant immune reactions (eg, serum sickness, anaphylaxis, or delayed hypersensitivity) to any other biologic agent or any excipient of SIM0718; 2) Presence of other active skin comorbidities other than AD that may interfere with study assessments, such as scabies, skin lymphoma, or psoriasis; 3) Active keratoconjunctivitis and atopic keratoconjunctivitis at screening; or previous history of recurrent keratoconjunctivitis and atopic keratoconjunctivitis; 4) Patients with active tuberculosis (TB), latent TB, or a history of nontuberculous mycobacterial infection at screening; 5) HBsAg positive at screening; or HBcAb positive with HBV-DNA positive; or hepatitis C antibody positive with HCV RNA polymerase chain reaction positive; or HIV serology positive; 6) Systemic treatment with antibiotics, antivirals, antiparasitic agents, antiprotozoal agents, or antifungal agents for infections within 4 weeks prior to baseline, or superficial skin infections within 1 week prior to baseline that could interfere with study assessments (subjects could be re-screened after resolution of infection); 7) History of parasitic infection within 6 months prior to baseline; 8) According to the investigator 's judgment, known or suspected history of immunosuppression within 6 months prior to baseline, including but not limited to history of invasive opportunistic infections, such as aspergillosis, coccidioidomycosis, histoplasmosis, HIV, listeriosis, pneumocystis disease or tuberculosis; or the presence of abnormal frequent recurrent or persistent infections; 9) History of malignancy within 5 years prior to screening. 3\. Planned major surgical procedures during the study. 4\. History of alcohol or drug abuse within 2 years before screening. 5\. Any other condition that, in the judgment of the investigator, would make participation in this study inappropriate. 6\. Female subjects of childbearing potential, who experience any of the following * Positive serum pregnancy test or positive urine pregnancy test before baseline * Pregnant or breastfeeding women, or women planning to become pregnant or breastfeeding during the study who are unwilling to use at least one highly effective form of birth control throughout the study and for 90 days after the last dose of study drug.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EASI-75 at week 16 | Day1-Week16 | Proportion of subjects achieving EASI-75 at week 16. |
| IGA score at week 16 | Day1-Week16 | Proportion of subjects with IGA score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline at week 16. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EASI-75 at each visit | Day1-Week52 | Proportion of subjects achieving EASI-75 at each visit |
| EASI-50 at each visit | Day1-Week52 | Proportion of subjects achieving EASI-50 at each visit |
| EASI-90 at each visit | Day1-Week52 | Proportion of subjects achieving EASI-90 at each visit |
| NRS score | Day1-Week52 | Percent change of NRS score from baseline |
| BSA | Day1-Week52 | Body surface area (BSA) of involvement of atopic dermatitis |
| DLQI | Day1-Week52 | Changes from baseline in Dermatology Life Quality Index (DLQI) |
| Incidence of adverse events (AEs) | Day1-Week60 | Incidence of adverse events (AEs), abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORJianzhong Zhang
Peking University People's Hospital
PRINCIPAL_INVESTIGATORCheng Zhou
Peking University People's Hospital
Outcome results
None listed