A Phase 2 Study to Evaluate the Efficacy, Safety of SIM0278 in Subjects With Moderate to Severe Atopic Dermatitis

Not Applicable

Not yet recruiting

• Conditions: Atopic Dermatitis (AD)
• Interventions: Drug: SIM0278 injection; Other: Placebo

• Registration Number: NCT07175233
• Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

Brief Summary

This is a randomized, double-blind, placebo-controlled multicenter clinical study to evaluate the efficacy, safety, and pharmacokinetics of SIM0278 in adult patients (18-75 years) with moderate to severe AD suitable for systemic therapy.

Approximately 184 subjects with moderate to severe AD are planned to be randomized in a 1: 1: 1: 1 ratio to SIM0278 low dose, SIM0278 medium dose, SIM0278 high dose, or placebo. Subjects were stratified at randomization by baseline disease severity (moderate \[IGA = 3\] VS severe \[IGA = 4\]).

The study consisted of 4 phases: screening, double-blind induction, open-label maintenance, and safety follow-up.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-09
• Study First Submitted QC: 2025-09-09
• Study First Posted: 2025-09-16
• Last Update Submitted: 2025-09-18
• Last Update Posted: 2025-09-23
• Study Start: 2025-10-27
• Primary Completion: 2026-08-15
• Study Completion: 2027-08-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

1. Atopic dermatitis was diagnosed at screening (according to the American Academy of Dermatology consensus criteria for atopic dermatitis, 2014);
2. Use of a stable dose of emollients at least twice daily at sites of AD involvement starting at least 7 days prior to baseline;Alternatively, if the subject is using a prescribed emollients or moisturizers containing ceramide, urea, filaggrin degradation products, or hyaluronic acid prior to the Screening Visit, they may continue in the study but require a stable dose at least twice daily at the AD affected site starting at least 7 days prior to baseline;
3. Female and male subjects are willing to use protocol-required contraception from the Screening Visit until at least 90 days after the last dose and do not plan to become pregnant or donate sperm/eggs during this period.

Exclusion Criteria

1. The subject was in an acute exacerbation of AD at baseline (e.g., the subject had a tendency to rapidly develop erythroderma or erythroderma in a short period of time, whichever was judged by the investigator);
2. Previous drug therapy with IL-2 or IL-2 analogues (including clinical studies);
3. Use of other immunomodulatory biologics within 3 months prior to baseline or within 5 drug half-lives, whichever is longer, including, but not limited to, anti-IL-23 (e.g., guselkumab), anti-IL-12/23 (e.g., ustekinumab), anti-IL-17 (e.g., secukinumab), or anti-IgE (e.g., omalizumab);
4. Use of cell depleting agents (e.g. rituximab) within 6 months prior to baseline;
5. Use of topical drugs for the treatment of AD or that may affect the assessment of the condition of AD within 2 weeks prior to baseline, including but not limited to TCS, TCI, phosphodiesterase-4 (PDE-4) inhibitors, Janus kinase (JAK) inhibitors, aromatic hydrocarbon receptor agonists, or Chinese herbal or herbal treatments, etc.;
6. ≥ 2 bleaching baths per week within 2 weeks prior to baseline;
7. Systemic treatment (except glucocorticoid inhalers and nasal sprays) with glucocorticoids or other immunosuppressive/immunomodulatory drugs (e.g., cyclosporine, mycophenolate mofetil, azathioprine, methotrexate, or oral JAK inhibitors) within 8 weeks prior to baseline;
8. Use of systemic Chinese herbal medicine within 4 weeks prior to baseline ;
9. Phototherapy (narrow-band ultraviolet B (NBUVB), ultraviolet B (UVB), ultraviolet A (UVA), psoralen + ultraviolet A (PUVA)) tanning beds or any other phototherapy within 4 weeks prior to baseline;
10. Use of any investigational drug/therapy within 3 months or 5 drug half-lives (whichever is longer) prior to baseline;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cohort 1- Low dose group	SIM0278 injection	-
cohort 2-Medium dose group	SIM0278 injection	-
cohort 3-High dose group	SIM0278 injection	-
cohort 4- placebo group	Placebo	-

Primary Outcome Measures

Name	Time	Method
Percent change from baseline in Eczema Area and Severity Index (EASI) score at Week 16 (W16).	At Week 16 (W16)

Trial Locations

Locations (2)

Affiliated Hangzhou First People's Hospital, School of Medicine , West Lake University; 🇨🇳 Hangzhou, China

The First Hospital of China Medical University; 🇨🇳 Shenyang, China