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

NCT07175233 | Not Yet Recruiting Phase 2

• 1 other identifier: SIM0278-201
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 2

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.

Conditions

Atopic Dermatitis (AD)

Outcome Measures

Primary Outcomes (1)

• Percent change from baseline in Eczema Area and Severity Index (EASI) score at Week 16 (W16).

  At Week 16 (W16)

Study Arms (4)

cohort 1- Low dose group

EXPERIMENTAL

Drug: SIM0278 injection

cohort 2-Medium dose group

EXPERIMENTAL

Drug: SIM0278 injection

cohort 3-High dose group

EXPERIMENTAL

Drug: SIM0278 injection

cohort 4- placebo group

PLACEBO COMPARATOR

Other: Placebo

Interventions

SIM0278 injection DRUG

SIM0278 injection

cohort 1- Low dose group; cohort 2-Medium dose group; cohort 3-High dose group

Placebo OTHER

placebo

cohort 4- placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Atopic dermatitis was diagnosed at screening (according to the American Academy of Dermatology consensus criteria for atopic dermatitis, 2014);
• 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;
• 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.

You may not qualify if:

• 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);
• Previous drug therapy with IL-2 or IL-2 analogues (including clinical studies);
• 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);
• Use of cell depleting agents (e.g. rituximab) within 6 months prior to baseline;
• 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.;
• ≥ 2 bleaching baths per week within 2 weeks prior to baseline;
• 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;
• Use of systemic Chinese herbal medicine within 4 weeks prior to baseline ;
• 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;
• Use of any investigational drug/therapy within 3 months or 5 drug half-lives (whichever is longer) prior to baseline;

Sponsors & Collaborators

• Jiangsu Simcere Pharmaceutical Co., Ltd.: lead

Study Sites (2)

Affiliated Hangzhou First People's Hospital, School of Medicine , West Lake University

Hangzhou, China

Location

The First Hospital of China Medical University

Shenyang, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Yi min Li

CONTACT

+8618021507113; liyimin@simcere.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 16, 2025
• Study Start: October 27, 2025
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): August 20, 2027
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)