A Clinical Study to Evaluate SM17 for Atopic Dermatitis

NCT07445919 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: SM17-201
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is a phase 2, randomized, double-Blind, placebo-Controlled, dose-finding clinical study conducted in participants with moderate-to-severe atopic dermatitis. The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics , and pharmacodynamics of SM17 (subcutaneous injection) in participants with moderate to severe atopic dermatitis.

Conditions

Atopic Dermatitis

Keywords

AD; IL-17RB; IL-25 receptor

Outcome Measures

Primary Outcomes (1)

• Efficacy for treating AD - Eczema Area and Severity Index (EASI)

  To evaluate the efficacy of SM17 in adult participants with moderate to severe atopic dermatitis (AD). Percentage change from baseline (CFB, ≥ -100%, with negatively higher percentage indicating a better response, zero or positive percentage indicating no response or worsening ) in Eczema Area and Severity Index (EASI) at Week 16.

  Week 16

Secondary Outcomes (23)

• Efficacy for treating AD - EASI 50%

  Week 12, 16, 24

• Efficacy for treating AD - EASI 75%

  Week 12, 16, 24

• Efficacy for treating AD - EASI 90%

  Week 12, 16, 24

• Efficacy for treating AD - EASI 100%

  Week 12, 16, 24

• Efficacy for treating AD - IGA 0/1%

  Week 12, 16, 24

Other Outcomes (3)

• PD biomarkers - serum total immunoglobulin E (IgE)

  Week 0, 2, 8, 12, 16, 24

• PD biomarkers - peripheral blood eosinophil count(EOS)

  Week 0, 2, 8, 12, 16, 24

• PD biomarkers - serum TARC (CCL-17)

  Week 0, 2, 8, 12, 16, 24

Study Arms (6)

SM17 Group1

EXPERIMENTAL

participants will receive Dose 1 of SM17 with fixed interval 1 from week 0 to week 15, with a loading dose at Week 0

Biological: SM17 for subcutaneous injection; Drug: SM17 placebo for subcutaneous injection

SM17 Group2

EXPERIMENTAL

participants will receive Dose 2 of SM17 with fixed interval 1 from week 0 to week 15，without loading

Biological: SM17 for subcutaneous injection; Drug: SM17 placebo for subcutaneous injection

SM17 Group3

EXPERIMENTAL

participants will receive Dose 3 of SM17 with fixed interval 1 from week 0 to week 15 , with a loading dose at week0

Biological: SM17 for subcutaneous injection; Drug: SM17 placebo for subcutaneous injection

SM17 Group4

EXPERIMENTAL

participants will receive Dose 3 of SM17 with fixed interval 2 from week 0 to week 15, with a loading dose at Week 0

Biological: SM17 for subcutaneous injection

Open labelled Period

EXPERIMENTAL

Start from Week 16 , an open-label treatment period will be applied for all participants upon their discretion. Participants with IGA score 0/1 at week16 will receive Dose 3 of SM17 with Interval 3 until week 20; participants who doesn't reach IGA score 0/1 at week16 will receive Dose 4 of SM17 with Interval 4 until week 20;

Biological: SM17 for subcutaneous injection

Placebo group

PLACEBO COMPARATOR

Matching placebos for experimental arms 1\~4, participants will receive Dose of SM17 placebo with fixed interval 1 or interval 2 (ratio 3:1) from week 0 to week 15 , with a loading dose at Week 0

Drug: SM17 placebo for subcutaneous injection

Interventions

SM17 for subcutaneous injection BIOLOGICAL

SM17 monoclonal antibody for subcutaneous infusion use

Open labelled Period; SM17 Group1; SM17 Group2; SM17 Group3; SM17 Group4

SM17 placebo for subcutaneous injection DRUG

placebo to be compared with SM17, excipient solution of SM17 monoclonal antibody without protein

Placebo group; SM17 Group1; SM17 Group2; SM17 Group3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to sign the informed consent form (ICF), comply with the study procedures, and receive follow-up at the time points required in the protocol.
• Able to understand and complete the study-related questionnaires by themselves or with the assistance of their caregiver/support.
• Male or female, aged 18 to 70 years (inclusive) at the time of signing the ICF.
• Meets the diagnostic criteria for AD (as defined by the Hanifin \& Rajka criteria) during the screening period, and had a history of AD or eczema for at least 1 year before the screening.
• Has an EASI score of ≥16 at screening and baseline.
• Has an Investigator's Global Assessment (IGA) score of ≥3 (on the basis of the 4 point vIGA-AD scale) at screening and baseline.
• A body surface area (BSA) of AD involvement ≥10% at screening and baseline.
• A mean maximum pruritus intensity score of Pruritus Numerical Rating Scale (PP-NRS) ≥4 at baseline.
• Notes: The baseline pruritus NRS score for maximum pruritus intensity will be determined on the basis of the mean of daily NRS scores for maximum pruritus intensity (score range of 0 to 10) within 7 days before randomization. At least 4 daily scores within 7 days before randomization are required to calculate the baseline mean score. For participants who do not report at least 4 daily scores within 7 days before the scheduled randomization date, randomization should be postponed until this requirement is met, but not exceeding the maximum screening period of 28 days.
• Participants with a recent (within 6 months before the screening visit) medical history indicating that they have an inadequate response to topical medications or that the use of topical medications is medically inappropriate (eg, with important side effects or safety risks);
• Notes: Inadequate response is defined as failure to achieve or maintain disease remission or low disease activity (equivalent to IGA score of 0 \[= none\] to 2 \[= mild\]) even on a daily treatment regimen of moderate-to-strong topical corticosteroids (TCSs) (±topical calcineurin inhibitors \[TCIs\], if applicable) for at least 28 days or up to the maximum recommended course of treatment in the product prescription information (eg, 14 days for ultra-strong TCSs), whichever is shorter.
• Important side effects or safety risks are those that, as assessed by the investigator or the participant's attending physician, outweigh the potential benefit of treatment, including treatment intolerance, allergic reactions, significant skin atrophy, and systemic reactions.
• Eligible participants of childbearing potential and their partners must agree to use a medically accepted contraceptive measure (eg, intra-uterine contraceptive device, anticonceptive or condom, or abstinence) during the study and for 6 months after the end of the study, with specific contraceptive measures detailed in the protocol; and have no plans to donate sperm/ova during the study and within 6 months after the end of the study.

You may not qualify if:

• Participants who meet any of the following criteria will not be enrolled in the study:
• Those with general conditions:
• Female participants who are pregnant (pregnancy is defined as the state from conception until the termination of pregnancy), lactating, or have a positive serum human chorionic gonadotropin test result;
• Alcohol abuse (ie, an average weekly consumption of \>14 units of alcohol \[1 unit ≈ 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine\]) and/or drug abuse within half a year before screening;
• Those who experience any of the following in laboratory tests and/or electrocardiogram (ECG) at screening or baseline (if necessary, a repeated test can be conducted for confirmation):
• Hemoglobin \<100.0 g/L (males), or \<90.0 g/L (females);
• White blood cell count \<3.0 × 109/L;
• Neutrophil count \<1.5 × 109/L;
• Platelet count \<100 × 109/L;
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2 × ULN;
• Bilirubin total (T-BIL) \>1.5 × ULN;
• Serum creatinine \>1.5 × ULN;
• A positive hepatitis B surface antigen (HBsAg) test result, a positive hepatitis B core antibody (HbcAb) test result with HBV DNA level above the upper limit of the normal range, or the HIV and anti-hepatitis C virus (HCV) antibody test results are positive with positive HCV RNA, or syphilis infection is present (when the syphilis specific antibody test result is positive, the non-specific antibody test for syphilis shall be added for validation).
• ECG at screening indicates clinically significant abnormalities that may affect the safety of participants, including but not limited to acute myocardial ischemia, myocardial infarction, serious arrhythmia or significant QTcF prolongation (QT interval corrected by Fridericia's formula, QTcF ≥450 ms for males and ≥470 ms for females);
• Those with any of the following medical history or comorbidities:

Sponsors & Collaborators

• SinoMab BioScience Ltd: lead

Study Sites (1)

Peking University People's Hospital

Beijing, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Injections, Subcutaneous

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

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Guolin XU

CONTACT

852-34269833; admin@sinomab.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: February 13, 2026
• First Posted: March 3, 2026
• Study Start: April 5, 2026
• Primary Completion (Estimated): April 25, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

CN (1)