Atopic DermatitisPhase 2NCT07445919
A Clinical Study to Evaluate SM17 for Atopic Dermatitis
A Phase 2 study testing SM17 for subcutaneous injection in people with Atopic Dermatitis, run by SinoMab BioScience Ltd at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- SM17 for subcutaneous injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2026to 30 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet all of the following inclusion criteria to be eligible for study participation:
- 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.
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- 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.
- Those who use topical mild emollients (moisturizers) at least twice daily for at least 7 consecutive days before randomization. For restrictions on the types of emollients not allowed during the study, see exclusion criterion 5.
- 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.
Who cannot join
- 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);
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- 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:
- History of vernal keratoconjunctivitis (VKC) and/or atopic keratoconjunctivitis (AKC); or active dermatosis that may confound the diagnosis of AD or interfere with the evaluation of treatment (eg, psoriasis, body tinea, cutaneous lupus erythematosus), generalized pigmentation or extensive scarring, or other types of eczema (allergic contact dermatitis);
- Known or suspected history of immunosuppressive diseases, including history of invasive opportunistic infections (eg, tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, or aspergillosis), although having been relieved; or abnormally frequent, recurrent or long-term infections as judged by the investigator;
- Participants with chronic active or acute infections requiring systemic treatment with antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before screening or from screening to baseline;
- Those with current evidence of active tuberculosis (TB) or occult TB infections (abnormal chest CT results determined by research show the presence of active TB, and suspected latent or old TB lesions can be confirmed by QuantiFERON Gold test at the discretion of the investigator);
- Those definitively diagnosed with lymphoma, leukemia, or any malignant tumor within 5 years before screening (except squamous cell carcinoma of skin, basal cell carcinoma, or carcinoma cervix in situ that is completely resected without evidence of recurrence);
- Previous or current significant medical diseases that will interfere with the study process and/or evaluation, as considered by the investigator, including but not limited to cardio-cerebrovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, nervous system and psychiatric diseases, as well as other conditions that are inappropriate for participation in the study, as judged by the investigator;
- The participant has a history of allergy to SM17 or its components, or a history of immediate allergy to other drugs (as defined by Sampson criteria), a history of allergy to monoclonal antibodies and their components, clinically significant multiple or severe drug allergies, or severe post-treatment hypersensitivity (including but not limited to severe erythema multiforme, toxic epidermal necrolysis or Stevens-Johnson syndrome, and dermatitis exfoliative); Notes: Sampson criteria: 1.) Acute onset of an illness with involvement of the skin, mucosal tissue or both, and at least one of respiratory compromises, reduced blood pressure (BP) or associated symptoms of end-organ dysfunction; 2.) Any 2 or more of the above symptoms that occur rapidly after exposure to a likely allergen for that patient; 3.) Reduced BP after exposure to known allergen for that participant.
- Those who use any of the following medications/treatments and are not expected to withdraw/discontinue such treatment(s) throughout the study:
- Systemic application of corticosteroids, immunosuppressants, Janus kinase inhibitors for AD within 4 weeks before baseline;
- Antihistamines or inhaled corticosteroids within 1 week before baseline (those who have been treated with antihistamines or inhaled corticosteroids at a stable dose for at least 7 days before baseline and are scheduled to continue to use them during the study may be enrolled);
- Systemic herbal therapy for AD within 4 weeks before baseline;
- Ultraviolet therapies for AD (including but not limited to narrow-band ultraviolet B [NB-UVB] or medium-to high-dose UVA1) or regular use of artificial sunbathing for AD within 4 weeks before baseline;
- ≥2 bleach baths within 2 weeks before baseline;
- The following topical medications for the treatment of AD within 1 week before baseline: a) Topical corticosteroids or topical calcineurin inhibitors; b) Other alternative therapy including topical traditional Chinese medicines; c) Other topical medications (including but not limited to topical phosphodiesterase-4 [PDE-4] inhibitors);
- Those who have received biologics for AD before baseline: a) Any cell scavenger and/or cell depleting agent, including but not limited to rituximab; b) Other biologics: within 5 half-lives (if known) or 16 weeks before baseline, whichever is longer;
- Those who have received allergen-specific immunotherapies within 6 months before baseline;
- Those who have used prescription emollients or emollients containing active ingredients (eg, ceramides, hyaluronic acid, urea, or filaggrin degradation products) within 1 week before baseline;
- Those who have undergone major surgery within 3 months before baseline or who have not yet recovered after the surgery, or who plan to undergo major surgery during the study;
- Those who have a history of blood donation or severe blood loss (total blood volume ≥500 mL) within 1 month before screening, or have received transfusion within 2 months before screening; or who have donated bone marrow stem cells within 3 months before screening;
- Those who have received an attenuate live vaccine within 3 months before baseline, or plan to receive an attenuated live vaccine during the study;
- Those who have participated in other interventional clinical studies (have signed an ICF and received active drug/device treatment) within 6 months before baseline;
- Those who have participated in an anti-IL-25 antibody, or anti-IL-17RB antibody (including SM17) clinical study; Those who have had other conditions within 12 months before screening that, in the opinion of the investigator, may pose a risk to the participants' participation in this study or may interfere with study procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing
Jianzhong Zhang, Dr.
Cheng Zhou
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Clinical Study to Evaluate the Efficacy and Safety of SM17 Monoclonal Antibody Injection (Subcutaneous Injection) in Participants With Moderate to Severe Atopic Dermatitis
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.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, parallel-group, dose-finding Phase 2 clinical study of participants with moderate to severe AD to evaluate the efficacy, safety, PK, PD, and immunogenicity of SM17 after multiple SC doses with different dosage regimens. This study will also explore the optimal dosage regimen to provide the basis for dose selection in subsequent clinical studies.
Patients with moderate to severe AD who have an inadequate response to or are intolerant to topical corticosteroids and/or topical calcineurin inhibitors will be enrolled if eligible. The study includes a 4-week screening period, a 16-week double-blind treatment period, a 4-week open-label treatment period, and a safety follow-up period (4 weeks after the last dose).
During the 16-week double-blind treatment period, 200 participants with moderate to severe AD are planned to be enrolled and randomized into 1 of 4 cohorts receiving either SM17 SC or placebo SC.
Participants in each cohort will continue dosing according to the prescribed dosage regimen until Week 14 (until Week 15 for Cohort 4 [QW dosage group]) and will undergo a visit at the end of the double-blind treatment period at Week 16 (Day 113). From Week 16 (Day 113), enrollment to the 4-week open-label treatment period will be at the participant's discretion. Participants who opt to enter the open-label treatment period will be assigned to 1 of 2 cohorts depending on their IGA Score at Week 16.
A safety follow-up will be conducted 4 weeks after the last dose (Week 24). If a participant does not enter the open-label treatment period, safety follow-up will be conducted at 4 weeks after the last dose, and the participant's participation will conclude.
During the study, participants will undergo AD-related clinical efficacy assessments (including investigator assessment and patient-reported scales), safety and tolerability assessments (including laboratory tests), PK, and immunogenicity (ADA) sample collection, and sample collection related to biomarker detection within defined visit windows.
- Conditions
- Atopic Dermatitis
- Being tested
- SM17 for subcutaneous injection, SM17 placebo for subcutaneous injection
- Keywords
- AD, IL-17RB, IL-25 receptor
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SM17 for subcutaneous injectionBiological
SM17 monoclonal antibody for subcutaneous infusion use
SM17 placebo for subcutaneous injectionDrug
placebo to be compared with SM17, excipient solution of SM17 monoclonal antibody without protein
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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; Receives: 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 Receives: Drug: SM17 placebo for subcutaneous injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 16
Secondary outcomes (23)
Efficacy for treating AD - EASI 50%
To further evaluate the efficacy of SM17 in adult participants with moderate to severe AD.
Proportion of participants achieving EASI-50 (≥50% improvement from baseline in EASI) at Weeks 12, 16, and 24
Measured: Week 12, 16, 24
Efficacy for treating AD - EASI 75%
To further evaluate the efficacy of SM17 in adult participants with moderate to severe AD.
Proportion of participants achieving EASI-75 (≥75% improvement from baseline in EASI) at Weeks 12, 16, and 24
Measured: Week 12, 16, 24
Efficacy for treating AD - EASI 90%
To further evaluate the efficacy of SM17 in adult participants with moderate to severe AD.
Proportion of participants achieving EASI-90 (≥90% improvement from baseline in EASI) at Weeks 12, 16, and 24
Measured: Week 12, 16, 24
Efficacy for treating AD - EASI 100%
To further evaluate the efficacy of SM17 in adult participants with moderate to severe AD.
Proportion of participants achieving EASI-100 (100% improvement from baseline in EASI) at Weeks 12, 16, and 24.
Measured: Week 12, 16, 24
Efficacy for treating AD - IGA 0/1%
To further evaluate the efficacy of SM17 in adult participants with moderate to severe AD.
Proportion of participants achieving Investigator's Global Assessment (IGA) of 0/1 (a validated IGA for AD [vIGA-AD] of 0 or 1 and a decrease of at least 2 points from baseline) at Weeks 12, 16, and 24.
Measured: Week 12, 16, 24
Efficacy for treating AD - PP-NRS
To further evaluate the efficacy of SM17 in adult participants with moderate to severe AD.
Proportion of participants achieving a ≥4-point improvement in the Numeric Rating Scale (NRS-4; a decrease of at least 4 points from baseline in weekly average Peak Pruritus-Numeric Rating Scale [PP-NRS] before the visit) at Weeks 12, 16, and 24
Measured: Week 12, 16, 24
Efficacy for treating AD-EASI score change
To further evaluate the efficacy of SM17 in adult participants with moderate to severe AD.
Changes and percentage CFBs(0~100%) in EASI at Weeks 2, 4, 6, 8, 10, 12, 14, 20, and 24.
Measured: Week 2, 4, 6, 8, 10, 12, 14, 20, 24
Efficacy for treating AD- vIGA-AD change
To further evaluate the efficacy of SM17 in adult participants with moderate to severe AD.
Changes and percentage CFBs(0~100%) in vIGA-AD at Weeks 2, 4, 6, 8, 10, 12, 14, 16, 20, and 24.
Measured: Week 2, 4, 6, 8, 10, 12, 14, 16, 20, 24
Efficacy for treating AD - PP-NRS biweekly change
To further evaluate the efficacy of SM17 in adult participants with moderate to severe AD.
Changes and percentage CFBs(0~100%) in weekly average of daily PP-NRS at Weeks 2, 4, 6, 8, 10, 12, 14, 16, 20, and 24 (calculated on the basis of 7 consecutive days before the visit)
Measured: Week 2, 4, 6, 8, 10, 12, 14, 16, 20, 24
Efficacy for treating AD - PP-NRS weekly change
To further evaluate the efficacy of SM17 in adult participants with moderate to severe AD.
Changes and percentage CFBs(0~100%) in weekly average of daily PP-NRS from Weeks 1 to 16 (calculated on the basis of 7 consecutive days per calendar week)
Measured: Week 1 to 16
Efficacy for treating AD - BSA change
To further evaluate the efficacy of SM17 in adult participants with moderate to severe AD.
Changes and percentage CFBs(0~100%) in affected body surface area (BSA) at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24
Measured: Week 2, 4, 6, 8, 10, 12, 16, 20, 24
Efficacy for treating AD - SCORAD change
To further evaluate the efficacy of SM17 in adult participants with moderate to severe AD.
Changes and percentage CFBs(0~100%) in Scoring Atopic Dermatitis (SCORAD) at each visit at Weeks 4, 8, 12, 16, 20, and 24
Measured: Week 4, 8, 12, 16, 20, 24
Efficacy for treating AD - POEM
To further evaluate the efficacy of SM17 in adult participants with moderate to severe AD.
Changes and percentage CFBs(0~100%) in Patient Oriented Eczema Measure (POEM) at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24
Measured: Week 2, 4, 6, 8, 10, 12, 16, 20, 24
Efficacy for treating AD - DLQI
To further evaluate the efficacy of SM17 in adult participants with moderate to severe AD.
Changes and percentage CFBs(0~100%) in Dermatology Life Quality Index (DLQI) at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24
Measured: Week 2, 4, 6, 8, 10, 12, 16, 20, 24
Incidence of treatment emergent AEs and SAEs
To evaluate the safety and tolerability of multiple doses of SM17 in adult participants with moderate to severe AD.
Incidences of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) occurring during the period following the first dose to the end of the study.
CFB in clinical laboratory assessments, vital signs, physical examination, and electrocardiogram during the period following the first dose to the end of the study.
Measured: Day0 to Day169
Area under the plasma concentration versus time curve (AUC)
To evaluate the PK parameter(AUC), which calculated from serum SM17 concentration, of multiple doses of SM17 in adult participants with moderate to severe AD.
If applicable, the relationship of drug concentrations or PK parameters with efficacy and safety will be explored
Measured: Week 0, 1, 2, 4, 8, 12, 14, 15, 16, 20, 24
Peak Plasma Concentration (Cmax)
To evaluate the PK parameter(Cmax), which calculated from serum SM17 concentration, of multiple doses of SM17 in adult participants with moderate to severe AD.
If applicable, the relationship of drug concentrations or PK parameters with efficacy and safety will be explored
Measured: Week 0, 1, 2, 4, 8, 12, 14, 15, 16, 20, 24
Time to peak (Tmax)
To evaluate the PK parameter(Tmax), which calculated from serum SM17 concentration, of multiple doses of SM17 in adult participants with moderate to severe AD.
If applicable, the relationship of drug concentrations or PK parameters with efficacy and safety will be explored
Measured: Week 0, 1, 2, 4, 8, 12, 14, 15, 16, 20, 24
Elimination half-life (T1/2)
To evaluate the PK parameter(T 1/2), which calculated from serum SM17 concentration, of multiple doses of SM17 in adult participants with moderate to severe AD.
If applicable, the relationship of drug concentrations or PK parameters with efficacy and safety will be explored
Measured: Week 0, 1, 2, 4, 8, 12, 14, 15, 16, 20, 24
Elimination Rate Constant (Kel)
To evaluate the PK parameter(Kel), which calculated from serum SM17 concentration, of multiple doses of SM17 in adult participants with moderate to severe AD.
If applicable, the relationship of drug concentrations or PK parameters with efficacy and safety will be explored
Measured: Week 0, 1, 2, 4, 8, 12, 14, 15, 16, 20, 24
Total drug clearance from plasma (CL)
To evaluate the PK parameter(CL), which calculated from serum SM17 concentration, of multiple doses of SM17 in adult participants with moderate to severe AD.
If applicable, the relationship of drug concentrations or PK parameters with efficacy and safety will be explored
Measured: Week 0, 1, 2, 4, 8, 12, 14, 15, 16, 20, 24
Apparent volume of distribution at steady state after extravascular administration (Vz)
To evaluate the PK parameter(Vz), which calculated from serum SM17 concentration, of multiple doses of SM17 in adult participants with moderate to severe AD.
If applicable, the relationship of drug concentrations or PK parameters with efficacy and safety will be explored
Measured: Week 0, 1, 2, 4, 8, 12, 14, 15, 16, 20, 24
Immunogenicity
To evaluate the immunogenicity of SM17 in adult participants with moderate to severe AD.
Incidence of treatment emergent anti-drug antibodies (ADAs) during the study
Measured: Week 0, 4, 8, 12, 16, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start31 Mar 2026
- Primary completion25 Apr 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SinoMab BioScience Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445919
- Sponsor's protocol ID
- SM17-201
- Status last verified
- Mar 2026
- First submitted
- 13 Feb 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Clinical Study to Evaluate the Efficacy and Safety of SM17 Monoclonal Antibody Injection (Subcutaneous Injection) in Participants With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT07445919
- Acronym / sponsor ID
- SM17-201
- Conditions
- Atopic Dermatitis
- Keywords
- AD, IL-17RB, IL-25 receptor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- SinoMab BioScience LtdIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- 25 Apr 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a randomized, double-blind, placebo-controlled, parallel-group, dose-finding Phase 2 clinical study of participants with moderate to severe AD to evaluate the efficacy, safety, PK, PD, and immunogenicity of SM17 after multiple SC doses with different dosage regimens. This study will also explore the optimal dosage regimen to provide the basis for dose selection in subsequent clinical studies.
Patients with moderate to severe AD who have an inadequate response to or are intolerant to topical corticosteroids and/or topical calcineurin inhibitors will be enrolled if eligible. The study includes a 4-week screening period, a 16-week double-blind treatment period, a 4-week open-label treatment period, and a safety follow-up period (4 weeks after the last dose).
During the 16-week double-blind treatment period, 200 participants with moderate to severe AD are planned to be enrolled and randomized into 1 of 4 cohorts receiving either SM17 SC or placebo SC.
Participants in each cohort will continue dosing according to the prescribed dosage regimen until Week 14 (until Week 15 for Cohort 4 [QW dosage group]) and will undergo a visit at the end of the double-blind treatment period at Week 16 (Day 113). From Week 16 (Day 113), enrollment to the 4-week open-label treatment period will be at the participant's discretion. Participants who opt to enter the open-label treatment period will be assigned to 1 of 2 cohorts depending on their IGA Score at Week 16.
A safety follow-up will be conducted 4 weeks after the last dose (Week 24). If a participant does not enter the open-label treatment period, safety follow-up will be conducted at 4 weeks after the last dose, and the participant's participation will conclude.
During the study, participants will undergo AD-related clinical efficacy assessments (including investigator assessment and patient-reported scales), safety and tolerability assessments (including laboratory tests), PK, and immunogenicity (ADA) sample collection, and sample collection related to biomarker detection within defined visit windows.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| SM17 Group1 | Experimental | Biological: SM17 for subcutaneous injection, Drug: SM17 placebo for subcutaneous injectionparticipants will receive Dose 1 of SM17 with fixed interval 1 from week 0 to week 15, with a loading dose at Week 0 |
| SM17 Group2 | Experimental | Biological: SM17 for subcutaneous injection, Drug: SM17 placebo for subcutaneous injectionparticipants will receive Dose 2 of SM17 with fixed interval 1 from week 0 to week 15，without loading |
| SM17 Group3 | Experimental | Biological: SM17 for subcutaneous injection, Drug: SM17 placebo for subcutaneous injectionparticipants will receive Dose 3 of SM17 with fixed interval 1 from week 0 to week 15 , with a loading dose at week0 |
| SM17 Group4 | Experimental | Biological: SM17 for subcutaneous injectionparticipants will receive Dose 3 of SM17 with fixed interval 2 from week 0 to week 15, with a loading dose at Week 0 |
| Open labelled Period | Experimental | Biological: SM17 for subcutaneous injectionStart 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; |
| Placebo group | Placebo comparator | Drug: SM17 placebo for subcutaneous injectionMatching 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Participants must meet all of the following inclusion criteria to be eligible for study participation:
- 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.
Key exclusion criteria (37 listed)
- Those with general conditions:
- 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):
- Those with any of the following medical history or comorbidities:
- Those who use any of the following medications/treatments and are not expected to withdraw/discontinue such treatment(s) throughout the study:
- Those who have used prescription emollients or emollients containing active ingredients (eg, ceramides, hyaluronic acid, urea, or filaggrin degradation products) within 1 week before baseline;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SM17 for subcutaneous injectionSM17 monoclonal antibody for subcutaneous infusion use | Biological | Open labelled Period, SM17 Group1, SM17 Group2, SM17 Group3, SM17 Group4 |
| SM17 placebo for subcutaneous injectionplacebo to be compared with SM17, excipient solution of SM17 monoclonal antibody without protein | Drug | Placebo group, SM17 Group1, SM17 Group2, SM17 Group3 |
Primary outcome
Efficacy for treating AD - Eczema Area and Severity Index (EASI)
Time frame: Week 16
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.
23 secondary outcomes
Efficacy for treating AD - EASI 50%
Time frame: Week 12, 16, 24
Efficacy for treating AD - EASI 75%
Time frame: Week 12, 16, 24
Efficacy for treating AD - EASI 90%
Time frame: Week 12, 16, 24
Efficacy for treating AD - EASI 100%
Time frame: Week 12, 16, 24
Efficacy for treating AD - IGA 0/1%
Time frame: Week 12, 16, 24
Efficacy for treating AD - PP-NRS
Time frame: Week 12, 16, 24
Efficacy for treating AD-EASI score change
Time frame: Week 2, 4, 6, 8, 10, 12, 14, 20, 24
Efficacy for treating AD- vIGA-AD change
Time frame: Week 2, 4, 6, 8, 10, 12, 14, 16, 20, 24
Efficacy for treating AD - PP-NRS biweekly change
Time frame: Week 2, 4, 6, 8, 10, 12, 14, 16, 20, 24
Efficacy for treating AD - PP-NRS weekly change
Time frame: Week 1 to 16
Efficacy for treating AD - BSA change
Time frame: Week 2, 4, 6, 8, 10, 12, 16, 20, 24
Efficacy for treating AD - SCORAD change
Time frame: Week 4, 8, 12, 16, 20, 24
Efficacy for treating AD - POEM
Time frame: Week 2, 4, 6, 8, 10, 12, 16, 20, 24
Efficacy for treating AD - DLQI
Time frame: Week 2, 4, 6, 8, 10, 12, 16, 20, 24
Incidence of treatment emergent AEs and SAEs
Time frame: Day0 to Day169
Area under the plasma concentration versus time curve (AUC)
Time frame: Week 0, 1, 2, 4, 8, 12, 14, 15, 16, 20, 24
Peak Plasma Concentration (Cmax)
Time frame: Week 0, 1, 2, 4, 8, 12, 14, 15, 16, 20, 24
Time to peak (Tmax)
Time frame: Week 0, 1, 2, 4, 8, 12, 14, 15, 16, 20, 24
Elimination half-life (T1/2)
Time frame: Week 0, 1, 2, 4, 8, 12, 14, 15, 16, 20, 24
Elimination Rate Constant (Kel)
Time frame: Week 0, 1, 2, 4, 8, 12, 14, 15, 16, 20, 24
Total drug clearance from plasma (CL)
Time frame: Week 0, 1, 2, 4, 8, 12, 14, 15, 16, 20, 24
Apparent volume of distribution at steady state after extravascular administration (Vz)
Time frame: Week 0, 1, 2, 4, 8, 12, 14, 15, 16, 20, 24
Immunogenicity
Time frame: Week 0, 4, 8, 12, 16, 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SM17 for subcutaneous injection in people with Atopic Dermatitis, run by SinoMab BioScience Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guolin XU (852-34269833, admin@sinomab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy for treating AD - Eczema Area and Severity Index (EASI) (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.