What is SCTB35 studying for systemic lupus erythematosus?

SCTB35 is being studied to evaluate its safety, tolerability, and how well it works in patients with systemic lupus erythematosus. Researchers want to find the best dose and understand its effects on disease activity. This trial is sponsored by Sinocelltech Ltd. and aims to gather important information about SCTB35 for people with SLE.

Who may be eligible for this systemic lupus erythematosus clinical trial?

Adults aged 18 to 75 years diagnosed with SLE for at least 12 weeks may be eligible. Participants should have active disease based on specific criteria and be on stable treatment doses. Both males and females can join if they agree to use contraception when needed. Please review eligibility criteria for more details.

Is there any cost to participate in this systemic lupus erythematosus clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional costs they might incur.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years - 75Years

All Genders

ID06841042

Phase IbII Study of SCTB35 Injection for Adults with Systemic Lupus Erythematosus Evaluating Safety and Effectiveness

Led by Sinocelltech Ltd. · Updated on 2025-02-21

168

Participants Needed

Research Sites

74 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating SCTB35 in patients with systemic lupus erythematosus SLE through a multicenter Phase IbII clinical trial. The study aims to assess the safety, tolerability, pharmacokinetics, and preliminary effectiveness of SCTB35 in this patient group. The trial includes both dose-escalation and dose-expansion phases to identify optimal dosing and compare safety and efficacy at recommended dose levels. The study involves administering SCTB35 by subcutaneous injection every 21 days in treatment cycles. During the dose-escalation phase, different dose levels are tested to find the maximum tolerated dose and recommended Phase II dose, with safety data reviewed by a committee. Once the recommended dose is confirmed, expansion cohorts will further evaluate SCTB35 at those doses. Participants will undergo regular assessments including monitoring for adverse events up to 24 weeks, and evaluation of disease activity using measures such as the SLE Responder Index-4, SLEDAI-2K, and physician global assessment. Additional evaluations include immunogenicity and other lupus activity scores up to 52 weeks. The study involves informed consent and contraception requirements, with ongoing safety and efficacy monitoring throughout participation, which lasts up to at least 24 weeks.

CONDITIONS

Brief Title

A Study of SCTB35 in Patients with Systemic Lupus Erythematosus

Who Can Participate

Age: 18Years - 75Years

All Genders

Eligibility Criteria

You may qualify if you...

Age 18 to 75 years
Diagnosed with systemic lupus erythematosus (SLE) for at least 12 weeks prior to screening based on 2019-ACR/EULAR criteria
SLEDAI-2K score of 8 or higher at screening, or 6 or higher if hypocomplementemia or elevated anti-dsDNA antibody levels are present
Positive antinuclear antibody (ANA) at 1:80 or positive anti-dsDNA and/or anti-Sm antibodies within the last 12 months or at screening
Currently receiving at least one stable dose of standard treatment (oral corticosteroids, antimalarials, or immunosuppressive drugs) with stable doses for at least 4 weeks prior to baseline
All male participants or females of reproductive potential must agree to use reliable contraception from signing consent through 6 months after last dose
Understanding and voluntary signing of informed consent form

You will not qualify if you...

Severe active or unstable lupus-related neuropsychiatric disorders
Other autoimmune diseases that may interfere with efficacy evaluation
Catastrophic antiphospholipid syndrome
Receipt of live or attenuated vaccines within 28 days prior to baseline or screening
Clinically significant bleeding risk
Abnormal laboratory results: AST or ALT greater than 2.5 times upper limit of normal, total bilirubin greater than 1.5 times upper limit of normal, ANC less than 1.5 x 10^9/L, platelets less than 75 x 10^9/L, hemoglobin less than 100 g/L
Estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m²
Positive serum HCG
Receipt of any investigational treatment within 30 days prior to baseline or within 5 half-lives of investigational drug
Recurrent, chronic, or other active infections
Severe or uncontrolled disease preventing participation
Positive viral serology including HIV, HCV, and HBV
Known active or latent tuberculosis
Any active infection except nail bed fungal infections
Severe infections
History of progressive multifocal leukoencephalopathy (PML)
Poorly controlled type 1 or type 2 diabetes
Uncontrolled hypertension (systolic >140 mmHg or diastolic >90 mmHg)
History of malignancy within 5 years prior to baseline
Alcohol abuse or drug misuse within 12 months prior to screening
Intolerance or contraindication to study drug including severe allergic reactions
Major surgery requiring hospitalization within 4 weeks prior to screening or within 12 weeks post-study drug
Mental disorders or poor compliance
Severe lupus nephritis
History or expected organ or stem cell transplant during study
Pregnant or breastfeeding
Any other condition deemed unsuitable by investigator

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Phase IbII Study of SCTB35 Injection for Adults with Systemic Lupus Erythematosus Evaluating Safety and Effectiveness

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria