A Study of SCTB35 in Patients with Systemic Lupus Erythematosus
A Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SCTB35 in Patients with Systemic Lupus Erythematosus
1 other identifier
interventional
168
1 country
14
Brief Summary
This study is a multicenter Phase Ib/II clinical trial aimed at evaluating the safety, tolerability and efficacy of SCTB35 in patients with systemic lupus erythematosus (SLE).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2025
Typical duration for phase_1
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2025
CompletedFirst Submitted
Initial submission to the registry
February 11, 2025
CompletedFirst Posted
Study publicly available on registry
February 21, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2028
February 21, 2025
February 1, 2025
2.2 years
February 11, 2025
February 18, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Dose-escalation part： Incidence rate of adverse event (AE)
To evaluate the incidence rates of treatment emergent adverse event (TEAE), treatment-related TEAE (TRAE), serious adverse event (SAE), adverse event with special interest (AESI)
From first dose to the 24 weeks
Dose-expansion part：SRI-4
Percentage of subjects who achieved an SRI-4 response at 24 weeks；
Up to Week 24
Secondary Outcomes (7)
Dose-escalation part： SLEDAI-2K
Up to week 12, 24
Dose-escalation part： physician global assessment (PGA)
Up to week 12, 24
Dose-escalation part：Immunogenicity；
From baseline to Week 24
Dose-expansion part：SLEDAI-2K
Up to week 12, 24
Dose-expansion part： BILAG
Up to week 12, 24
- +2 more secondary outcomes
Study Arms (1)
Experimental: SCTB35
EXPERIMENTALSCTB35 will be administered every 21 days per treatment cycle.
Interventions
SCTB35 will be subcutaneously administered at a dose as specified in the respective dose-escalation cohorts. Then, the RP2D and other appropriate doses of SCTB35 will be applied for the dose-expansion cohorts.
Eligibility Criteria
You may qualify if:
- Age 18-75 years；
- Diagnosed with SLE for ≥12 weeks prior to screening (2019-ACR/EULAR criteria);
- SLEDAI-2K ≥ 8 at screening, or ≥6 if there is hypocomplementemia or elevated anti-dsDNA antibody levels;
- Positive for ANA (1:80) or positive for anti-dsDNA and/or anti-Sm antibodies within the last 12 months or at screening;
- Currently receiving ≥1 stable dose of standard treatment: oral corticosteroids, antimalarials, or conventional immunosuppressive drugs
- Stable corticosteroid dose for ≥4 weeks prior to baseline;
- Stable dose of antimalarial drugs for ≥4 weeks prior to baseline;
- Stable dose of immunosuppressive agents for ≥4 weeks prior to baseline;
- All male participants or females of reproductive potential must agree to use reliable contraception with their partner from signing the ICF through 6 months after the last dose of the study drug;
- Understanding of the study procedures and voluntary signing of the informed consent form.
You may not qualify if:
- Severe active or unstable lupus-related neuropsychiatric disorders;
- Other autoimmune diseases that may interfere with efficacy evaluation;
- Catastrophic antiphospholipid syndrome;
- Received treatments that may affect the drug's effect:
- Received live vaccines or attenuated vaccines within 28 days prior to baseline or screening;
- Clinically significant bleeding risk;
- Abnormal laboratory results:
- AST or ALT \>2.5 x ULN;
- Total bilirubin \>1.5 x ULN;
- ANC \<1.5x10⁹/L;
- Platelets \<75x10⁹/L;
- Hemoglobin \<100g/L;
- eGFR \<30 mL/min/1.73 m²;
- Positive serum HCG;
- Received any investigational treatment within 30 days prior to baseline or within 5 half-lives of the investigational drug (whichever is longer);
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, China
Xuanwu Hospital, Capital Medical University
Beijing, China
Jilin Provincial People's Hospital
Changchun, China
Guangdong Provincial People's Hospital
Guangzhou, China
Zhejiang Provincial People's Hospital
Hangzhou, China
The First People's Hospital of Jiujiang City
Jiujiang, China
The First Affiliated Hospital of Kunming Medical University
Kunming, China
Linfen Central Hospital
Linfen, China
Mianyang Central Hospital
Mianyang, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
Pingxiang People's Hospital
Pingxiang, China
Shanxi Bethune Hospital
Taiyuan, China
The First Affiliated Hospital of Xiamen University
Xiamen, China
Xinxiang Central Hospital
Xinxiang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2025
First Posted
February 21, 2025
Study Start
February 1, 2025
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
October 1, 2028
Last Updated
February 21, 2025
Record last verified: 2025-02