Actively Recruiting
A Study of SCTB35 in Patients with Systemic Lupus Erythematosus
Led by Sinocelltech Ltd. · Updated on 2025-02-21
168
Participants Needed
14
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study of SCTB35 in Patients with Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years
- Diagnosed with systemic lupus erythematosus for at least 12 weeks using 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 for ANA (1:80) or positive for anti-dsDNA and/or anti-Sm antibodies within the last 12 months or at screening
- Currently receiving at least one stable dose of oral corticosteroids, antimalarials, or conventional immunosuppressive drugs for at least 4 weeks prior to baseline
- All male participants or females of reproductive potential agree to use reliable contraception from signing informed consent through 6 months after the last dose
- Understanding of study procedures and voluntary signing of informed consent form
You will not qualify if you...
- Severe active or unstable lupus-related neuropsychiatric disorders
- Other autoimmune diseases interfering with efficacy evaluation
- Catastrophic antiphospholipid syndrome
- Received live or attenuated vaccines within 28 days prior to baseline or screening
- Clinically significant bleeding risk
- Abnormal laboratory results including AST or ALT >2.5 x ULN, total bilirubin >1.5 x ULN, ANC <1.5x10^9/L, platelets <75x10^9/L, hemoglobin <100g/L
- eGFR less than 30 mL/min/1.73 m²
- Positive serum HCG
- Received investigational treatment within 30 days prior to baseline or within 5 half-lives of the drug
- Recurrent, chronic, or other active infections
- Severe or uncontrolled disease preventing study participation
- Positive viral serology for HIV, HCV, or 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 or drug abuse within 12 months prior to screening
- Intolerance or contraindications to the study drug
- Hospitalization for major surgery within 4 weeks prior to screening or within 12 weeks post-study drug
- Mental disorders or poor compliance
- Severe lupus nephritis
- History of or expected transplant surgery during study
- Pregnant or breastfeeding
- Other conditions deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, China
Actively Recruiting
2
Xuanwu Hospital, Capital Medical University
Beijing, China
Not Yet Recruiting
3
Jilin Provincial People's Hospital
Changchun, China
Not Yet Recruiting
4
Guangdong Provincial People's Hospital
Guangzhou, China
Not Yet Recruiting
5
Zhejiang Provincial People's Hospital
Hangzhou, China
Not Yet Recruiting
6
The First People's Hospital of Jiujiang City
Jiujiang, China
Not Yet Recruiting
7
The First Affiliated Hospital of Kunming Medical University
Kunming, China
Not Yet Recruiting
8
Linfen Central Hospital
Linfen, China
Not Yet Recruiting
9
Mianyang Central Hospital
Mianyang, China
Not Yet Recruiting
10
The First Affiliated Hospital of Nanchang University
Nanchang, China
Not Yet Recruiting
11
Pingxiang People's Hospital
Pingxiang, China
Not Yet Recruiting
12
Shanxi Bethune Hospital
Taiyuan, China
Not Yet Recruiting
13
The First Affiliated Hospital of Xiamen University
Xiamen, China
Not Yet Recruiting
14
Xinxiang Central Hospital
Xinxiang, China
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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