Systemic Sclerosis (SSc)
Conditions
Brief summary
The purpose of this study is to assess the safety, tolerability, PK, PD, immunogenicity, and preliminary clinical activity of GB261 in patients with SSc.
Detailed description
An Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Clinical Activity of GB261 in Systemic Sclerosis
Interventions
DRUGBiological: GB261
GB261 will be dosed according to the protocol
Sponsors
Ruijin Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 18 to 75 years old at the time of signing the informed consent form (ICF) 2. Diagnosis of SSc according to the 2013 American College of Rheumatology (ACR)/ European Alliance of Associations for Rheumatology (EULAR) classification criteria 3. Diffuse cutaneous SSc according to the LeRoy criteria 4. Positive for at least 1 SSc-specific parameter as specified in the protocol; 5. Disease duration of ≤ 7 years 6. mRSS ≥ 15 7. Inadequate response to therapies defined in the protocol
Exclusion criteria
1. Inadequate clinical laboratory parameters at Screening: 2. Receipt of or inability to discontinue any excluded as specified in the protocol: 3. Receipt of live vaccine within 4 weeks prior to Screening 4. Presence of any concomitant autoimmune disease other than the disease being studied 5. Receiving or anticipated to require total parenteral nutrition during the study 6. Active or history of intestinal pseudo-obstruction OR small intestinal bacteria overgrowth 7. Active or history of gastric antral vascular ectasia 8. Active digital ischemia with gangrene OR requiring antibiotics or amputation at Screening or during the study 9. Active or history of scleroderma renal crisis 10. History of progressive multifocal leukoencephalopathy 11. History of primary immunodeficiency or a hereditary deficiency of the complement system 12. Central nervous system (CNS) disease 13. Have presence of 1 or more significant concurrent medical conditions per investigator judgment 14. Have a diagnosis or history of malignant disease within 5 years prior to Screening 15. Inability to comply with contraception requirements as specified in the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of treatment-emergent adverse events (TEAEs) through end of study | 52weeks |
Contacts
Primary ContactChengde Yang
Backup ContactQiongyi Hu
Outcome results
None listed