A Study of GB261 in Systemic Sclerosis

An Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Clinical Activity of GB261 in Systemic Sclerosis

Inclusion criteria

• 18 to 75 years old at the time of signing the informed consent form (ICF)
• Diagnosis of SSc according to the 2013 American College of Rheumatology (ACR)/ European Alliance of Associations for Rheumatology (EULAR) classification criteria
• Diffuse cutaneous SSc according to the LeRoy criteria
• Positive for at least 1 SSc-specific parameter as specified in the protocol;
• Disease duration of ≤ 7 years
• mRSS ≥ 15
• Inadequate response to therapies defined in the protocol

Exclusion criteria

• Inadequate clinical laboratory parameters at Screening:
• Receipt of or inability to discontinue any excluded as specified in the protocol:
• Receipt of live vaccine within 4 weeks prior to Screening
• Presence of any concomitant autoimmune disease other than the disease being studied
• Receiving or anticipated to require total parenteral nutrition during the study
• Active or history of intestinal pseudo-obstruction OR small intestinal bacteria overgrowth
• Active or history of gastric antral vascular ectasia
• Active digital ischemia with gangrene OR requiring antibiotics or amputation at Screening or during the study
• Active or history of scleroderma renal crisis
• History of progressive multifocal leukoencephalopathy
• History of primary immunodeficiency or a hereditary deficiency of the complement system
• Central nervous system (CNS) disease
• Have presence of 1 or more significant concurrent medical conditions per investigator judgment
• Have a diagnosis or history of malignant disease within 5 years prior to Screening
• Inability to comply with contraception requirements as specified in the protocol