A Study of Cizutamig in Systemic Sclerosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biological: cizutamig.
- Who it may be relevant to
- Registry conditions: Systemic Sclerosis (SSc). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Clinical Activity of Cizutamig in Systemic Sclerosis
Overview
The purpose of this study is to assess the safety, tolerability, PK, PD, immunogenicity, and preliminary clinical activity of cizutamig in patients with SSc.
Detailed description
An Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Clinical Activity of Cizutamig in Systemic Sclerosis
Interventions
- Drug Biological: cizutamig
Cizutamig will be dosed according to the protocol.
Primary outcome measures
- Incidence and severity of treatment-emergent adverse events (TEAEs) through end of study [Time frame: 52weeks]
Eligibility criteria
ICriteria: 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 therapies 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07158996 · CND106-RUJN -1