A Study of Cizutamig in Systemic Sclerosis

September 4, 2025 updated by: Ruijin Hospital

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

The purpose of this study is to assess the safety, tolerability, PK, PD, immunogenicity, and preliminary clinical activity of cizutamig in patients with SSc.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

ICriteria: 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 therapies 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A study of cizutamig in patients with Systemic Sclerosis (Ssc)
Drug: Biological: cizutamig
Cizutamig will be dosed according to the protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of treatment-emergent adverse events (TEAEs) through end of study
Time Frame: 52weeks
52weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 4, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

August 25, 2025

First Submitted That Met QC Criteria

September 4, 2025

First Posted (Estimated)

September 8, 2025

Study Record Updates

Last Update Posted (Estimated)

September 8, 2025

Last Update Submitted That Met QC Criteria

September 4, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CND106-RUJN -1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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