NCT07353450

Brief Summary

A Study of Cizutamig for Patients with Ulcerative Colitis

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at P25-P50 for early_phase_1

Timeline
19mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Jan 2026Dec 2027

First Submitted

Initial submission to the registry

December 26, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 20, 2026

Status Verified

December 1, 2025

Enrollment Period

1.9 years

First QC Date

December 26, 2025

Last Update Submit

January 19, 2026

Conditions

Ulcerative Colitis (UC)

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability

    1. Incidence of treatment-emergent adverse events (TEAEs) through end of study. 2. Severity Grade of treatment-emergent adverse events (TEAEs) through end of study.

    Week 52

Study Arms (1)

A Study of Cizutamig for Patients with Ulcerative Colitis

EXPERIMENTAL

Cizutamig intravenous intervention

Biological: cizutamig

Interventions

cizutamigBIOLOGICAL

Cizutamig will be dosed according to the protocol

A Study of Cizutamig for Patients with Ulcerative Colitis

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age at the time of signing the informed consent form (ICF)
  • Have an established diagnosis of UC
  • Have current evidence of active moderate to severe UC.
  • Have current evidence of UC extending proximal to the rectum
  • Demonstrated intolerance or inadequate response to ≥ 1 biologic and/or other advanced therapies
  • Stable use of any of the following background therapy (alone or in combination) up to Day 1
  • Have documentation of:
  • A surveillance colonoscopy (performed according to local standards) within 12 months of or during Screening, for patients with pancolitis of \> 8 years duration, left-sided colitis of \> 12 years duration, or primary sclerosing cholangitis; OR

You may not qualify if:

  • \. History of splenectomy, including patients with functional asplenia 20. Any serious medical condition or abnormality on clinical laboratory testing 21. Inability to comply with contraception requirements as specified in the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Central Study Contacts

Duo wu Zou

CONTACT

13901617608zdw_pi@126.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2025

First Posted

January 20, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

January 20, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)