An Open-Label, Single Center Study Evaluating the Safety, Tolerability, and Immunogenicity of Cizutamig for Patients with Moderate to Severe Ulcerative Colitis
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. 18-75 years of age at the time of signing the informed consent form (ICF)
2. Have an established diagnosis of UC
3. Have current evidence of active moderate to severe UC.
4. Have current evidence of UC extending proximal to the rectum
5. Demonstrated intolerance or inadequate response to ≥ 1 biologic and/or other advanced therapies
6. Stable use of any of the following background therapy (alone or in combination) up to Day 1
7. Have documentation of:
1. 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 be if
19\. 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.
