Clinical trial • Phase II • Immunology|Gastroenterology
GUSELKUMAB for Ulcerative colitis
Phase II trial of GUSELKUMAB for Ulcerative colitis.
Overview
- Trial Therapeutic Area
- Immunology|Gastroenterology
- Trial Disease
- Ulcerative colitis
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 15-04-2024
- First CTIS Authorization Date
- 22-05-2024
Trial design
Randomised, guselkumab - solution for injection in pre-filled syringe - 100 mg/ml (comparator); golimumab - solution for injection in pre-filled syringe (comparator); placebo to guselkumab and golimumab and jnj-78934804 (placebo comparator). dose/schedule not specified in ctis metadata except guselkumab product presentation 100 mg/ml.-controlled Phase II trial.
- Randomised
- Yes
- Comparator
- Guselkumab - solution for injection in pre-filled syringe - 100 mg/mL (comparator); Golimumab - solution for injection in pre-filled syringe (comparator); Placebo to Guselkumab and Golimumab and JNJ-78934804 (placebo comparator). Dose/schedule not specified in CTIS metadata except guselkumab product presentation 100 mg/mL.
- Target Sample Size
- 369
Eligibility
Recruits 369 isVulnerablePopulationSelected: false. Study population is adult patients (no minors indicated). Informed consent documents (country-specific ICFs) are provided for adult participants in multiple languages; there is no mention of assent procedures for minors. Pregnant-partner / pregnant-participant ICF addenda are provided in some countries (country-specific documents listed)..
- Pregnancy Exclusion
- If female and of childbearing potential, must meet the contraception and reproduction requirements
- Vulnerable Population
- isVulnerablePopulationSelected: false. Study population is adult patients (no minors indicated). Informed consent documents (country-specific ICFs) are provided for adult participants in multiple languages; there is no mention of assent procedures for minors. Pregnant-partner / pregnant-participant ICF addenda are provided in some countries (country-specific documents listed).
Inclusion criteria
- {"criterion_text":"- Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to baseline\n- Moderately to severely active UC as assessed by the modified mayo score\n- Demonstrated inadequate response, loss of response, or intolerance to at least one advanced therapy (ADT) for IBD that includes biologics as well as oral small molecule therapies with biologic-like effects\n- If female and of childbearing potential, must meet the contraception and reproduction requirements"}
Exclusion criteria
- {"criterion_text":"- Has severe extensive colitis as defined in the protocol\n- Extent of inflammatory disease limited to the rectum\n- Participants with current diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease (CD)\n- Has a history of, or ongoing, chronic or recurrent infectious disease\n- Currently has a malignancy or a history of malignancy within 5 years before screening (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ that has been treated with no evidence of recurrence within 12 months of first dose of study intervention)"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Clinical remission at Week 48 compared with each monotherapy","definition_or_measurement_approach":"Measured as clinical remission at Week 48 (timepoint comparison vs each monotherapy)."}
Recruitment
- Planned Sample Size
- 369
- Recruitment Window Months
- 75
- Consent Approach
- Informed consent is obtained from adult participants. Country-specific subject information and informed consent forms (L1 Country ICF Main) are provided in multiple languages for each country; additional consent addenda are available for genetic research, pregnant partners/participants, and withdrawal. No assent or minor-consent procedures are mentioned in the CTIS metadata.
Sponsor
Primary sponsor
- Full Name
- Janssen - Cilag International
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Contract research organisations
- Name
- Parexel International (IRL) Limited
- Responsibilities
- Various operational sponsor duties listed in CTIS (multiple duty codes present)
- Name
- Excelya Greece CRO Single Member S.A.
- Responsibilities
- Support in submission; other CRO duties as listed in CTIS metadata
- Name
- Almac Clinical Technologies LLC
- Responsibilities
- IVRS / treatment randomisation
Third parties
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central imaging services","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"eCoA","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Canada","full_name":"Alimentiv Inc.","duties_or_roles":"Histopatholoogy image review","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"multiple sponsor duties listed (codes present in CTIS metadata)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Vendor duties (CTIS metadata lists role code 7)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Greece","full_name":"Excelya Greece CRO Single Member S.A.","duties_or_roles":"Support in submission; other duties (codes listed in CTIS metadata)","organisation_type":"Pharmaceutical company (CRO)"}
- {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"IVRS30- treatment randomisation","organisation_type":"Pharmaceutical company"}
- {"country":"Poland","full_name":"Manermed Sp. z o.o.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- Guselkumab - solution for injection in pre-filled syringe - 100 mg/mL
- Active Substance
- GUSELKUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- Subcutaneous use
- Route
- Subcutaneous
- Authorisation Status
- Authorised (product dictionary prodAuthStatus=1)
- Investigational Product Name
- Golimumab
- Active Substance
- GOLIMUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- Subcutaneous use
- Route
- Subcutaneous
- Authorisation Status
- Authorised (product dictionary prodAuthStatus=1)
- Investigational Product Name
- JNJ-78934804
- Active Substance
- GUSELKUMAB, GOLIMUMAB
- Modality
- Monoclonal antibody (combination)
- Routes Of Administration
- Subcutaneous use
- Route
- Subcutaneous
- Authorisation Status
- Authorised (product dictionary prodAuthStatus=1)
- Investigational Product Name
- Placebo to Guselkumab and Golimumab and JNJ-78934804
- Modality
- Other
- Combination Treatment
- Yes
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