Trial record 1 of 33 for:
VEGA ulcerative colitis
A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis (VEGA)
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| ClinicalTrials.gov Identifier: NCT03662542 |
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Recruitment Status :
Completed
First Posted : September 7, 2018
Last Update Posted : January 3, 2022
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Sponsor:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Janssen Research & Development, LLC
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Brief Summary:
The purpose of this study is to evaluate the clinical efficacy and safety of combination therapy with guselkumab and golimumab in participants with moderately to severely active ulcerative colitis (UC).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Colitis, Ulcerative | Drug: Guselkumab Dose 1 Drug: Guselkumab Dose 2 Drug: Golimumab Dose 1 Drug: Golimumab Dose 2 Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 214 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2a Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter, Proof-of-concept Clinical Study to Evaluate the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis |
| Actual Study Start Date : | November 20, 2018 |
| Actual Primary Completion Date : | December 1, 2020 |
| Actual Study Completion Date : | November 15, 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Ulcerative colitis
MedlinePlus related topics:
Ulcerative Colitis
| Arm | Intervention/treatment |
|---|---|
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Experimental: Combination Therapy
Participants will receive guselkumab Dose 1 as intravenous (IV) infusion and Dose 2 as subcutaneous (SC) injection; and golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind.
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Drug: Guselkumab Dose 1
Guselkumab Dose 1 will be administered as IV infusion. Drug: Guselkumab Dose 2 Guselkumab Dose 2 will be administered as SC injection. Drug: Golimumab Dose 1 Golimumab Dose 1 will be administered as SC injection. Drug: Golimumab Dose 2 Golimumab Dose 2 will be administered as SC injection. Drug: Placebo Placebo will be administered. |
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Experimental: Monotherapy: Guselkumab
Participants will receive guselkumab Dose 1 as IV infusion, Dose 2 as SC injection and placebo to maintain the blind.
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Drug: Guselkumab Dose 1
Guselkumab Dose 1 will be administered as IV infusion. Drug: Guselkumab Dose 2 Guselkumab Dose 2 will be administered as SC injection. Drug: Placebo Placebo will be administered. |
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Active Comparator: Monotherapy: Golimumab
Participants will receive golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind.
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Drug: Golimumab Dose 1
Golimumab Dose 1 will be administered as SC injection. Drug: Golimumab Dose 2 Golimumab Dose 2 will be administered as SC injection. Drug: Placebo Placebo will be administered. |
Primary Outcome Measures :
- Clinical Response at Week 12 [ Time Frame: Week 12 ]Clinical response as defined by Mayo score. The Mayo score is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, physician's global assessment, and endoscopy findings - each with score range of 0 (normal activity) to 3 (severe activity) and a total score range of 0 to 12 points. A score of 3 to 5 points indicates mildly active disease, a score of 6 to 10 points indicates moderately active disease, and a score of 11 to 12 points indicates severely active disease.
Secondary Outcome Measures :
- Clinical Remission at Week 12 [ Time Frame: Week 12 ]Clinical remission as defined by Mayo score. The Mayo score is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, physician's global assessment, and endoscopy findings - each with score range of 0 (normal activity) to 3 (severe activity) and a total score range of 0 to 12 points. A score of 3 to 5 points indicates mildly active disease, a score of 6 to 10 points indicates moderately active disease, and a score of 11 to 12 points indicates severely active disease.
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Confirmed clinical diagnosis of ulcerative colitis (UC) at least 3 months before screening
- Moderately to severely active UC as defined by Mayo score
- History of inadequate response to or failure to tolerate conventional therapy
- Has screening laboratory test results within the study protocol defined parameters
- A woman of childbearing potential must have a negative highly sensitive serum (beta human chorionic gonadotropin) pregnancy test result at screening and a negative urine pregnancy test result at Week 0
Exclusion Criteria:
- Has severe extensive colitis as defined in the study protocol
- Has UC limited to the rectum only or to less than (<) 20 centimeter (cm) of the colon
- Has a history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, before screening
- Has any known malignancy or has a history of malignancy (with the exception of basal cell carcinoma; squamous cell carcinoma in situ of the skin; or cervical carcinoma in situ that has been treated with no evidence of recurrence; or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years before screening)
- Has known allergies, hypersensitivity, or intolerance to guselkumab or golimumab or their excipients
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662542
Locations
Show 82 study locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
| Study Director: | Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC |
| Responsible Party: | Janssen Research & Development, LLC |
| ClinicalTrials.gov Identifier: | NCT03662542 |
| Other Study ID Numbers: |
CR108527 2018-001510-15 ( EudraCT Number ) CNTO1959UCO2002 ( Other Identifier: Janssen Research & Development, LLC ) |
| First Posted: | September 7, 2018 Key Record Dates |
| Last Update Posted: | January 3, 2022 |
| Last Verified: | December 2021 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Colitis Colitis, Ulcerative Ulcer Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Intestinal Diseases Pathologic Processes |
Inflammatory Bowel Diseases Golimumab Antibodies, Monoclonal Tumor Necrosis Factor Inhibitors Anti-Inflammatory Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |