drugset / Trial / NCT03662542
A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
RandomizedParallel-groupDouble-blindTreatment
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).
Timeline
- Start
- 2018-11-20
- Primary completion
- 2020-12-01
- Completion
- 2021-11-15
Outcome
Mixed primary results
paper The primary endpoint was clinical response at week 12 PMID 36738762 ↗
paper guselkumab monotherapy group (adjusted treatment difference 8·5% [-0·2 to 17·1; nominal p=0·2155) PMID 36738762 ↗
Publications
- Shao J, Vetter M, Vermeulen A, Feagan BG, Sands BE, Panes J, Xu Z. Combination Therapy With Guselkumab and Golimumab in Patients With Moderately to Severely Active Ulcerative Colitis: Pharmacokinetics, Immunogenicity and Drug-Drug Interactions. Clin Pharmacol Ther. 2024 Jun;115(6):1418-1427. doi: 10.1002/cpt.3235. Epub 2024 Mar 15.
- Feagan BG, Sands BE, Sandborn WJ, Germinaro M, Vetter M, Shao J, Sheng S, Johanns J, Panes J; VEGA Study Group. Guselkumab plus golimumab combination therapy versus guselkumab or golimumab monotherapy in patients with ulcerative colitis (VEGA): a randomised, double-blind, controlled, phase 2, proof-of-concept trial. Lancet Gastroenterol Hepatol. 2023 Apr;8(4):307-320. doi: 10.1016/S2468-1253(22)00427-7. Epub 2023 Feb 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Golimumab | Monoclonal antibody | 100 mg | Subcutaneous |
| Subject | Guselkumab | Monoclonal antibody | 100 mg | Intravenous |