Ustekinumab 90 mg SC q12w

BIOLOGICAL2 trials

Conditions

ColitisCrohn Disease (CD)Crohn's DiseaseIBDInflammatory Bowel DiseaseUlcerative Colitis (UC)

Phase 3

A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease (IM-UNITI)

CompletedNCT01369355

Janssen Research & Development, LLCColitis, Crohn's Disease, IBD +1

Start: 2011-09-13End: 2019-10-01Updated: 2025-02-04

Phase 4

De-escalation of Ustekinumab Therapy in Patients With Crohn's Disease and Ulcerative Colitis

RecruitingNCT07303686

McGill University Health Centre/Research Institute of the McGill University Health CentreCrohn Disease (CD), Ulcerative Colitis (UC)

Start: 2025-10-08End: 2027-10-15Target: 115Updated: 2025-12-26

2026-07-10

Safety of Ustekinumab in Inflammatory Bowel Disease: Pooled Safety Analysis Through 5 Years in Crohn's Disease and 4 Years in Ulcerative Colitis.

2024-08-0118 citations

Evolution of Symptoms After Ustekinumab Induction Therapy in Patients With Crohn’s Disease

Clinical Gastroenterology and Hepatology2023-06-289 citations

Matching-Adjusted Indirect Comparison Between Risankizumab and Ustekinumab for Induction and Maintenance Treatment of Moderately to Severely Active Crohn's Disease.

2023-06-2710 citations

Population Pharmacokinetics and Exposure-Response Analyses of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease.

2022-09-2129 citations

The impact of ustekinumab on extraintestinal manifestations of Crohn's disease: A <i>post hoc</i> analysis of the UNITI studies

United European Gastroenterology Journal2021-06-0133 citations

Ustekinumab in Paediatric Patients with Moderately to Severely Active Crohn’s Disease: Pharmacokinetics, Safety, and Efficacy Results from UniStar, a Phase 1 Study

Journal of Crohn s and Colitis2021-05-2461 citations

Five-Year Efficacy and Safety of Ustekinumab Treatment in Crohn's Disease: The IM-UNITI Trial.

2021-02-19154 citations

Safety of Ustekinumab in Inflammatory Bowel Disease: Pooled Safety Analysis of Results from Phase 2/3 Studies

Inflammatory Bowel Diseases2020-09-23112 citations

Week 6 Calprotectin Best Predicts Likelihood of Long-term Endoscopic Healing in Crohn’s Disease: A Post-hoc Analysis of the UNITI/IM-UNITI Trials

Journal of Crohn s and Colitis2020-09-1122 citations

Body Mass Index Does Not Impact Clinical Efficacy of Ustekinumab in Crohn’s Disease: A Post Hoc Analysis of the IM-UNITI Trial

Inflammatory Bowel Diseases2020-08-1926 citations

Effects of Ustekinumab on Histologic Disease Activity in Patients With Crohn’s Disease

Gastroenterology2019-07-0465 citations

IM-UNITI: Three-year Efficacy, Safety, and Immunogenicity of Ustekinumab Treatment of Crohn’s Disease

Journal of Crohn s and Colitis2019-06-01205 citations

Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn’s Disease: An Integrated Analysis of Phase II/III Clinical Development Programs

Drug Safety2019-02-08114 citations

Efficacy of Ustekinumab for Inducing Endoscopic Healing in Patients With Crohn's Disease.

2018-08-29139 citations

Long‐term efficacy and safety of ustekinumab for Crohn's disease through the second year of therapy

Alimentary Pharmacology & Therapeutics2018-05-24178 citations

Pharmacokinetics and Exposure Response Relationships of Ustekinumab in Patients With Crohn's Disease.

2018-02-01188 citations

Efficacy and safety of ustekinumab in Japanese patients with moderately to severely active Crohn's disease: a subpopulation analysis of phase 3 induction and maintenance studies

Intestinal Research2017-01-0123 citations

Ustekinumab as Induction and Maintenance Therapy for Crohn's Disease.

2016-11-011340 citations

Vedolizumab as Induction and Maintenance Therapy for Crohn's Disease

New England Journal of Medicine2013-08-212650 citations

Ustekinumab 90 mg SC q12w

Sponsors

Conditions

Phase 3

Phase 4

Related Papers