NCT04963725 is a clinical trial of Ustekinumab in Ulcerative Colitis, sponsored by Janssen Pharmaceutical K.K..

Who is sponsoring NCT04963725?

NCT04963725 is sponsored by Janssen Pharmaceutical K.K..

What drugs are being tested in NCT04963725?

Interventions in NCT04963725: Ustekinumab.

What condition does NCT04963725 study?

NCT04963725 studies Ulcerative Colitis.

Is NCT04963725 still recruiting?

NCT04963725 is currently completed. Last updated 28 April 2025.

Last reviewed 2025-04-28 · How we verify

NCT04963725

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of Symptom Improvement of Ulcerative Colitis After an Induction Dose of Ustekinumab in Japanese Clinical Practice

Completed Last updated 28 April 2025

What this trial tests

trial testing Ustekinumab in Ulcerative Colitis in 137 participants. Completed in 1 December 2022.

Timeline

18 July 2021

Primary endpoint
1 December 2022

1 December 2022

Quick facts

Lead sponsor	Janssen Pharmaceutical K.K.
Status	Completed
Study type	OBSERVATIONAL
Enrollment	137
Start date	18 July 2021
Primary completion	1 December 2022
Estimated completion	1 December 2022
Sites	23 locations across Japan

Drugs / interventions tested

Ustekinumab (ustekinumab) — full drug profile →

Conditions studied

Ulcerative Colitis — all drugs for Ulcerative Colitis →

Sponsor

Janssen Pharmaceutical K.K. — full company profile →

Who can join

16 and older, any sex, with Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to describe the initial response to ustekinumab induction treatment for ulcerative colitis (UC) in Japan.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Immunology of Inflammatory Bowel Disease: Molecular Mechanisms and Therapeutics.
Lu Q, Yang MF, Liang YJ, Xu J, et al · · 2022 · cited 139× · PMID 35310454 · DOI 10.2147/jir.s353038
Context-Dependent Regulation of Type17 Immunity by Microbiota at the Intestinal Barrier.
Akuzum B, Lee JY. · · 2022 · cited 20× · PMID 36627936 · DOI 10.4110/in.2022.22.e46
Symptom Improvement of ulceRative colitis after an Induction dose of UStekinumab in Japanese clinical practice (SIRIUS), measured using patient-reported outcomes: a prospective observational study.
Matsuoka K, Nagano K, Nagasaki S, Murata Y, et al · · 2022 · cited 3× · PMID 35508346 · DOI 10.1136/bmjopen-2021-060081

Verify or expand the search:

Other trials of Ustekinumab

Trials testing the same drug.

NCT07268534 — Biologics in Folliculitis Decalvans : an Adaptative Trial Research · Phase 2 · not yet recruiting
NCT06807593 — Treatment of Immune Checkpoint Inhibitor-related Diarrhea and/ or Colitis With Ustekinumab in Cancer Patients · Phase 2 · recruiting
NCT07352566 — Utilization of a Microdevice for Psoriasis and Atopic Dermatitis · Phase 4 · not yet recruiting
NCT07177118 — Risankizumab for Fibrostenotic Crohn's Disease Treatment · Phase 3 · not yet recruiting
NCT07116967 — Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK) · Phase 3 · recruiting

Other recruiting trials for Ulcerative Colitis

Currently open trials in the same condition.

NCT07185009 — A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Acti · Phase 3 · recruiting
NCT07265570 — Study Evaluating ISM5411 Administered Orally to Subjects With Active Ulcerative Colitis (BETHESDA) · Phase 2 · recruiting
NCT07223424 — Patient Preference for Subcutaneous vs. Intravenous Immune Therapy · Phase 2 · recruiting
NCT06405087 — A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD · Phase 3 · recruiting
NCT07184996 — An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Activ · Phase 3 · recruiting

Other Janssen Pharmaceutical K.K. trials

Trials by the same sponsor.

NCT06295692 — A Study of JNJ-77242113 for the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis · Phase 3 · active not recruiting
NCT05926583 — A Study of AAV5-hRKp.RPGR for the Treatment of Japanese Participants With X-linked Retinitis Pigmentosa · Phase 3 · active not recruiting
NCT05567185 — A Study of Erdafitinib Intravesical Delivery System in Japanese Participants With Bladder Cancer · Phase 1 · active not recruiting
NCT05167825 — A Study of Macitentan in Japanese Pediatric Participants With Pulmonary Arterial Hypertension · Phase 3 · completed
NCT05242432 — A Study of Adenovirus Serotype 26.Respiratory Syncytial Virus.Pre-Fusion F (Ad26.RSV.preF)-Based Vaccine for Prevention · Phase 3 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04963725 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Janssen Pharmaceutical K.K.
Last refreshed: 28 April 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04963725.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing