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A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants with Moderately to Severely Active Ulcerative Colitis (ASTRO)

A Study of Guselkumab Therapy in Participants with Moderately to Severely Active Ulcerative Colitis (ASTRO)

Sakamoto Takehiko

Janssen Pharmaceutical K.K.

5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo

DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com

Medical Information Center

Janssen Pharmaceutical K.K.

5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo

+81-120-183-275

DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com

Not Recruiting

Dec. 19, 2022

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- Signed informed consent form
- 18 years of age or older
- Documented diagnosis of ulcerative colitis (UC) at least 12 weeks prior to screening
- Moderately to severely active UC as per the modified Mayo score
- Demonstrated inadequate response to or intolerance of conventional therapy and/or advanced therapy as defined in
the protocol

- Diagnosis of indeterminate colitis, microscopic colitis,
ischemic colitis, or Crohn's disease
- Surgery within 8 weeks before screening or planned
surgery during the study that may confound the evaluation
of benefit from study intervention
- Receiving prohibited medications and treatments

Both

Colitis, Ulcerative

Guselkumab Dose 1:Drug:Group 1: Guselkumab:Group 2: Guselkumab:Guselkumab (Dose 1) will be administered as SC injection.
Guselkumab Dose 2:Drug:Group 1: Guselkumab:Guselkumab (Dose 2) will be administered as SC injection.
Guselkumab Dose 3:Drug:Group 2: Guselkumab:Guselkumab (Dose 3) will be administered as SC injection.
Placebo:Other:Group 3: Placebo:Placebo will be administered as SC injection.

Clinical Remission:Week 12:Clinical remission per modified Mayo score.

- Symptomatic Remission: Week 12 and 24: Symptomatic remission per Mayo score is defined as a stool frequency subscore of 0 (normal number of stools) or 1 (1 to 2 stools more than normal) and a rectal bleeding subscore of 0 (no blood seen).
- Endoscopic Improvement: Week 12 and 24: Endoscopic improvement per Mayo endoscopy subscore.
- Clinical Response:Week 12 and 24:Clinical response per modified Mayo score.
- Clinical Remission:Week 24: Clinical remission per stool frequency and rectal bleeding subscores.
- Histologic-Endoscopic Mucosal Improvement:Week 12:Histologic-endoscopic mucosal improvement is defined as a combination of histologic improvement according to the Geboes grading system and endoscopic improvement (Mayo endoscopy subscore of 0 or 1 without friability).
- Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation of Study Intervention:Up to Week 268:Percentage of participants with AEs, SAEs and AEs leading to discontinuation of study intervention will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Sept. 09, 2022

Yes

The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

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