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A Phase 3,Randomized,Placebo-controlled,Parallel-group,Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab in Participants with Fistulizing, Perianal Crohn's Disease
(FUZION CD)

A Study of Guselkumab in Participants with Fistulizing, Perianal Crohn's Disease (FUZION CD)

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

Recruiting

Aug. 22, 2022

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- Must have a diagnosis of Crohn's disease with a minimum duration of at least 3 months
- Has at least one active draining perianal fistula as a complication of Crohn's disease, confirmed by screening magnetic resonance imaging (MRI) results
- Has previously demonstrated lack of initial response (that is primary nonresponders), responded initially but then lost response with continued therapy (that is secondary non-responders), or were intolerant to a maximum of 2 classes of advanced drug therapies at a dose approved for the treatment of Crohn's disease (that is infliximab, adalimumab, certolizumab pegol,
vedolizumab, or approved biosimilars for these agents) or JAK inhibitors licensed for Crohn's disease treatment (that is, upadacitinib)

- Has a very severe luminal disease activity
- History of concurrent rectovaginal fistulas (other types of concurrent fistula should be confirmed with the sponsor), rectal and/or anal stenosis, stoma or functioning ostomy (include all current stoma types abscess or collections which are not properly drained) colonic mucosal dysplasia or pre-cancerous lesions that have not been removed, demyelinating disease, or systemic lupus erythematosus
- Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation that might be anticipated to require surgery or preclude fistula evaluation
- Any medical contraindications preventing study participation
- Has a history of ongoing, chronic or recurrent enteral or systemic infectious disease

Both

Fistulizing Crohns Disease Perianal Crohns Disease

'- Guselkumab:Drug:Group 1: Guselkumab:Group 2: Guselkumab:Group 3: Placebo:Guselkumab will be administered subcutaneously/IV infusion.
- Placebo:Drug:Group 1: Guselkumab:Group 2: Guselkumab:Group 3: Placebo:Matching placebo will be administered subcutaneously/IV infusion.
- Group 1:Guselkumab: Experimental: Participants will receive guselkumab Dose 1 intravenous (IV) infusion followed by Dose 2 subcutaneously (SC). Participants
will receive matching placebo to maintain the blind. Participants who are eligible and willing to continue guselkumab may enter the Long-Term Extension (LTE) period and continue to receive guselkumab.
- Group 2:Guselkumab: Experimental: Participants will receive guselkumab Dose 1 IV infusion followed by Dose 3 SC. Participants will receive matching placebo
to maintain the blind. At Week 24, guselkumab Dose 3 SC non-responders will switch to receive guselkumab dose 2 SC. Participants who are eligible and willing to continue guselkumab may enter the LTE period and continue to receive guselkumab.
- Group 3:placebp: Experimental: Participants will receive placebo IV infusion followed by placebo SC. At Week 24, placebo non-responders will continue to receive guselkumab Dose 4 followed by guselkumab Dose 2 SC. Participants will receive matching placebo to maintain the blind. Participants who are eligible and
willing to continue guselkumab may enter the LTE period and continue to receive guselkumab.

Percentage of Participants who Achieve Combined Fistula Remission at Week 24:Week 24:Percentage of participants who achieve combined fistula remission at Week 24 will be reported. Combined fistula remission is defined as 100 percentage (%) closure of all treated external openings without development of new fistulas or abscesses and without any drainage by the external openings [occurring spontaneously or after gentle finger compression] and absence of collections greater than (>) 2 centimeters (cm) of the perianal fistulas in at least two of three dimensions, confirmed by a blinded central review of the magnetic resonance imaging [MRI] results.

Refer to Appendix

July. 07, 2022

Yes

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/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

Australia/Spain/Italy/Saudi Arabia/Belgium/France/ Jordan/Sweden/Canada/United Kingdom Of Great Britain/Republic Of Korea/Turkiye/Czechia/Greece/Netherlands/Taiwan Province Of China/Germany/ Hungary/Poland/United States Of America/Egypt/ Israel/Portugal