Efficacy and Safety of Guselkumab in Participants with Fistulizing, Perianal Crohn's Disease

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Janssen - Cilag International

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

22 Nov 2022 → ongoing

Decision date (initial)

2024-08-13

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Janssen Research & Development, United States

External identifiers

EU CT number

2023-504740-33-00

EudraCT number

2021-000491-10

ClinicalTrials.gov

NCT05347095

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Safety, Pharmacokinetic, Efficacy, Pharmacodynamic, Pharmacogenetic, Pharmacogenomic

To evaluate the clinical efficacy of guselkumab in fistulizing, perianal Crohn's disease

Conditions and MedDRA coding

Fistulizing perianal Crohn's Disease

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

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

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Aged 18 years or over
2. Diagnosis of Crohn's disease with a minimum duration of at least 3 months
3. At least one active draining perianal fistula as a complication of Crohn's disease, confirmed by screening MRI results
4. Has previously demonstrated lack of initial response, responded initially but then lost response with continued therapy, or were intolerant to a maximum of 2 classes of biologic agents at a dose approved for the treatment of Crohn's disease. OR History of failure to respond to, or tolerate, at least 1 of the following therapies for the treatment of Crohn's disease: oral corticosteroids (including budesonide and beclomethasone dipropionate) or immunomodulators (AZA, 6-MP, MTX).
5. Had a history of failure to respond to, or tolerate, at least 1 of the following therapies for fistula treatment: antibiotics (ie, ciprofloxacin, metronidazole) and/or immunomodulators (AZA, 6-MP, MTX).

Exclusion criteria 3

1. Has a very severe luminal disease activity (defined as CDAI ≥350).
2. Has any of the following: - history of or concurrent rectovaginal fistulas, rectal and/or anal stenosis, stoma or functioning ostomy. - colonic mucosal dysplasia or pre-cancerous lesions that have not been removed, demyelinating disease, or systemic lupus erythematosus.
3. Has current complications of Crohn's disease, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation, that might be anticipated to require surgery, could preclude any fistula evaluation (both clinical and radiological) to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with guselkumab.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint of this study is the proportion of participants who achieve combined fistula remission at Week 24

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Placebo 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Janssen - Cilag International

Sponsor organisation

Janssen - Cilag International

Address

Turnhoutseweg 30

City

Beerse

Postcode

2340

Country

Belgium

Scientific contact point

Organisation

Janssen - Cilag International

Contact name

CTIS Point of Contact

Public contact point

Organisation

Janssen - Cilag International

Contact name

CTIS Point of Contact

Third parties 12

Locations

11 EU/EEA countries · 58 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 195 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications