Optimal Care with Guselkumab in Crohn’s Disease

Overview

Sponsor-declared trial summary

Key facts

Sponsor

i-GETAID

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Decision date (initial)

2026-04-16

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Janssen

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

To evaluate the one-year effectiveness of GUS in CD in real-world setting

Secondary objectives 3

1. To evaluate the effectiveness of GUS intensification from 100 mg q8w to 200 mg q4w in patients with loss of response
2. To evaluate the effectiveness of an intensified GUS 200 mg q4w maintenance therapy in patients who are primary non-responders to GUS SC induction at 12 week
3. To assess the factors associated with GUS intensification effectiveness

Conditions and MedDRA coding

Crohn's disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Patients with a diagnosis of Crohn's disease according to ECCO guidelines
2. Absence of contraindication to guselkumab
3. Active disease according to PRO2 (abdominal pain > 1 or stool frequency > 3), and faecal calprotectin > 250 ug/g
4. Objective active disease (as defined by endoscopy, MRI or IUS) within ≤ 2 month
5. 18 years of age or older at the time of informed consent
6. Not currently participating in any interventional research
7. Naïve or exposed to one or more advanced therapy

Exclusion criteria 6

1. Previous exposure to an anti-IL23
2. Combination of an advanced therapy with guselkumab
3. Patient with ostomy
4. Pregnant or breastfeeding woman
5. Patient with perianal Crohn's disease predominant disease
6. Patients under legal protection

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Steroid free clinical remission (SFCR) associated with fecal calprotectin < 250 ug/g at W48

Secondary endpoints 7

1. Morphological remission at W48 assessed using the same tool that was used for the patient’s inclusion: endoscopy, MRI or IUS (major secondary endpoint)
2. SFCR associated with fecal calprotectin < 250 ug/g at W12, W24 and W48
3. Clinical remission at W12, W24, and W48
4. Clinical response at W12
5. Biomarker remission at W12, W24, and W48
6. Need for guselkumab dose intensification (W12, W24, W48)
7. Change in Short IBD-Q (quality of life index) from baseline (W12, W24, and W48)

Investigational products

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

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

i-GETAID

Sponsor organisation

i-GETAID

Address

50 Rue Richer

City

Paris

Postcode

75009

Country

France

Scientific contact point

Organisation

i-GETAID

Contact name

MATHURIN FUMERY

Public contact point

Organisation

i-GETAID

Contact name

MATHURIN FUMERY

Locations

1 EU/EEA country · 31 investigational sites

By country

Investigational sites

Results and documents

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

Documents 7 files

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

Application history

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