A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease

• Register: EUCTR
• Last refreshed on: 8 August 2022
• Main ID: EUCTR2017-002195-13-AT
• Date of registration: 18/04/2018
• Prospective Registration: Yes
• Primary sponsor: Janssen-Cilag International NV
• Public title: A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease
• Scientific title: A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI
• Date of first enrolment: 28/05/2018
• Target sample size: 2000
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-002195-13
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: yes; Other: no; Number of treatment arms in the trial: 9
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Canada, China, Colombia, Croatia, Czech Republic, Czechia, France, Georgia, Germany, Greece, Hungary, Israel, Italy, Japan, Jordan, Korea, Republic of, Latvia, Lebanon, Lithuania, Netherlands, New Zealand, North Macedonia, Poland, Portugal, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Taiwan, Tunisia, Turkey, Ukraine, United Kingdom, United States

Contacts

• Affiliation: PAREXEL International LLC

• Affiliation: PAREXEL International LLC

Key inclusion & exclusion criteria

Inclusion criteria:
- Have Crohn’s disease (CD) or fistulizing Crohn’s disease of at least 3 months duration (defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy
- Have moderate to severe CD as assessed by CDAI, stool frequency (SF), and abdominal pain (AP) scores, and Simple Endoscopic Score for Crohn's Disease (SES-CD)
- Have screening laboratory test results within the protocol specified parameters
- A female participant of childbearing potential must have a negative urine pregnancy test result at screening and baseline
- Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1800
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion criteria:
- Current diagnosis of ulcerative colitis or indeterminate colitis
- Has complications of Crohn’s disease, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation
- Unstable doses of concomitant Crohn's disease therapy
- Receipt of Crohn’s disease approved biologic agents, investigational agents, or procedures outside of permitted timeframe as specified in the protocol
- Prior exposure to p40 inhibitors or p19 inhibitors
- Any medical contraindications preventing study participation


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders

Intervention(s)

Product Name: guselkumab
Product Code: CNTO1959
Pharmaceutical Form: Solution for infusion in pre-filled syringe
INN or Proposed INN: GUSELKUMAB
Current Sponsor code: CNTO 1959
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection/infusion in pre-filled syringe
Route of administration of the placebo: Intravenous use

Product Name: guselkumab
Product Code: CNTO1959
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Guselkumab
Current Sponsor code: CNTO 1959
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection/infusion in pre-filled syringe
Route of administration of the placebo: Intravenous use

Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ustekinumab
CAS Number: 815610-63-0
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ustekinumab
CAS Number: 815610-63-0
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Secondary Objective: Phase 2:
- To evaluate the dose-response of guselkumab to inform dose selection for the Phase 3 portion of this protocol
- To evaluate the efficacy of guselkumab on endoscopic improvement
- To evaluate the PK, immunogenicity, and pharmacodynamics (PD) of guselkumab therapy

Phase 3:
- To evaluate the impact of guselkumab on HRQOL
- To evaluate the PK, immunogenicity, and PD of guselkumab therapy

Primary end point(s): Phase 2: Change from Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12
Phase 3 co-primary endpoints:
- Clinical remission at week 12 (defined as CDAI score <150)
- Endoscopic response at week 12

Timepoint(s) of evaluation of this end point: week 12

Main Objective: Phase 2:
- To evaluate the clinical efficacy of guselkumab in participants with Crohn’s disease
- To evaluate the safety of guselkumab

Phase 3:
- To evaluate the clinical and endoscopic efficacy of guselkumab in participants with Crohn’s disease
- To evaluate the safety of guselkumab

Secondary Outcome(s)

Secondary end point(s): Phase 2:
- Clinical remission at Week 12 (defined as CDAI score <150)
- Clinical response at Week 12 (defined as =100-point reduction from baseline in CDAI score or CDAI score <150)
- PRO-2 remission at Week 12 (defined based on average daily stool frequency (SF) and average daily abdominal pain (AP) score)
- Clinical-biomarker response at Week 12 (clinical response based on CDAI score and reduction from baseline in CRP or fecal calprotectin)
- Endoscopic response at Week 12 (measured by the Simple Endoscopic Score for Crohn's
Disease (SES-CD). The SES-CD is based on the evaluation of 4 endoscopic components across 5 ileocolonic segments, with a total score ranging from 0 to 56.)

Phase 3:
- Clinical remission at Week 48 (defined as CDAI < 150)
- Endoscopic response at Week 48
- Durable clinical remission at Week 48 (defined as CDAI<150 for the majority of visits between Week 12 and Week 48.)
- Corticosteroid-free clinical remission at Week 48 (defined as CDAI score <150 at Week 48 and not receiving corticosteroids at Week 48)
- PRO-2 remission at Week 12 and 48 (based on average daily stool frequency (SF) and average daily abdominal pain (AP) score)
- Endoscopic response at Week 12 and 48 (measured by the Simple Endoscopic Score for Crohn's Disease (SES-CD))
- Fatigue response at Week 12 (based on the PROMIS Fatigue Short Form 7a)

Timepoint(s) of evaluation of this end point: week 12 or 48 as listed above

Secondary ID(s)

CNTO1959CRD3001

2017-002195-13-GB

Source(s) of Monetary Support

Janssen Research & Development

Ethics review

Status: Approved
Approval date: 08/05/2018
Contact: