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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03466411




Registration number
NCT03466411
Ethics application status
Date submitted
8/03/2018
Date registered
15/03/2018
Date last updated
22/05/2024

Titles & IDs
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
Secondary ID [1] 0 0
2017-002195-13
Secondary ID [2] 0 0
CR108387
Universal Trial Number (UTN)
Trial acronym
GALAXI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Guselkumab Dose 1
Treatment: Drugs - Guselkumab Dose 2
Treatment: Drugs - Guselkumab Dose 3
Treatment: Drugs - Guselkumab Dose 4
Treatment: Drugs - Guselkumab Dose 5
Treatment: Drugs - Guselkumab
Treatment: Drugs - Ustekinumab
Treatment: Drugs - Placebo

Experimental: Phase 2 (GALAXI 1): Group 1 (Guselkumab) - Participants will receive guselkumab (Dose 1) by intravenous (IV) infusion, followed by guselkumab (Dose 2) by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the Long-Term Extension (LTE) phase and continue to receive guselkumab.

Experimental: Phase 2 (GALAXI 1): Group 2 (Guselkumab) - Participants will receive guselkumab (Dose 3) by intravenous (IV) infusion, followed by guselkumab (Dose 2) by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the LTE phase and continue to receive guselkumab.

Experimental: Phase 2 (GALAXI 1): Group 3 (Guselkumab) - Participants will receive guselkumab (Dose 4) by intravenous (IV) infusion, followed by guselkumab (Dose 5) by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the LTE phase and continue to receive guselkumab.

Active Comparator: Phase 2 (GALAXI 1): Group 4 (Ustekinumab) - Participants will receive ustekinumab by intravenous (IV) infusion, followed by subcutaneous (SC) injection. Participants who are eligible and willing to continue ustekinumab may enter the LTE and continue to receive ustekinumab.

Experimental: Phase 2 (GALAXI 1): Group 5 (Placebo/Ustekinumab) - Participants will receive placebo administered by intravenous (IV) infusion. At Week 12, non-responders will receive active treatment (Ustekinumab) administered by intravenous (IV) infusion followed by subcutaneous (SC) injection. Participants who are eligible and willing to continue placebo/ustekinumab may enter the LTE and continue to receive placebo/ustekinumab.

Experimental: Phase 3 (GALAXI 2 and 3): Group 1 and Group 2 (Guselkumab) - Participants will receive guselkumab by intravenous (IV) infusion, followed by guselkumab by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the LTE phase and continue to receive guselkumab.

Active Comparator: Phase 3 (GALAXI 2 and 3): Group 3 (Ustekinumab) - Participants will receive ustekinumab by intravenous (IV) infusion, followed by subcutaneous (SC) injection. Participants who are eligible and willing to continue ustekinumab may enter the LTE phase and continue to receive ustekinumab.

Experimental: Phase 3 (GALAXI 2 and 3): Group 4 (Placebo/Ustekinumab) - Participants will receive placebo administered by intravenous (IV) infusion. At Week 12, non-responders will receive active treatment (ustekinumab) administered by intravenous (IV) infusion followed by subcutaneous (SC) injection. Participants who are eligible and willing to continue placebo/ustekinumab may enter the LTE and continue to receive placebo/ustekinumab.


Treatment: Drugs: Guselkumab Dose 1
Guselkumab will be administered by IV infusion.

Treatment: Drugs: Guselkumab Dose 2
Guselkumab will be administered by SC injection.

Treatment: Drugs: Guselkumab Dose 3
Guselkumab will be administered by IV infusion.

Treatment: Drugs: Guselkumab Dose 4
Guselkumab will be administered by IV infusion.

Treatment: Drugs: Guselkumab Dose 5
Guselkumab will be by SC injection.

Treatment: Drugs: Guselkumab
Guselkumab will be administered by IV infusion and SC injection.

Treatment: Drugs: Ustekinumab
Ustekinumab will be administered by IV infusion and SC injection.

Treatment: Drugs: Placebo
Placebo will be administered as IV infusion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 2: Change from Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12
Timepoint [1] 0 0
Baseline and Week 12
Primary outcome [2] 0 0
Phase 3: Clinical Response at Week 12 and Clinical Remission at Week 48
Timepoint [2] 0 0
Baseline to Week 48
Primary outcome [3] 0 0
Phase 3: Clinical Response at Week 12 and Endoscopic Response at Week 48
Timepoint [3] 0 0
Baseline to Week 48
Secondary outcome [1] 0 0
Phase 2: Clinical Remission at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Phase 2: Clinical Response at Week 12
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Phase 2 and Phase 3: Patient-Reported Outcome (PRO)-2 Remission at Week 12
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Phase 2: Clinical-Biomarker Response at Week 12
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Phase 2: Endoscopic Response at Week 12
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Phase 3: Clinical Response at Week 4
Timepoint [6] 0 0
Week 4
Secondary outcome [7] 0 0
Phase 3: Clinical Remission at Week 12
Timepoint [7] 0 0
Week 12
Secondary outcome [8] 0 0
Phase 3: Endoscopic Response at Week 12
Timepoint [8] 0 0
Week 12
Secondary outcome [9] 0 0
Phase 3: Fatigue Response at Week 12
Timepoint [9] 0 0
Week 12
Secondary outcome [10] 0 0
Phase 3: Clinical Remission at Week 12 and Endoscopic Response at Week 12
Timepoint [10] 0 0
Week 12
Secondary outcome [11] 0 0
Phase 3: Endoscopic Remission at Week 12
Timepoint [11] 0 0
Week 12
Secondary outcome [12] 0 0
Phase 3: Clinical Response at Week 12 and Corticosteroid-Free Clinical Remission at Week 48
Timepoint [12] 0 0
Baseline to Week 48
Secondary outcome [13] 0 0
Phase 3:Clinical Response at Week 12 and Endoscopic Remission at Week 48
Timepoint [13] 0 0
Baseline to Week 48
Secondary outcome [14] 0 0
Phase 3: Clinical Remission at Week 48
Timepoint [14] 0 0
Week 48
Secondary outcome [15] 0 0
Phase 3: Endoscopic Response at Week 48
Timepoint [15] 0 0
Week 48
Secondary outcome [16] 0 0
Phase 3: Clinical Remission at Week 48 and Endoscopic Response at Week 48
Timepoint [16] 0 0
Week 48
Secondary outcome [17] 0 0
Phase 3: Endoscopic Remission at Week 48
Timepoint [17] 0 0
Week 48
Secondary outcome [18] 0 0
Phase 3: Deep Remission at Week 48
Timepoint [18] 0 0
Week 48

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

- Any medical contraindications preventing study participation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2/Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/04/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2030
Actual
Sample size
Target
Accrual to date
Final
1409
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Queen Elizabeth Hospital - Adelaide
Recruitment hospital [2] 0 0
Monash Health, Monash Medical Centre - Clayton
Recruitment hospital [3] 0 0
Concord Hospital - Concord
Recruitment hospital [4] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [5] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [6] 0 0
Royal Adelaide Hospital - North Terrace
Recruitment hospital [7] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [8] 0 0
Nepean Hospital - Penrith
Recruitment hospital [9] 0 0
The Alfred Hospital - Prahran
Recruitment hospital [10] 0 0
Mater Hospital Brisbane - South Brisbane
Recruitment hospital [11] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
5011 - Adelaide
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
2139 - Concord
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3084 - Heidelberg
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6009 - Nedlands
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5000 - North Terrace
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3050 - Parkville
Recruitment postcode(s) [8] 0 0
2751 - Penrith
Recruitment postcode(s) [9] 0 0
3004 - Prahran
Recruitment postcode(s) [10] 0 0
4101 - South Brisbane
Recruitment postcode(s) [11] 0 0
4102 - Woolloongabba
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the clinical efficacy (GALAXI 1), clinical and
endoscopic efficacy (GALAXI 2 and GALAXI 3) and safety of guselkumab in participants with
Crohn's disease.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03466411
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03466411