A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis

• Register: EUCTR
• Last refreshed on: 11 March 2020
• Main ID: EUCTR2018-004002-25-ES
• Date of registration: 04/09/2019
• 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 Ulcerative Colitis
• Scientific title: A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR
• Date of first enrolment: 28/02/2020
• Target sample size: 1000
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-004002-25
• 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: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 6
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Belgium, Bulgaria, Canada, China, Czech Republic, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Korea, Republic of, Malaysia, Netherlands, Poland, Portugal, Russian Federation, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: Global Clinical Operations Spain
• Affiliation: Janssen Cilag, S.A.

• Name: Global Clinical Operations Spain
• Affiliation: Janssen Cilag, S.A.

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male or female, 18 years of age or older
2. Documented diagnosis of UC at least 3 months before screening
3. Moderately to severely active UC as defined by baseline modified Mayo score
4. History of inadequate response to or failure to tolerate conventional or advanced therapy as defined in the protocol
5. Screening laboratory test results within the study protocol defined parameters

Please see section 5.1 in the protocol for all inclusion criteria.
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 900
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion criteria:
1. Severe extensive colitis as defined in the study protocol
2. UC limited to the rectum only
3. Presence of a stoma
4. Presence or history of a fistula
5. Presence of symptomatic colonic or small bowel obstruction
6. History of extensive colonic resection
7. History of colonic mucosal dysplasia
8. Indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease or clinical findings suggestive of Crohn's disease.

Please see section 5.2 in the protocol for all exclusion criteria.


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

Health Condition(s) or Problem(s) studied

Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

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 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 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: guselkum

Primary Outcome(s)

Secondary Objective: - To evaluate the impact of guselkumab on health-related quality of life (HRQoL) and health economics outcome measures.
- To evaluate the PK, immunogenicity, and pharmacodynamics (PD) of guselkumab therapy, including changes in C-reactive protein (CRP) and fecal calprotectin.

Main Objective: To evaluate the efficacy and safety of guselkumab in moderately to severely active UC.

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

Primary end point(s): Induction study 1:
Clinical response at Week 12

Induction study 2:
Clinical remission at Week 12

Maintenance study:
Clinical remission at Week 52

Secondary Outcome(s)

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

Secondary end point(s): Maintenance study
· Symptomatic remission at Week 52
· Endoscopic healing at Week 52
· Corticosteroid-free clinical remission at Week 52
· Clinical response at Week 52
· Histo-endoscopic healing at Week 52
· Clinical remission at Week 52 among the participants who had achieved clinical remission at maintenance baseline

Secondary ID(s)

2018-004002-25-SE

CNTO1959UCO3001

Source(s) of Monetary Support

Janssen Research & Development

Ethics review

Status: Approved
Approval date: 21/02/2020
Contact: