A clinical study to evaluate the safety and effectiveness of JNJ-64304500 as an add-on therapy to standard of care biologic therapy with anti-tumor necrosis factor alpha or anti-interleukin 12/23 in responder not remitter participants with active Crohn's Disease

• Register: EUCTR
• Last refreshed on: 26 April 2021
• Main ID: EUCTR2020-002701-26-IT
• Date of registration: 07/04/2021
• Prospective Registration: No
• Primary sponsor: JANSSEN CILAG INTERNATIONAL NV
• Public title: A clinical study to evaluate the safety and effectiveness of JNJ-64304500 as an add-on therapy to standard of care biologic therapy with anti-tumor necrosis factor alpha or anti-interleukin 12/23 in responder not remitter participants with active Crohn's Disease
• Scientific title: A Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Proof-of-Concept Clinical Study to Evaluate the Safety and Efficacy of JNJ-64304500 as Add-on Therapy to Standard of Care Biologic Therapy with Anti-Tumor Necrosis Factor Alpha or Anti-Interleukin 12/23 in Responder Not Remitter Participants with Active Crohn's Disease - DUET
• Date of first enrolment: 12/01/2021
• Target sample size: 70
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-002701-26
• 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: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Canada, France, Germany, Italy, Japan, Spain, Sweden, United States

Contacts

• Name: Clinical Registry group
• Affiliation: Janssen-Cilag International NV

• Name: Clinical Registry group
• Affiliation: Janssen-Cilag International NV

Key inclusion & exclusion criteria

Inclusion criteria:
Each potential participant must satisfy all of the following criteria to be enrolled in the study:
1. male or female, 18 to 65 years old (inclusive).
2. have confirmed clinical diagnosis of Crohn's disease or fistulizing Crohn's disease of at least 3 months' duration.
3. initiated SOC biologic therapy
- Adalimumab (including HUMIRA or an equivalent biosimilar which could include: HULIO, HYRIMOZ, IMRALDI, or AMGEVITA) at maintenance dose of 40 mg SC q2w
or
- Ustekinumab at maintenance dose of 90 mg SC q8w
4. have healthcare provider documentation of suboptimal response to SOC biologic therapy with no documented deterioration or clinical remission during current treatment.
5. do not have clinically relevant immunogenicity to participant's current SOC biologic therapy at screening.

Please refer to 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 63
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7

Exclusion criteria:
Any potential participant who meets any of the following criteria will be excluded from participating in the study:
1. has complications of Crohn's disease that could confound the effect of treatment.
2. currently has or is suspected to have abscess
3. has had any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months before baseline
4. has a draining, stoma or ostomy.
5. has had a central line within 12 weeks before first dose

Please refer to protocol for all the exclusion criteria.


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

Health Condition(s) or Problem(s) studied

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

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: JNJ-64304500
Product Code: [JNJ-64304500]
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: JNJ-64304500
Current Sponsor code: JNJ-64304500
Other descriptive name: sezione * D.3.6.2.1 - valore: 400mg alla settimana 0, in seguito 200mg ogni due settimane
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Main Objective: 1. To evaluate safety and tolerability at Week 12
2. To evaluate efficacy at Week 12 (change in Crohn's Disease Activity Index [CDAI] score from baseline)

Secondary Objective: 1. To evaluate clinical response/remission at Week 12
2. To evaluate pharmacokinetics (PK), immunogenicity and pharmacodynamics (PD)/biomarkers at Week 12

Timepoint(s) of evaluation of this end point: 1. Throughout the study
2. Week 12

Primary end point(s): 1. Descriptive analyses of adverse events (AEs), clinical laboratory tests, and vital signs at Week 12 and applicable visits from Week 0 through Week 26
2. Change from baseline in the CDAI score at Week 12.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1. at Week 12
2. Week 0 through Week 26

Secondary end point(s): 1. Analyses of the following at Week 12:
- Proportion of participants achieving a clinical response.
- Proportion of participants achieving a clinical remission.
- Change in the simple endoscopic score for Crohn's disease (SES-CD) from baseline.
- Proportion of participants achieving an endoscopic response
- Proportion of participants achieving an endoscopic remission
- Change in abdominal pain (AP) from baseline at all postbaseline visits
- Proportion of participants achieving a Patient-Reported Outcome (PRO)-2 remission
2. Analyses of the following at all applicable visits from Week 0 through Week 26:
- Serum concentrations of investigational drug
- Incidence and titers of antibodies to investigational drug.
- Incidence of neutralizing antibodies to investigational drug.
- Change in PD biomarker levels.

Secondary ID(s)

64304500CRD2002

Source(s) of Monetary Support

Janssen-Cilag S.p.A.

Janssen Research & Development, LLC

Ethics review

Status: Approved
Approval date: 12/01/2021
Contact: