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

Phase 1

• Conditions: Active Crohn's Disease; MedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2020-002701-26-IT
• Lead Sponsor: JANSSEN CILAG INTERNATIONAL NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-07
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified