An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease

Phase 1

• Conditions: Crohn's Disease; MedDRA version: 20.0Level: LLTClassification code 10011402Term: Crohn's disease (colon)System Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2018-004346-42-IT
• Lead Sponsor: ALLERGAN LIMITED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-24
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

1. Aged 16 to 80 years, inclusive, or minimum age of adult consent according to local regulations, at Screening. For participants less than 18years of age, the participant must weigh at least 40 kg at Screening.
2. Diagnosis of ileal, ileocolonic, or colonic CD with an onset of symptoms for a minimum of 3 months prior to Screening as determined by the investigator based on clinical history, exclusion of other etiologies including infectious causes, and characteristic endoscopic and/or histologic findings.
3. Moderately to severely active CD
4. Participant had an inadequate response or intolerance to intervention with oral CS, azathioprine, methotrexate, or 6- mercaptopurine, or demonstrated CS dependence for the treatment of CD.
5. Participants taking 5-aminosalicylates, Oral prednisone (or equivalent), Budesonide, Immunomodulators, Oral antibiotics, Probiotics must be at a stable dose.
6. Meets the following TB criteria: Participant has no known history of active TB; Participant has no known history of latent TB without completion of an appropriate course of intervention or is presently taking appropriate ongoing prophylactic intervention; Meets 1 of the following acceptable TB test results: Negative QFT-TB obtained from central laboratory within 4 weeks prior to randomization or For a positive QFT-TB test obtained during Screening from the central laboratory, active TB must be ruled out or Indeterminate QFT-TB test obtained during the Screening period from the central laboratory with ongoing QFT-TB testing; A negative tuberculin skin test is required if the QFT-TB test is not approved/registered in that country; Participants with a history of using anti-TNFa agents for a treatment course of 1 year or longer who have discontinued an anti-TNFa agent within 6 months prior to Screening must obtain a chest x-ray showing no evidence of active TB
within 8 weeks prior to Screening or during Screening.
7. Females of childbearing potential who are sexually active with a nonsterilized male partner must use 2 acceptable methods of contraception from Screening.
8. Female participants who are post-menopausal and of non-childbearing potential must have an elevated FSH at or above the range for postmenopausal women by the central laboratory during Screening.
9. Nonsterilized males who are sexually active with a female partner of childbearing potential must comply with the methods of contraception
10. Ability to provide written informed consent prior to any study procedures
11. Willingness and ability to attend all study visits, comply with the study procedures, read and write in order to complete questionnaires, and be able to complete the study period
Are the trial subjects under 18? yes
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 1250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 600

Exclusion Criteria

1. Partic has previously received Humira® and was intolerant to treat or had met the crit for prim or second non-resp to treat:
a. Primary non-resp: Signs and symptoms of persistently active disease despite a history of at least 1 induct regimen of H® per the local label consisting of at least 2 doses at least 2 w apart
b. Second non-resp: Recurrence of sympt of persistently active dis during scheduled maint dosing of H® per the local label following prior clinical benefit
c. Intol: AE associated with discontinuation of H® therapy, including, but not limited to, hypersensitivity, infusion-related reaction, inf, or congestive HF
2. Partic is unable or unwilling to have endoscopic proced performed during the study.
3. History or current diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, colonic mucosal dysplasia, primary sclerosing cholangitis, or untreated bile acid malabsorption.
4. History of toxic megacolon within 3 m prior to Basel (V 2).
5. Any intra-abdominal surgery, bowel resection, diversion, placement of ostomy or stoma within 3 m prior to Screening. Particip with a draining stoma are excluded.
6. Partic has an enterocutaneous or entovesicular fistula. Particip with active fistulas may be considered if there is no anticipation for surgery and there is no evidence of active infection (eg,
abscess) after further discussion with the study MM.
7. Bowel perforation during the 6 m prior to Screening or evidence of obstruction within 3 m of Screening.
8. Complications of CD including short bowel syndr, strictures/stenoses with obstruction or pre-stenotic dilation, or cond where surgery may be anticipated within 6 m, or other cond that may confound efficacy eval for the study.
9. Partic has any non-passable colonic stenosis/narrowing identified during the qualifying ileocolonoscopy (success endoscope passage to the caecum with inability to enter the endoscope into the ileum is not covered under this exclus criterion, and does not require
exclus).
10. Ongoing nutrit dependency for total parenteral nutrit or an elemental diet at Screening.
11. Partic has any of the following related to inf:
a. Evid of a recent (within 6 m of Basel [V 2]) systemic fungal inf, requiring inpatient hospit, and/or antifungal treatment. Partic treated for localized fungal infections (eg, oral, vaginal, and skin candidiasis, onychomycosis) are not excluded.
b. Any inf requiring hosp or treat with IV antiinfectives (including anti-viral treat) within 4 w of Screening
c. CMV or EBV infection that has not completely resolved within 8 w prior to Screening
d. Clin significant chronic inf (eg, osteomyelitis) that has not resolved within 8 w of Screening
e. Non-serious infect requiring oral anti-infectives within 2 w prior to random must be further discussed with the study MM. Chronic suppressive antiviral treatment for HSV in the absence of active lesions or uncomplicated urinary tract infections are not considered exclusionary.
f. Partic has clin evidence of or suspected to have an abscess during Screening. Cutaneous and perianal/perirectal abscesses are not exclusionary if drained and adequately treated at least 3 w prior to Screening.
g. Diagnosis of peritonitis or receiving treat for peritonitis within 8 w prior to Screening
h. Partic has any underlying condition that predisposes partic to infections
12. Previous allogenic bone marrow transplant or history of organ or cell-based transpl (eg, islet cell transpl or autol

Study & Design

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