A 52-Week, Multicenter, Randomized, Double-blind, Placebo and Active-Controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease (INTREPID Lead-In)

Who is this study for? Young adult to adult patients with Ileal, Ileocolonic, or Colonic Crohn's Disease
What treatments are being studied? Brazikumab
Status: Terminated
Location: See all (97) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

This study seeks to evaluate the safety and efficacy of brazikumab versus placebo (Stage I) and versus an active comparator (Stage 2) in participants with moderately to severely active CD and will include assessments of clinical response as demonstrated by improvement of symptoms and colonic mucosal appearance as observed on endoscopy

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• At the time of signing the informed consent, the participant must be 18 to 80 years of age, inclusive.

• A 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.

• Moderately to severely active CD defined by a CDAI score of 220 to 450 AND; CDAI LSF score ≥ 5 OR CDAI AP score ≥ 2; AND SES-CD of at least 6

• Participant had an inadequate response or intolerance to intervention with conventional treatment \[oral aminosalicylates, oral CS, azathioprine, methotrexate, or 6-mercaptopurine\], or prior biological treatment, or demonstrated CS dependence for the treatment of CD. For participants who have previously used biological treatment, a participant may have failed up to 3 biologics that include up to 2 different mechanisms of action.

• Participants taking 5-aminosalicylates, Oral prednisone (or equivalent), Budesonide, Immunomodulators, Oral antibiotics, Immunomodulators, Probiotics must be at a stable dose.

• Participant must have the QFT-TB test performed and meet the following TB criteria.

⁃ A TB worksheet must also be completed:

• Participant has no known history of active TB.

• Participant has no known history of latent TB without completion of an appropriate course of intervention.

• Meets 1 of the following acceptable TB test results:

⁃ i. Negative QFT-TB obtained from central laboratory during Screening, OR ii. For a positive QFT-TB test obtained during Screening from the central laboratory, active TB must be ruled out or treated and negative QFT-TB confirmed by central laboratory OR iii. Indeterminate QFT-TB test obtained during the Screening Period from the central laboratory with ongoing QFT-TB testing as outlined in Appendix G. Participants with an indeterminate QFT-TB test can continue with Screening if they have all of the following:

• no symptoms/risk factors per TB worksheet provided by the sponsor

• no known recent exposure to a case of active TB

• no evidence of active TB on chest x-ray within 8 weeks prior to Screening or during Screening

• confirmed QFT-TB negative by central laboratory

⁃ 7 Female participants of childbearing potential must have a negative urine pregnancy test prior to administration of study intervention and must agree to use a highly effective method of birth control (confirmed by the investigator) from randomization throughout the study duration and for at least 18 weeks after last dose of study intervention.

⁃ 8 Women not of childbearing potential are defined as women who are either permanently sterilized or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrhoeic for 12 months prior to the planned date of randomization without an alternative medical cause.

⁃ 9 Nonsterilized males who are sexually active with a female partner of childbearing potential must comply with the methods of contraception during treatment and until the end of relevant systemic exposure in the male participant, plus a further 18 weeks.

⁃ 10 Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.

⁃ 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.

⁃ 12 Provision of signed and dated written Optional Genetic Research Information informed consent prior to collection of samples for optional genetic research that supports Genomic Initiative.

⁃ Complete inclusion criteria are in the study protocol

Locations
United States
Arkansas
Research Site
Little Rock
Arizona
Research Site
Phoenix
California
Research Site
Lancaster
Research Site
Lincoln
Research Site
Poway
Research Site
San Diego
Colorado
Research Site
Colorado Springs
Florida
Research Site
Boca Raton
Research Site
Clearwater
Research Site
Kissimmee
Research Site
Lakeland
Research Site
Miami
Research Site
Miami
Research Site
Miami
Research Site
Miami Lakes
Research Site
Naples
Research Site
St. Petersburg
Research Site
Tampa
Georgia
Research Site
Atlanta
Research Site
Atlanta
Research Site
Decatur
Illinois
Research Site
Oak Lawn
Indiana
Research Site
Brownsburg
Michigan
Research Site
Chesterfield
North Carolina
Research Site
Morehead City
New Mexico
Research Site
Albuquerque
Nevada
Research Site
Las Vegas
Ohio
Research Site
Beachwood
Oklahoma
Research Site
Oklahoma City
Pennsylvania
Research Site
Uniontown
Texas
Research Site
Carrollton
Research Site
Houston
Research Site
Houston
Research Site
Mcallen
Research Site
Pflugerville
Research Site
Stafford
Virginia
Research Site
North Chesterfield
Washington
Research Site
Spokane
Other Locations
Canada
Research Site
Chicoutimi
Research Site
New Westminster
Germany
Research Site
Augsburg
Research Site
Berlin
Research Site
Hamburg
Research Site
Kiel
Research Site
Minden
Research Site
Remscheid
Research Site
Ulm
Hungary
Research Site
Budapest
India
Research Site
Bangalore
Research Site
Hyderabad
Research Site
Jaipur
Research Site
Surat
Israel
Research Site
Haifa
Research Site
Jerusalem
Research Site
Petah Tikva
Italy
Research Site
Milan
Research Site
Milan
Research Site
Padua
Poland
Research Site
Bydgoszcz
Research Site
Chojnice
Research Site
Krakow
Research Site
Poznan
Research Site
Rzeszów
Research Site
Sopot
Research Site
Torun
Research Site
Warsaw
Research Site
Warsaw
Research Site
Warsaw
Research Site
Wroclaw
Research Site
Zamość
Republic of Korea
Research Site
Busan
Research Site
Daegu
Research Site
Seoul
Research Site
Seoul
Russian Federation
Research Site
Aramil
Research Site
Moscow
Research Site
Perm
Slovakia
Research Site
Banská Bystrica
Research Site
Košice
Research Site
Nitra
South Africa
Research Site
Cape Town
Research Site
Cape Town
Research Site
Johannesburg
Research Site
Plumstead
Spain
Research Site
Madrid
Research Site
Pontevedra
Research Site
Valencia
Taiwan
Research Site
Kaohsiung City
Research Site
Taichung
Research Site
Taipei
Research Site
Taipei
Ukraine
Research Site
Kharkiv
Research Site
Kyiv
Research Site
Kyiv
Research Site
Kyiv
United Kingdom
Research Site
Coventry
Research Site
West Bromwich
Time Frame
Start Date: 2018-12-07
Completion Date: 2023-10-18
Participants
Target number of participants: 89
Treatments
Experimental: (Stage 1) Brazikumab high dose
Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48
Experimental: (Stage 1) Brazikumab low dose
Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48
Placebo_comparator: (Stage 1) Placebo
Intravenous placebo on Days 1, 29, and 57, followed by subcutaneous placebo on Day 85 and every 4 weeks through Week 48
Experimental: (Stage 2) Brazikumab high dose
Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48
Experimental: (Stage 2) Brazikumab low dose
Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous on Day 85 and every 4 weeks through Week 48
Active_comparator: (Stage 2) Humira®
Administered subcutaneously on Day 1, Day 15, and Day 29 and every 2 weeks through Week 50
Sponsors
Leads: AstraZeneca

This content was sourced from clinicaltrials.gov

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