A phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn's Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy

Phase 3

• Conditions: Crohn's Disease; 10017969

• Registration Number: NL-OMON30746
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 16

Inclusion Criteria

1) Subject is willing to participate in the study and has signed the informed consent
2) Subject must have had CD for at least 3 months from the time of initial diagnosis. Active CD must be confirmed by radiologic, endoscopic or histologic evidence within the previous 12 months. If previous confirmation of diagnosis is not available or if previous diagnosis is not deemed conclusive at time of screening, CD diagnosis should be confirmed by endoscopy, radiology or histology.
3) Subjects must satisfy at least one of the following criteria:
a) Having had an inadequate response to at least 1 of the following treatments (subjects may be currently receiving 1 of these medications or have received them previously):
i) oral aminosalicylates (e.g., mesalamine, sulfasalazine, olsalazine, balsalizide) at or above the approved label dose for at least 8 weeks and/or
ii) oral prednisone >= 30 mg/day (or equivalent) or budesonide >= 9 mg/day for at least 4 weeks and/or
iii) immunosuppressants (azathioprine >= 2 mg/kg/day or 6-mercaptopurine >= 1.0 mg/kg/day [or documentation of a therapeutic concentration of 6 thioguanine nucleotide] or methotrexate >= 15 mg/week) for at least 12 weeks and/or
iv) an approved anti-TNF agent at an approved labeled dose for at least 8 weeks
AND/OR
b) Have been intolerant to one of the above mentioned treatments (e.g., unable to achieve doses or treatment durations because of dose limiting side effects [e.g., leukopenia]).
4) Moderate to severe CD as measured by a CDAI score >= 220 and <= 450
5) hsCRP > Upper Limit of Normal (ULN)
6)Men and women, ages >=18

Exclusion Criteria

1) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 10 weeks after the study
2) WOCBP using a prohibited contraceptive method (there are no prohibited methods for this study)
3) Women who are pregnant or breastfeeding
4) Women with a positive pregnancy test on enrollment or prior to study drug administration
5) Diagnosis of Ulcerative or Indeterminate Colitis
6) CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement
7) Suspected or diagnosed intra-abdominal or perianal abscess at screening
8) Known strictures or stenosis leading to symptoms or obstruction
9) Current evidence of fulminant colitis, toxic megacolon or bowel perforation
10) Subjects who are scheduled or anticipate the need for surgery, aside from dermatologic procedures
11) Subjects who have a history of clinically significant drug or alcohol abuse
12) Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, pulmonary, cardiac, neurological, ophthalmologic or cerebral disease. Concomitant medical conditions that in the opinion of the Investigator might place the subject at unacceptable risk for participation in this study
13) Subjects with a history of cancer within the last 5 years (other than non-melanoma skin cell cancers cured by local resection). Existing non-melanoma skin cell cancers must be removed prior to enrollment. Subjects with carcinoma in situ, treated with definitive surgical intervention, are allowed
14) Subjects at risk for tuberculosis (TB).
15) Subjects with any serious bacterial infection within the last 3 months, unless treated and resolved with antibiotics, or any chronic bacterial infection (such as chronic pyelonephritis, osteomyelitis and bronchiectasis)
16) Female subjects who have had a breast cancer screening that is suspicious for malignancy, and in whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory or other diagnostic evaluations
17) A history of severe or anaphylactic infusion reaction after receiving a biologic agent, suspected to be associated with an immune response

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Placebo-controlled Induction Period:<br /><br>Compare the proportion of subjects who have a clinical response (as defined by<br /><br>a reduction in Crohn*s Disease Activity Index (CDAI) >= 100 or an absolute CDAI<br /><br>score < 150) at both Day IP-57 (Week 8) and Day IP-85 (Week 12) between the<br /><br>abatacept and placebo treatment regimens.<br /><br><br /><br>Maintenance Period:<br /><br>Compare the proportion of subjects who are in clinical remission (as defined by<br /><br>a CDAI < 150) at Day MP-365 (12 months) between the abatacept and placebo<br /><br>treatment regimens.<br /><br><br /><br>Open-Label Extension Phase:<br /><br>Assess the long-term clinical safety and tolerability of abatacept treatment<br /><br>during the Open-label Extension Phase.</p><br>