IM011-127 A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis

Phase 2

Completed

• Conditions: 10018027; inflammation of the large intestine; ulcers of the colon

• Registration Number: NL-OMON51968
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

1.) Type of Participant and Target Disease Characteristics

a. A diagnosis of Ulcerative Colitis (UC) at least (>=) 3 months* duration prior
to screening and source documents must include (i) an endoscopy report, which
shows features consistent with UC, and (ii) a histopathology report showing
features consistent with UC.

If an endoscopy report is not available prior to screening, the screening
endoscopy can be used to confirm the diagnosis. If a histopathology report is
not available prior to screening, endoscopic biopsies can be obtained at the
screening endoscopy (with appropriate consent) and sent to a local
histopathology laboratory for reporting, to meet the criteria described above
prior to randomization.

b. UC disease distribution extending proximal to the rectum (ie, left-sided
colitis or pancolitis)

c. Moderately to severely active UC, defined by a modified Mayo score of 5 to 9
points inclusive, which includes all of the following:
i. A stool frequency (SF) subscore of >= 2, and
ii. A rectal bleeding (RB) subscore >= 1, and
iii. An endoscopic (ES) subscore of >= 2

d. Must be up to date with surveillance for dysplasia and screening for
colorectal neoplasia, according to local standard of care

2.) Age and Reproductive Status

a. Males and Females, ages 18 (or local age of majority) to 65 years,
inclusive, at the time of screening.

b. Women who are not of child-bearing potential are exempt from contraception
requirements. Female subjects must have documented proof that they are not of
childbearing potential

c. Women of Child Bearing Potential (WOCBP) must have a negative highly
sensitive serum or urine pregnancy test.
(minimum sensitivity 25 IU/L or equivalent units of human chorionic
gonadotropin) within 24 hours prior to the start of study treatment. If a urine
test cannot be confirmed as negative (eg, an ambiguous result), a serum
pregnancy test is required. The participant must be excluded from participation
if the serum pregnancy result is positive.

d. A female subject is eligible to participate if she is not pregnant or
breastfeeding and at least one of the following conditions applies:
(1) Is not a WOCBP
OR
(2) a WOCBP and using a contraceptive method(s) as described in the protocol
during the intervention period (at a minimum until after the last dose of study
intervention)

e. Males who are sexually active with WOCBP must agree to follow instructions
for contraception as desribed in the protocol

f. Azoospermic males are exempt from contraceptive requirements

3. ) Prior UC Medication Failure Inclusion Criteria

a. Documentation of an inadequate response, loss of response, or intolerance to
a treatment course of 1 or more of the following standard of care medications:

i. Oral 5-aminosalicylic acids (5-ASAs) (eg, mesalamine, sulfasalazine,
olsalazine, or balsalazide)

ii. Corticosteroids (eg, prednisone or budesonide MMX)

iii. Immunomodulators (eg, azathioprine [AZA], 6-mercaptopurine [6-MP], or
methotrexate [MTX]

iv. Anti-TNF agents (eg, infliximab, adalimumab, or golimumab)

v. Integrin inhibitors (eg, vedolizumab)

vi. Anti-IL-12/IL-23p40 antibodies (eg, ustekinumab): subjects can only be
included if they were intolerant to tre

Exclusion Criteria

1.) Medical Conditions

a. Women who are pregnant or breastfeeding

2.) Ulcerative Colitis (UC) Exclusion Criteria

a. UC involving the rectum only (UC proctitis).

b. Current diagnosis of Crohn*s disease, indeterminate colitis, ischemic
colitis or microscopic.

c. Current or recent (within 12 weeks prior to randomization) evidence of
fulminant UC (also known as acute severe UC) or toxic megacolon.
d. Current or recent (within 12 weeks prior to randomization) evidence of
bowel perforation or intra-abdominal abscess.

e. Current or recent colonic diverticulitis. Subject must be adequately
treated and off antibiotics for diverticulitis for 60 days prior to
randomization.

f. Current colonic adenomas or mucosal dysplasia

i. A subject with adenomatous polyps may be eligible if the polyps have been
completely removed or eradicated (documented). The subject must be free of
polyps at randomization.

ii. A subject with mucosal dysplasia may be eligible if the dysplasia has been
completely removed/resected/eradicated (as applicable, documented), and the
subject is free of dysplasia at randomization. This should be discussed with
the BMS Medical Monitor/designee prior to screening

iii. Subjects with a history of UC greater than (>) 8 years* duration (who have
not had a colonoscopy in the prior 12 months) must have a full colonoscopy at
screening.

Subjects who require a colonoscopy to screen for dysplasia (based on local
guidelines) must have a full colonoscopy at screening

Subjects who require a colonoscopy to screen for colorectal cancer (based on
local guidelines) must have a full colonoscopy at screening.

3.) Gastrointestinal (GI) Surgery Exclusion Criteria

a. History or evidence of extensive colonic resection, subtotal or total
colectomy, with or without a stoma or pouch.

b. Current need for, or anticipated need for, surgical intervention for UC
during the study.

c. GI surgery within 3 months prior to randomization Subject must have adequate
wound healing prior to randomization.

4.) Additional Gastrointestinal (GI) Exclusion Criteria

a. Current or recent (within 12 weeks prior to randomization) GI disease that
may confound efficacy assessment or any GI disease associated with poor
absorption of the investigational product (for example, untreated celiac sprue,
bile salt-mediated diarrhoea, or short bowel syndrome).

b. Receiving enteral feeding, defined formula diets, or total parenteral
alimentation.

5.) Immune and Infectious Disease Exclusion Criteria

a. History of congenital or acquired immunodeficiency

b. Known serious infection, defined as any infection requiring hospitalization
or treatment with parenteral (intramuscular [IM] or IV) antimicrobial agents
(eg, antibiotics, antiviral, antifungal, or antiparasitic agents) within 30
days of the first dose of study treatment. Completion of oral antimicrobial
agents within 2 weeks of the first dose of study treatment.

Antibiotics used to cover a procedure such as endoscopy would not exclude the
subject.

c. Current or recent (within 12 weeks prior to randomization) herpes zoster,
herpes simplex, or influenza infection

d. History of disseminated or complicated herpes zoster infect

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of the study is to estimate the efficacy of BMS-986165 at<br /><br>Week 12<br /><br><br /><br>This will measured by the proportion of subjects in clinical response at Week<br /><br>12</p><br>