Inflammatory Bowel Disease (IBD)
Conditions
Interventions
Patients who have completed screening procedures (up to 28 days duration) and
meet inclusion/exclusion criteria will be randomized on Day 1 of the treatment
period.
All participants will receive de
blood, stool and urine collection for
checking safety, pharmacokinetics, and biomarkers, vital signs monitoring,
endoscopy with biopsies, ECG, additional efficacy assessments, questionnaires
and pa
Sponsors
Bristol-Myers Squibb
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Signed Written Informed Consent a) Participants must be willing to participate in Study IM011077 and must have the ability to sign the informed consent form. b) Willing and able to complete all study specific procedures and visits. 2) Type of Participant and Target Disease Characteristics a) Previously completed OLE treatment in 1 of the parent CD or UC studies; b) Be in clinical response or clinical remission at Week 104 of Study IM011023 or Study IM011024, or Week 52 of Study IM011127; • Evidence of clinical response or clinical remission (compared with baseline in the parent study) as defined by CDAI or modified Mayo score; AND • No worsening of endoscopy (by SES-CD or Mayo endoscopic subscore) from the parent study baseline (as assessed by local read). 3) Age and Reproductive Status Investigators shall counsel women of childbearing potential (WOCBP) participants, and male participants who are sexually active with WOCBP, on the importance of pregnancy prevention and the implications of an unexpected pregnancy. • The investigator shall evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. • Local laws and regulations may require the use of alternative and/or additional contraception methods. a) Female Participants • Females, age 18 or local age of majority and older at the time of enrollment. • Women who are not of childbearing potential are exempt from contraceptive requirements. • Women participants must have documented proof that they are not of childbearing potential. • WOCBP must have a negative highly sensitive 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. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. • The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. • WOCBP must agree to follow instructions for method(s) of contraception as described below and included in the ICF. • WOCBP are permitted to use hormonal contraception methods as described. • A female participant 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) Is a WOCBP and using a contraceptive method(s), during the treatment period (at a minimum until after the last dose of study treatment). b) Male Participants • Males, age 18 or local age of majority and older at the time of enrollment. • Male participants should maintain their usual practice with regard to contraception (if any); however, no specific contraceptive measures are required.
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1) Medical Conditions a) Women who are pregnant or breastfeeding. 2) Gastrointestinal Exclusion Criteria a) Current colonic adenomas or dysplasia diagnosed at the endoscopy performed at the end of treatment visit of the parent study or past confirmed colonic dysplasia in the parent study that has not been eradicated. A participant with adenomatous polyps may be eligible if the polyps have been completely removed (documented) and the participant is free of polyps at enrollment (Day 1). A participant with mucosal dysplasia may be eligible if the dysplasia has been completely removed/resected/eradicated (as applicable, documented), and the participant is free of dysplasia at enrollment (Day 1). This should be discussed with the BMS Medical Monitor/designee prior to enrollment. Participants must be current with surveillance for dysplasia and screening for colorectal cancer (based on local guidelines). 3) Immune and Infectious Disease Exclusion Criteria a) 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. Antibiotics used to cover a procedure such as endoscopy would not exclude the participant. Prophylactic antibiotic use should be discussed with the BMS Medical Monitor/designee. Additionally, in the case of prior SARS-CoV-2 infection, symptoms must have resolved and, based on investigator assessment in consultation with the BMS Medical Monitor/designee, there are no sequelae that would place the participant at a higher risk by receiving investigational treatment. 4) Prior/Concomitant Therapy a) Have received any of the following therapies since the first dose of study treatment in the parent study or before Day 1 in Study IM011077: i) Treatment with an immunomodulatory or biologic agent for the treatment of IBD. ii) Treatment with an investigational agent other than deucravacitinib. iii) Treatment with D-penicillamine, leflunomide, thalidomide, S1P inhibitors (eg, ozanimod, fingolimod, and etrasimod), or JAK inhibitors (eg, tofacitinib, upadacitinib, and filgotinib). b) Are currently receiving or require initiation of any of the following therapies: i) Treatment with corticosteroids at a dose that exceeds the prednisone equivalent of 7.5 mg/day for adrenal insufficiency. ii) Treatment with immunomodulatory agents (eg, azathioprine, 6-mercaptopurine, or methotrexate). c) Treatment with a live vaccine or live attenuated vaccine within 90 days prior to Visit 1 of this trial. d) Prophylactic antibiotic use should be discussed with the BMS Medical Monitor/designee. 5) Physical and Laboratory Test Findings a) Evidence of active or latent tuberculosis Participants diagnosed with latent TB infection (LTBI) in the parent study are eligible to continue in this study if (1) there are no current signs or symptoms of active TB, (2) the participant has received adequate documented treatment for LTBI within 5 years of screening in the parent study. b) Evidence of active hepatitis B virus (HBV) infection as defined. Participants who were required to have HBV deoxyribonucleic acid (DNA) tested every 3 months in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study will be to assess the safety and tolerability of long-term use of deucravacitinib in participants with moderate to severe CD. This will be measured by collecting the number and proportion of participants experiencing Adverse Events (AEs), Serious AEs (SAEs), AEs leading to study discontinuation and AEs of Interest (AEIs). The number and proportion of participants experiencing abnormalities in the laboratory testing, ECG and vital sign parameters over time. Changes from Day 1 for laboratory testing, ECG and vital signs will also be measured. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives of the study are as follows: • To assess the effect of long-term use of deucravacitinib in participants with moderate to severe UC and CD This will be measured by a number of factors including the proportion of participants with clinical remission, clinical response, endoscopic response, endoscopic remission, histologic remission, mucosal healing. • To assess the effect of long-term use of deucravacitinib on health-related quality of life This will be measured by a number of factors including the Inflammatory Bowel Disease (IBD) Questionnaire, Stool Frequency (SF) questionnaire and bowel urgency response. • To obtain data regarding the effect of long-term use of deucravacitinib on healthcare utilisation This will be measured by the proportion of participants with IBD-related hospitalisation and IBD-related surgery • To obtain data regarding the effect of long-term use of deucravacitinib on PK. This will be measured from plasma sample concentrations of deucravacitinib over the course of the study • To obtain data regarding the effect of long-term use of deucravacitinib on biomarkers. This will be measured by the change from baseline in faecal calprotectin and faecal lactoferrin over time, in addition to the change from baseline of inflammatory biomarkers over time in circulation and tissues • To assess the impact of SARS-CoV-2 serologic status on participants receiving deucravacitinib. This will be measured by checking the levels of SARS-CoV-2 in the blood over the course of the study. | — |
Countries
Netherlands
Outcome results
None listed