Deucravacitinib for Inflammatory Bowel Disease

No longer recruiting at 92 trial locations

Overseen By BMS Study Connect Contact Center www.BMSStudyConnect.com

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Bristol-Myers Squibb

Disqualifiers: Pregnancy, Breastfeeding, Colonic adenomas, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the long-term safety and effectiveness of the drug Deucravacitinib (also known as Sotyktu or BMS-986165) for individuals with moderate to severe Crohn's disease or ulcerative colitis. It targets participants who have already taken part in a previous Deucravacitinib trial for these conditions. Those who completed an earlier study with this drug and have either Crohn's disease or ulcerative colitis might be suitable candidates for this trial. The researchers aim to determine if this treatment remains safe and effective in managing symptoms. As a Phase 2 trial, the research focuses on assessing the treatment's efficacy in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that Deucravacitinib is likely to be safe for humans?

Research has shown that Deucravacitinib is generally well-tolerated over long periods. In studies involving patients with moderate to severe plaque psoriasis, the safety of Deucravacitinib remained consistent for up to five years. With over 5,000 patient-years of use, researchers found no new safety concerns. Common side effects, experienced by at least 1% of participants, included headaches and upper respiratory tract infections. These findings suggest that Deucravacitinib is generally safe for long-term use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Crohn's disease and Ulcerative Colitis?

Deucravacitinib is unique because it targets a different part of the immune system compared to standard treatments. Most current therapies for Crohn's Disease and Ulcerative Colitis, like TNF inhibitors, focus on blocking specific proteins that promote inflammation. Deucravacitinib, however, works by selectively inhibiting the TYK2 enzyme, which is a key player in the pathway that leads to inflammation. This targeted approach could offer a more precise treatment, potentially reducing side effects and improving long-term outcomes for patients. Researchers are excited because this innovative mechanism might help those who haven't responded well to existing therapies.

What evidence suggests that Deucravacitinib might be an effective treatment for Crohn's disease or Ulcerative Colitis?

Research has shown that Deucravacitinib holds promise for treating conditions like plaque psoriasis. In studies, patients using Deucravacitinib experienced consistent safety and effectiveness over several years. Many patients saw a clear improvement in their skin condition, which remained stable over time. Although primarily studied for skin issues, the drug targets specific parts of the immune system, which might also benefit digestive conditions like Crohn's disease and ulcerative colitis. Early results in these areas are still emerging, but the potential is based on its success with other inflammatory conditions. Participants in this trial will receive Deucravacitinib as part of the long-term extension rollover study. ^{4 6 7 8 9}

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

Inclusion Criteria

You have already participated in an open-label extension study for Crohn's disease or ulcerative colitis.

Exclusion Criteria

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

Women who are pregnant or breastfeeding

There are other requirements and restrictions that apply to participate in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Long-Term Extension

Participants continue to receive Deucravacitinib to evaluate long-term safety and efficacy

Up to 110 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Deucravacitinib

How Is the Trial Designed?

Group I: Long-Term Extension Rollover Study: Deucravacitinib Experimental Treatment 1 Intervention

Deucravacitinib is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Sotyktu for:

• Moderate to severe plaque psoriasis

Approved in European Union as Sotyktu for:

• Moderate to severe plaque psoriasis

Approved in Canada as Sotyktu for:

• Moderate to severe plaque psoriasis

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Published Research Related to This Trial

The ACCEPT trial is investigating the safety and efficacy of adding acalabrutinib, a second-generation Btk inhibitor, to the standard R-CHOP regimen in patients with untreated Diffuse Large B-cell Lymphoma (DLBCL), with a focus on establishing the recommended dose and assessing overall response rates.

This open-label trial includes up to 39 participants and aims to provide preliminary evidence on the combination's effectiveness and safety, potentially paving the way for larger Phase II/III trials in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ACCEPT - combining acalabrutinib with rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone (R-CHOP) for Diffuse Large B-cell Lymphoma (DLBCL): study protocol for a Phase Ib/II open-label non-randomised clinical trial. Davies, A., Barrans, S., Burton, C., et al.[2021]

A review of seven targeted cancer therapies (sunitinib, pazopanib, bevacizumab, temsirolimus, axitinib, everolimus, and sorafenib) revealed that all these medications are associated with adverse events, highlighting the importance of monitoring patients closely.

Effective management strategies for these side effects can prevent them from becoming severe, which is crucial to maintaining the full efficacy of the treatments and avoiding unnecessary dose reductions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A contemporary update on rates and management of toxicities of targeted therapies for metastatic renal cell carcinoma. Alasker, A., Meskawi, M., Sun, M., et al.[2022]

Sunitinib has a similar safety profile in patients undergoing nephrectomy for kidney cancer, whether used in the adjuvant setting or for metastatic disease, based on data from phase III trials including CARMENA and SURTIME.

Effective management of sunitinib's adverse effects is crucial, particularly in the adjuvant setting, where maintaining dose intensity and exposure can impact treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of sunitinib in patients with renal cell carcinoma following nephrectomy. Heraudet, L., Domblides, C., Daste, A., et al.[2022]

A total of 3120 adverse event cases related to avapritinib were reported to the FDA, with 44% occurring within the first 30 days of treatment, highlighting the importance of monitoring patients closely during this period.

The study found that elderly male patients are at a higher risk for serious adverse events, indicating that clinicians should exercise caution when prescribing avapritinib to this demographic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A post-marketing pharmacovigilance study of avapritinib: Adverse event data mining and analysis based on the United States Food and Drug Administration Adverse Event Reporting System database. Rong, L., Xie, M., Jiang, M., et al.[2023]

Citations

1. news.bms.com news.bms.com/news/details/2025/Bristol-Myers-Squibb-Presents-Two-Late-Breaking-Presentations-Demonstrating-Sotyktu-deucravacitinib-Efficacy-in-Psoriatic-Arthritis-and-Systemic-Lupus-Erythematosus/default.aspx

Corporate news details Further, a higher proportion of patients saw no progression of joint damage with Sotyktu treatment compared with placebo at Week 16 (Sotyktu, ...

2. sotyktuhcp.com sotyktuhcp.com/efficacy/long-term-extension-data

SOTYKTU® (deucravacitinib) Long-Term Extension Data Deucravacitinib in moderate to severe plaque psoriasis: 5-year, long-term safety and efficacy results from the phase 3 POETYK PSO-1, PSO-2, and LTE trials.

3. news.bms.com news.bms.com/news/details/2025/New-Five-Year-Sotyktu-deucravacitinib-Data-Show-Consistent-Safety-and-Durable-Response-Rates-in-Moderate-to-Severe-Plaque-Psoriasis/default.aspx

New Five-Year Sotyktu (deucravacitinib) Data Show ... Clinical efficacy outcomes were sustained in patients who were continuously treated with Sotyktu for PASI 75 (72.1%, Year 1; 67.3%, Year 5), ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04036435

NCT04036435 | Long-Term Study That Measures the ... The main purpose of this study is to characterize the long-term safety and efficacy of the drug Deucravacitinib (BMS-986165) in patients who have been ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40045918/?utm_source=FeedFetcher&utm_medium=rss&utm_campaign=None&utm_content=1l1vNBYu_ed6RIBx4yjiYJ-tnJX2DEnfLu2bT3RUcVLTGoG9AU&fc=None&ff=20250329043238&v=2.18.0.post9+e462414

Deucravacitinib in plaque psoriasis: Four-year safety and ... Deucravacitinib demonstrated a consistent safety profile and durable efficacy through 4 years of treatment in patients with moderate to severe plaque psoriasis.

6. sotyktuhcp.com sotyktuhcp.com/safety-profile

SOTYKTU® (deucravacitinib) Safety Profile | for HCPs No new safety signals observed through Year 5 ; Data cutoff date of September 2, 2024. 79.4% of patients had total SOTYKTU exposure for ≥12 months and 29.6% for ...

7. packageinserts.bms.com packageinserts.bms.com/pi/pi_sotyktu.pdf

SOTYKTU U.S. Prescribing Information The efficacy and safety of SOTYKTU 6 mg once daily were assessed in two multicenter, randomized, double-blind, placebo- and active-controlled clinical trials, ...

8. sotyktu.com sotyktu.com/about-sotyktu/safety-and-side-effects

Safety & Common SOTYKTU® Side Effects Below are the side effects experienced by at least 1% of people who took SOTYKTU in clinical trials, out of a total of 1684 participants.

9. sotyktuhcp.com sotyktuhcp.com/

SOTYKTU® (deucravacitinib) for Moderate-to-Severe Plaque ... Deucravacitinib in moderate to severe plaque psoriasis: 5-year, long-term safety and efficacy results from the phase 3 POETYK PSO-1, PSO-2, and LTE trials.