Deucravacitinib Formulations for Healthy Subjects

No longer recruiting at 1 trial location

Overseen By First line of the email MUST contain the NCT# and Site#

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Bristol-Myers Squibb

Disqualifiers: Liver disease, Organ dysfunction, Severe drug reaction, others

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

Compensation: Varies

Number of Visits: 22

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if two forms of the medication Deucravacitinib are absorbed similarly by the body. Researchers are also examining how food and stomach acidity influence drug levels in the bloodstream. The trial seeks healthy adults with no major health issues or history of severe drug reactions. Participants must fall within a specific body weight and body mass index (BMI) range. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, providing participants the opportunity to be among the first to receive this new medication.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the trial is for healthy subjects, it's likely that participants should not be on any regular medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that deucravacitinib has generally been safe in past studies. One study involving over 5,000 patient-years found that safety remained stable over five years, with no new safety issues identified. Another study found that deucravacitinib was safe for up to two years, with fewer unwanted effects compared to other treatments.

However, some serious infections, such as pneumonia and COVID-19, have been reported in individuals using the drug. It is important not to use deucravacitinib if an active or serious infection is present. Overall, while past research indicates it is generally safe, awareness of potential infections remains crucial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about deucravacitinib because, unlike traditional treatments for autoimmune conditions that often target broad immune responses, deucravacitinib specifically inhibits the TYK2 enzyme. This more targeted approach can potentially reduce inflammation with fewer side effects compared to older drugs like methotrexate or biologics that generally suppress the immune system. Additionally, deucravacitinib is administered orally, offering a more convenient option than injectable treatments, which can greatly improve patient compliance and quality of life. These unique features make deucravacitinib a promising candidate for more effective and patient-friendly management of autoimmune diseases.

What evidence suggests that this trial's treatments could be effective?

Research has shown that deucravacitinib effectively treats moderate to severe plaque psoriasis. Studies have found that it improves symptoms such as itching and skin patches, with patients reporting enhanced well-being. Long-term research confirms its safety and effectiveness for these patients. In studies comparing treatments, deucravacitinib outperformed apremilast, another psoriasis medication. These findings suggest that deucravacitinib could offer significant relief for people with psoriasis. ^{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?

This trial is for healthy adults who can safely take Deucravacitinib, a medication under study. Participants must meet certain health standards but specific inclusion and exclusion criteria are not listed.

Inclusion Criteria

My BMI is between 18 and 32, and I weigh at least 50 kg (110 lb).

Participants must be healthy as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, 12-lead ECGs, and clinical laboratory determinations in the opinion of the investigator

I am willing and able to follow all study requirements.

Exclusion Criteria

Other protocol-defined Inclusion/Exclusion criteria apply

I do not have any serious health issues that could risk my safety in the study.

My organs function properly, and my medical tests are within normal ranges.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single dose of Deucravacitinib in various formulations to assess bioequivalence and the effect of food and pH

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including physical examinations

3 weeks

Up to day 21

What Are the Treatments Tested in This Trial?

Interventions

• Deucravacitinib

Trial Overview The study is testing if small minitablets of Deucravacitinib have the same body response as regular tablets. It also looks at how food and stomach acidity affect the drug's levels in the body.

How Is the Trial Designed?

Group I: BMS-986165 Formulation 2 + Fed Experimental Treatment 1 Intervention

Group II: BMS-986165 Formulation 2 + Famotidine Experimental Treatment 2 Interventions

Group III: BMS-986165 Formulation 2 Experimental Treatment 1 Intervention

Group IV: BMS-986165 Formulation 1 Experimental Treatment 1 Intervention

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 study found that the two formulations of dovitinib (CSF and FMI) had similar systemic exposure, indicating that both can be used interchangeably in patients with advanced solid tumors.

Food intake did not significantly affect the absorption of dovitinib, allowing patients to take the medication with or without meals, which enhances convenience and adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of formulation and food consumption on the bioavailability of dovitinib (TKI258) in patients with advanced solid tumors. Sharma, S., Britten, CD., Mortimer, J., et al.[2014]

The study found that both low C-form and high C-form crystalline versions of lenvatinib capsules showed bioequivalence to the standard reference formulation, indicating similar drug absorption and effectiveness in healthy volunteers (59 subjects).

The safety profile was comparable across all formulations, with treatment-emergent adverse events occurring in 20-24% of participants, although one serious adverse event (spontaneous abortion) was reported in the low C-form group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, three-treatment, three-period, six-sequence-crossover, single-center, bioequivalence study to evaluate the impact of different 10-mg crystalline forms on the pharmacokinetics of lenvatinib in healthy volunteers. Lee, L., D'Angelo, P., Verbel, D., et al.[2015]

The study successfully established a validated Level A in-vitro in-vivo correlation (IVIVC) for the tofacitinib extrudable core system (ECS) osmotic tablet platform, indicating that in vitro dissolution can reliably predict in vivo absorption.

The IVIVC models showed excellent prediction accuracy, meeting FDA criteria with maximum prediction errors of 4.6% for individual data and 3.9% for average data, demonstrating the efficacy of the ECS platform in delivering tofacitinib for rheumatoid arthritis treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and validation of a Level A in-vitro in-vivo correlation for tofacitinib modified-release tablets using extrudable core system osmotic delivery technology. Kushner, J., Lamba, M., Stock, T., et al.[2021]

A modeling and simulation approach confirmed that the dissolution specifications for upadacitinib extended-release tablets are clinically relevant, ensuring consistent therapeutic benefits for patients with rheumatoid arthritis.

Simulated clinical trials showed that both lower and upper dissolution boundary formulations of upadacitinib maintain noninferior efficacy and comparable safety to the target formulation, supporting the quality of the drug released to the market.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of Modeling and Simulation Approach to Support the Clinical Relevance of Dissolution Specifications: a Case Study from Upadacitinib Development. Mohamed, MF., Winzenborg, I., Othman, AA., et al.[2022]

A new dry powder formulation of bevacizumab, a monoclonal antibody for treating non-small cell lung cancer, was successfully created using spray drying, allowing for local delivery to the lungs.

This formulation demonstrated good stability for at least 6 months and maintained its bioactivity, showing efficacy in a rat model at a significantly lower dose (10-fold decrease) compared to traditional intravenous administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local Treatment of Non-small Cell Lung Cancer with a Spray-Dried Bevacizumab Formulation. Shepard, KB., Vodak, DT., Kuehl, PJ., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11333388/

Deucravacitinib Improves Patient-Reported Outcomes in ... Deucravacitinib demonstrated meaningful improvements in patient-reported outcomes in patients with moderate-to-severe plaque psoriasis compared with apremilast ...

2. jamanetwork.com jamanetwork.com/journals/jamadermatology/fullarticle/2827130

Safety and Efficacy of Deucravacitinib in Moderate to ... The results of this analysis further support the long-term safety and efficacy of deucravacitinib for patients with moderate to severe plaque psoriasis.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04908189

NCT04908189 | A Study to Determine the Efficacy and ... The purpose of this study is to evaluate the safety and efficacy of deucravacitinib versus placebo for the treatment of participants with active PsA.

4. academic.oup.com academic.oup.com/bjd/article/190/5/668/7558435

Deucravacitinib in plaque psoriasis: 2-year safety and efficacy ... Deucravacitinib has been shown to improve psoriatic patches and symptoms (such as itching) through 1 year in two global clinical trials in ...

5. drughunter.com drughunter.com/molecule/deucravacitinib

deucravacitinib (BMS-986165) Now in Phase 1/2 trials in healthy volunteers and bronchiectasis patients, CHF6333 was designed to act locally in the lung: high polarity ...

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

SOTYKTU® (deucravacitinib) Safety Profile | for HCPs The most common serious infections reported with SOTYKTU included pneumonia and COVID-19. Avoid use of SOTYKTU in patients with an active or serious infection.

7. 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 ... The safety profile of Sotyktu remained consistent through five years with more than 5,000 patient-years of exposure in the trial, with no new ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10768812/

Deucravacitinib: A Novel TYK2 Inhibitor for the Treatment of ... Treatment with deucravacitinib was well-tolerated through 2 years and had lower rates of AEs compared to 52 weeks of treatment on pooled safety data from POETYK ...

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

SOTYKTU U.S. Prescribing Information Risk Summary. There are no data on the presence of deucravacitinib in human milk, the effects on the breastfed infant, or the effects on milk production.