Deucravacitinib for Psoriasis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how deucravacitinib, a psoriasis medication, affects pregnancy and babies. Researchers aim to determine its impact on pregnancy outcomes for women with psoriasis who take this medication. The study includes different groups: those taking deucravacitinib or other medications for varying durations, and some taking no medication. Women with psoriasis who have managed the condition for at least a year and are currently pregnant might be suitable candidates for this trial. As a Phase 4 trial, this research seeks to understand how the FDA-approved treatment benefits more patients, providing valuable insights for expectant mothers with psoriasis.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot be exposed to any known teratogens (substances that can cause birth defects) from a certain time before conception through the exposure window.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that deucravacitinib has been tested for safety in people with moderate to severe plaque psoriasis over four years. The results indicate that it is generally well-tolerated, with most side effects being mild to moderate, such as headaches or mild digestive issues. However, specific information on its safety during pregnancy is not yet available.
While studies on animals have been conducted, studies on pregnant humans to determine if deucravacitinib causes birth defects have not been done. Consequently, a pregnancy exposure registry is in place to gather more information on its safety for pregnant women. This registry tracks the outcomes of pregnancies where the mother took the medication.
Anyone considering joining the trial should discuss any concerns with their healthcare provider, especially if they are pregnant or planning to become pregnant.12345Why are researchers excited about this trial?
Unlike the standard of care for psoriasis, which typically involves topical treatments, phototherapy, or systemic medications like methotrexate and biologics, deucravacitinib offers a unique approach. This drug is a selective TYK2 inhibitor, working by selectively targeting the tyrosine kinase 2 (TYK2) enzyme, which plays a crucial role in the inflammatory process. Researchers are excited about deucravacitinib because it has the potential to provide effective treatment with potentially fewer side effects compared to broader immune suppressants. This targeted mechanism means it might offer a new option for patients who struggle with or do not respond well to existing treatments.
What evidence suggests that this trial's treatments could be effective for pregnancy and infant outcomes in women with psoriasis?
Research shows that deucravacitinib is an approved treatment for psoriasis, a skin condition that causes red, itchy, and scaly patches. This medication targets a specific part of the immune system, reducing inflammation and slowing the rapid growth of skin cells. Although it is effective for psoriasis, limited information exists on its use during pregnancy. In this trial, participants will be divided into different cohorts to assess the safety of deucravacitinib during various pregnancy stages. Some cohorts will receive deucravacitinib for the full pregnancy duration, while others will receive it only during the first trimester or the first 20 weeks of gestation. Additionally, other cohorts will be exposed to different systemic psoriasis medications or no systemic medications at all. The study aims to gather data to better understand the potential risks and safety of deucravacitinib and other treatments during pregnancy.35678
Who Is on the Research Team?
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Observation
Participants are observed for pregnancy outcomes while exposed to deucravacitinib or other systemic medications
Follow-up
Participants' infants are monitored for major congenital malformations and other infant outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Deucravacitinib
How Is the Trial Designed?
9
Treatment groups
Experimental Treatment
Participants not exposed to any systemic medications during the first 20 weeks of gestation
Participants not exposed to any systemic medications during the first trimester
Participants not exposed to any systemic medications for the full pregnancy duration
Participants exposed to other systemic psoriasis medications for the first 20 weeks of gestation
Participants exposed to other systemic psoriasis medications for the first trimester
Participants exposed to other systemic psoriasis medications for the full pregnancy duration
Participants exposed to deucravacitinib for the first 20 weeks of gestation
Participants exposed to deucravacitinib for the first trimester
Participants exposed to deucravacitinib for the full pregnancy duration
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bristol-Myers Squibb
Lead Sponsor
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
Citations
Deucravacitinib - StatPearls - NCBI Bookshelf - NIH
Pregnancy considerations: The data available from the case studies on deucravacitinib use during pregnancy are not adequate to assess the drug- ...
2.
theglobeandmail.com
theglobeandmail.com/investing/markets/stocks/BMY/pressreleases/35737161/bristol-myers-squibbs-deucravacitinib-study-assessing-safety-in-pregnancy/Bristol-Myers Squibb's Deucravacitinib Study: Assessing ...
The study aims to assess the safety of deucravacitinib, a drug used to treat psoriasis, during pregnancy by observing outcomes in pregnant ...
3.
ctv.veeva.com
ctv.veeva.com/study/a-study-on-the-safety-of-deucravacitinib-exposure-in-pregnant-women-and-their-offspringA Study on the Safety of Deucravacitinib Exposure in Pregnant ...
This observational study aims to assess pregnancy and infant outcomes among pregnant women with psoriasis who have been exposed to deucravacitinib treatment in ...
214958Orig1s000 OTHER REVIEW(S) - accessdata.fda.gov
... birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are no data on chronic use of deucravacitinib during pregnancy.
Deucravacitinib (Sotyktu®)
Human pregnancy studies have not been done to see if deucravacitinib can increase the chance of birth defects. Experimental animal studies done ...
SOTYKTU® (deucravacitinib) Patient Resources | for HCPs
A pregnancy exposure registry is available for patients who take SOTYKTU during pregnancy. The registry collects valuable information about pregnancy and ...
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.
Deucravacitinib in plaque psoriasis: Four‐year safety and ...
Safety and efficacy data were assessed through 1 November 2023 (cumulative Week 208 [4 years]). Safety data are reported in the as‐treated population ...
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