Deucravacitinib for Nail Psoriasis

Overseen By Ralee' Bunt, MSPH

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Alabama at Birmingham

Must not be taking: Strong CYP450 inducers

Disqualifiers: Uncontrolled major diseases, Psychiatric history, Substance abuse, others

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests deucravacitinib, a new treatment for nail psoriasis, to evaluate its effectiveness and safety. Nail psoriasis causes changes and discomfort in the nails, often accompanying skin psoriasis. Participants will take a daily dose of the medication for 48 weeks. Ideal candidates are adults with nail psoriasis who require strong medication for skin disease and have experienced psoriasis for at least six months. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

Yes, you will need to stop taking certain medications. You must discontinue all systemic therapies for psoriasis or psoriatic arthritis at least 4 weeks before the trial, and biologics at least 2 months before. Topical therapies must be stopped 2 weeks prior, and UV therapy 2 weeks prior, with PUVA therapy stopped 4 weeks prior.

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

Research has shown that deucravacitinib has been tested for safety in conditions like psoriasis and psoriatic arthritis. In a study examining its use over four years, deucravacitinib proved safe, with most side effects being mild to moderate. Common side effects included colds and headaches. Another study on psoriatic arthritis demonstrated similar safety results after one year.

Deucravacitinib is already approved for other conditions, suggesting it is generally well-tolerated. However, since this trial is in the early stages, limited information exists specifically about its use for nail psoriasis. Joining the trial will help gather more safety information for this condition. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for nail psoriasis, which often include topical corticosteroids and systemic therapies like methotrexate, deucravacitinib offers a novel approach. This treatment is unique because it targets the TYK2 enzyme, a key player in the inflammatory process behind psoriasis, with more precision. Researchers are excited about deucravacitinib because its selective mechanism could potentially offer better efficacy with fewer side effects compared to current options. Plus, its oral administration makes it more convenient than many existing treatments that require injections or topical application.

What evidence suggests that deucravacitinib might be an effective treatment for nail psoriasis?

Research has shown that deucravacitinib effectively treats various types of psoriasis, including nail psoriasis. It works well on the palms, soles, and fingernails, regardless of severity. Patients with plaque psoriasis have experienced positive results over four years, indicating long-term benefits. The drug also aids in managing related conditions like psoriatic arthritis. These findings suggest that deucravacitinib can effectively treat nail psoriasis. ^{2 4 5 6 7}

Are You a Good Fit for This Trial?

Adults over 18 with chronic plaque psoriasis and nail psoriasis, who are in good health aside from their skin condition. Participants must not have used systemic therapies for psoriasis or biologics within specific time frames before the study starts and be willing to have photos taken of their nails.

Inclusion Criteria

I stopped all psoriasis treatments at least 4 weeks ago, or 2 months for biologics.

I am in good health except for psoriasis or mild kidney issues.

Give written informed consent prior to any study procedures being conducted, and authorize the release and use of protected health information (PHI)

Exclusion Criteria

I have been treated with deucravacitinib before.

Other than disease under study, any clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is currently uncontrolled

Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 6 mg of deucravacitinib daily for the treatment of nail psoriasis

48 weeks

Regular assessments including mNAPSI and photographic documentation

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Deucravacitinib

Trial Overview The trial is testing Deucravacitinib, an oral medication, given at a dose of 6 mg daily to treat nail psoriasis. The study will follow twenty patients for 48 weeks, using assessments like the modified Nail Psoriasis Severity Index and photographs to track changes.

How Is the Trial Designed?

Group I: Deucravacitinib 6 mg Daily Experimental Treatment 1 Intervention

All participants will receive 6 mg of deucravacitinib daily.

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?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

A case study showed that a patient with nail psoriasis experienced significant improvement after taking upadacitinib, a selective JAK1 inhibitor, at a dose of 15mg daily for 5 months.

The therapeutic effects of upadacitinib may be linked to its ability to target inflammatory cytokines like IL-6, IL-10, and IL-23, suggesting it could be an effective treatment option for severe nail psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upadacitinib in nail psoriasis: a case report. Wang, N., Yang, Q., Liu, Y., et al.[2023]

In a study involving 404 patients with moderate-to-severe plaque psoriasis, guselkumab treatment led to significant improvements in nail psoriasis, with better outcomes associated with lower baseline severity and higher skin efficacy at week 16.

After stopping guselkumab treatment, patients maintained their nail psoriasis improvements longer than their skin improvements, suggesting that guselkumab may provide lasting benefits for nail health even after treatment withdrawal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nail psoriasis dynamics during biologic treatment and withdrawal in patients with psoriasis who may be at high risk of developing psoriatic arthritis: a post hoc analysis of the VOYAGE 2 randomized trial. Tillett, W., Egeberg, A., Sonkoly, E., et al.[2023]

A consensus group of international dermatologists developed practical treatment recommendations for nail psoriasis, particularly for patients with mild skin lesions or no skin psoriasis, emphasizing tailored approaches based on the severity and type of nail involvement.

For limited nail psoriasis affecting three or fewer nails, intralesional steroid injections are recommended for cases with matrix involvement, while topical steroids and vitamin D analogues are suggested for nail bed involvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommendations for the definition, evaluation, and treatment of nail psoriasis in adult patients with no or mild skin psoriasis: A dermatologist and nail expert group consensus. Rigopoulos, D., Baran, R., Chiheb, S., et al.[2019]

Deucravacitinib is a first-in-class oral TYK2 inhibitor that works by stabilizing an inhibitory interaction within the TYK2 enzyme, which is important for treating various immune-mediated diseases.

It received its first approval in the USA on September 9, 2022, for adults with moderate-to-severe plaque psoriasis, and has since been approved in Japan for multiple forms of psoriasis, indicating its efficacy and safety in managing these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deucravacitinib: First Approval. Hoy, SM.[2022]

Deucravacitinib, an oral medication for moderate to severe plaque psoriasis, demonstrated higher PASI 75 response rates compared to apremilast and methotrexate across all time points in a network meta-analysis of 47 randomized controlled trials.

Long-term efficacy of deucravacitinib was comparable to first-generation biologics like adalimumab and ustekinumab, making it a viable oral treatment option for patients seeking effective psoriasis management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-, Mid-, and Long-Term Efficacy of Deucravacitinib Versus Biologics and Nonbiologics for Plaque Psoriasis: A Network Meta-Analysis. Armstrong, AW., Warren, RB., Zhong, Y., et al.[2023]

Deucravacitinib is an oral small molecule that specifically inhibits TYK2, showing promising safety and efficacy for treating moderate to severe plaque psoriasis.

In phase III clinical trials, over 50% of patients taking deucravacitinib 6 mg daily achieved a significant reduction in psoriasis severity (≥75% improvement) at 16 weeks, compared to only 9-13% on placebo and 35-41% on another treatment, apremilast.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deucravacitinib in moderate-to-severe psoriasis. Vu, A., Maloney, V., Gordon, KB.[2022]

Deucravacitinib, an oral TYK2 inhibitor, demonstrated significant efficacy in treating moderate to severe plaque psoriasis, with 65.1% of patients achieving a PASI 75 response at week 16 across 6 clinical trials involving 2248 subjects.

The safety profile of deucravacitinib is favorable, with mild adverse events like nasopharyngitis being common, and serious adverse events occurring in only 1.35% to 9.5% of patients, making it a potentially less burdensome treatment option compared to injectable therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deucravacitinib: The First FDA-Approved Oral TYK2 Inhibitor for Moderate to Severe Plaque Psoriasis. Truong, TM., Pathak, GN., Singal, A., et al.[2023]

Tofacitinib, a new treatment for rheumatoid arthritis, shows promise in improving nail dystrophy in patients who have not responded to traditional therapies.

Nail dystrophy can be linked to autoimmune conditions like psoriasis and psoriatic arthritis, suggesting that tofacitinib may address underlying autoimmune mechanisms in these cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recovery of nail dystrophy potential new therapeutic indication of tofacitinib. Jaller, JA., Jaller, JJ., Jaller, AM., et al.[2018]

In a pilot study of 13 patients with SAPHO syndrome, tofacitinib significantly improved nail lesions and palmoplantar psoriasis after 12 weeks, with a median reduction of 67% in Nail Psoriasis Severity Index scores and 71% in Palmoplantar Psoriasis Area and Severity Index scores.

Tofacitinib also enhanced the quality of life for patients, as indicated by a significant improvement in Dermatology Life Quality Index scores, and showed a decrease in inflammatory markers, with no severe adverse events reported during the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tofacitinib for the Treatment of Nail Lesions and Palmoplantar Pustulosis in Synovitis, Acne, Pustulosis, Hyperostosis, and Osteitis Syndrome. Li, C., Li, Z., Cao, Y., et al.[2021]

Deucravacitinib, a selective tyrosine kinase 2 inhibitor, was found to be safe and well tolerated in a study involving 40 healthy Chinese subjects, with no serious adverse events reported.

The drug showed rapid absorption and a dose-dependent increase in systemic exposure, indicating that it effectively reaches the bloodstream and maintains consistent pharmacokinetics across different doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and Safety of the Tyrosine Kinase 2 Inhibitor Deucravacitinib in Healthy Chinese Subjects. Jing, S., Lin, Y., Dockens, R., et al.[2023]

In a randomized, placebo-controlled trial, deucravacitinib, a selective TYK2 inhibitor, demonstrated significant clinical efficacy in treating moderate to severe psoriasis, with improvements in the Psoriasis Area and Severity Index (PASI) scores correlating with biomarker changes in the IL-23/TH17 and type I IFN pathways.

Deucravacitinib effectively normalized IL-23 and type I IFN pathway biomarkers in lesional skin, while showing selectivity by not affecting laboratory markers associated with JAK1-3 inhibition, indicating its targeted action on the TYK2 pathway.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular and clinical effects of selective tyrosine kinase 2 inhibition with deucravacitinib in psoriasis. Catlett, IM., Hu, Y., Gao, L., et al.[2022]

Deucravacitinib, an oral tyrosine kinase 2 inhibitor, showed significant improvements in psoriasis symptoms and quality of life as early as Week 4 in a 12-week Phase 2 trial involving adults with moderate to severe plaque psoriasis.

Patients experienced better quality of life alongside clinical improvements, indicating that as psoriasis symptoms improved, so did their overall well-being, suggesting that deucravacitinib could be a promising new treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deucravacitinib in Moderate to Severe Psoriasis: Clinical and Quality-of-Life Outcomes in a Phase 2 Trial. Thaçi, D., Strober, B., Gordon, KB., et al.[2022]

Citations

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Corporate news details New data from the pivotal Phase 3 POETYK PsA-1 trial demonstrated that Sotyktu improved and maintained meaningful clinical responses, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12188513/

Deucravacitinib in plaque psoriasis: Four‐year safety and ... In conclusion, deucravacitinib demonstrated a consistent long‐term safety profile and maintained clinical and patient‐reported efficacy outcomes through 4 years ...

3. jaad.org jaad.org/article/S0190-9622(24)01754-7/fulltext

51214 Deucravacitinib efficacy in palmoplantar and ... Deucravacitinib was effective in palmoplantar and fingernail psoriasis regardless of baseline disease severity of plaque psoriasis.

4. sotyktu.co.uk sotyktu.co.uk/scalpandnail

Scalp, palmoplantar and nail psoriasis Learn about SOTYKTU▽ (deucravacitinib), and the outcomes from scalp, nail and palmoplantar endpoints. For healthcare professionals only.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11975169/

A 52‐week prospective study stratified by prior apremilast ... Deucravacitinib decreased PASI and DLQI scores for 52 weeks in psoriasis patients, both with and without prior apremilast or biologic usage.

6. ema.europa.eu ema.europa.eu/en/documents/product-information/sotyktu-epar-product-information_en.pdf

Sotyktu, INN-deucravacitinib - European Medicines Agency 5.3 Preclinical safety data. Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose ...

7. sotyktuhcp.com sotyktuhcp.com/efficacy/patient-photos

SOTYKTU® (deucravacitinib) Patient Photos | for HCPs SEE SAFETY DATA FROM CLINICAL TRIALS ... Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: efficacy and safety ...