Deucravacitinib for Hidradenitis Suppurativa
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Beth Israel Deaconess Medical Center
Must not be taking: TNF agents, Biologics, Opioids, others
Disqualifiers: Active skin disease, Malignancy, Infectious disease, others
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?This trial tests if Deucravacitinib can help adults with Hidradenitis Suppurativa by reducing inflammation and painful lumps through calming the immune system.
Will I have to stop taking my current medications?
The trial requires stopping certain medications before starting, such as non-biologic treatments for HS, TNF agents, new hormonal therapy, oral antibiotics, intralesional kenalog injections, and topical steroids or antibiotics. However, you may continue stable doses of some antibiotics and non-opioid pain relievers. The protocol does not specify all medications, so check with the trial team for your specific situation.
What data supports the effectiveness of the drug Deucravacitinib for treating Hidradenitis Suppurativa?
Deucravacitinib has shown effectiveness in treating moderate to severe plaque psoriasis, with a significant number of patients experiencing symptom improvement. While this is a different condition, the drug's ability to target similar inflammatory pathways may suggest potential benefits for Hidradenitis Suppurativa.
12345How does the drug Deucravacitinib differ from other treatments for hidradenitis suppurativa?
Deucravacitinib is unique because it is a selective tyrosine kinase 2 (TYK2) inhibitor, which works by targeting specific pathways involved in the immune response, unlike other treatments that may target broader immune functions. This specificity could potentially offer a novel approach to managing hidradenitis suppurativa compared to existing treatments like adalimumab, which targets tumor necrosis factor alpha (TNF-alpha).
16789Eligibility Criteria
Adults aged 18-70 with Hidradenitis Suppurativa (HS), having at least 5 abscesses or nodules and lesions in two areas. Women must test negative for pregnancy and use birth control; men cannot be trying to conceive. Excludes those with uncontrolled conditions, recent certain treatments, allergies to tetracycline antibiotics, active skin diseases that could affect HS assessment, current malignancy or history of one within the past five years (except specific treated cancers), chronic infections including HIV/Hepatitis B/C, and those on opioid analgesics.Inclusion Criteria
I have HS lesions in two different body areas.
Women of Childbearing potential must have a negative serum urine pregnancy test at screening and a negative urine pregnancy test at baseline prior to administration of the first dose of study medication
I am between 18 and 70 years old.
+4 more
Exclusion Criteria
You have a medical condition that weakens your immune system and makes it risky for you to receive immunotherapy.
I haven't taken TNF inhibitors or other biologic drugs in the last 6 weeks.
I have not taken any oral antibiotics in the last 3 weeks, or I have been on a stable dose for 4 weeks.
+14 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
4 weeks
1 visit (in-person)
Treatment
Participants receive either Deucravacitinib or placebo for 16 weeks with assessments at Baseline and weeks 4, 8, 12, and 16
16 weeks
5 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment with a follow-up phone call 4 weeks after the last study drug dose
4 weeks
1 visit (phone call)
Participant Groups
The trial is testing Deucravacitinib's safety and effectiveness against a placebo in treating HS. Participants will randomly receive either Deucravacitinib (6 mg twice daily) or a placebo for 16 weeks. The study includes a screening period before treatment starts and follows up four weeks after the last dose via phone call.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Deucravacitinib - Study DrugExperimental Treatment1 Intervention
Deucravacitinib group: 6 mg po bid x 16 weeks
Group II: PlaceboPlacebo Group1 Intervention
Placebo group: 1 tablet po bid x 16 weeks
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Beth Israel Deaconess Medical CenterBoston, MA
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Who Is Running the Clinical Trial?
Beth Israel Deaconess Medical CenterLead Sponsor
Bristol-Myers SquibbIndustry Sponsor
References
Hidradenitis suppurativa associated with sorafenib initiation. [2020]Sorafenib is a multi-kinase inhibitor approved for the treatment of renal cell and hepatocellular carcinoma. Adverse cutaneous reactions are a very common side effect of the medication. We report the development of hidradenitis suppurativa (HS) in a patient after initiation of treatment with sorafenib. HS is marked by recurrent deep painful nodules, fluctuant abscesses, and draining sinus tracts most frequently occurring in the groin and axilla. To our knowledge, sorafenib-induced HS in the axillary and inguinal skin folds has not been previously reported.
Efficacy and safety of the selective TYK2 inhibitor, deucravacitinib, in Japanese patients with moderate to severe plaque psoriasis: Subgroup analysis of a randomized, double-blind, placebo-controlled, global phase 3 trial. [2023]Deucravacitinib is an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor that demonstrated superior efficacy versus placebo and apremilast in a global phase 3 trial (POETYK PSO-1; NCT03624127) in patients with moderate to severe plaque psoriasis (N = 666). This report describes efficacy and safety in Japanese patients from this study (N = 66) who were randomly assigned to treatment with deucravacitinib 6 mg once daily (n = 32), placebo (n = 17), or apremilast 30 mg twice daily (n = 17). Patients randomized to placebo crossed over to deucravacitinib at Week 16. Patients randomized to apremilast who did not achieve ≥50% reduction from baseline in Psoriasis Area and Severity Index (PASI 50) score at Week 24 switched to deucravacitinib. The proportion of Japanese patients achieving ≥75% reduction from baseline in PASI (PASI 75) score was numerically higher with deucravacitinib versus placebo and apremilast at Week 16 (78.1% vs. 11.8% and 23.5%, respectively) and versus apremilast at Week 24 (78.1% vs. 29.4%). A numerically higher proportion of patients achieved a static Physician's Global Assessment score of 0 or 1 (clear or almost clear) with at least a two-point improvement from baseline (sPGA 0/1) with deucravacitinib versus placebo or apremilast at Week 16 (75.0% vs. 11.8% and 35.3%) and versus apremilast at Week 24 (75.0% vs. 29.4%). Findings for other clinical and patient-reported outcomes also favored deucravacitinib. Response rates were maintained through 52 weeks in the deucravacitinib group. Incidence rates for adverse events per 100 person-years (PY) in the Japanese patients were comparable across treatment groups through Week 52 (deucravacitinib, 336.8/100 PY; placebo, 321.0/100 PY; apremilast, 358.6/100 PY). The most frequently reported adverse event with deucravacitinib was nasopharyngitis. The efficacy and safety of deucravacitinib in Japanese patients was consistent with those in the global population in POETYK PSO-1.
SOTYKTUTM (Deucravacitinib 6-mg Tablets)- A New Agent for the Management of Adult Plaque Psoriasis. [2023]SOTYKTUTM (deucravacitinib) is a newly approved oral agent for managing moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Deucravacitinib is a highly selective allosteric tyrosine kinase 2 inhibitor targeting dysregulated cytokine responses in psoriasis patients. Its efficacy was demonstrated in two randomized, placebo- and active comparator-controlled phase 3 trials, where a significantly higher proportion of patients, up to 58.4% (194/332), achieved lessening of symptoms at week 16. The recommended dosing regimen of deucravacitinib is 6 mg once daily. More frequent adverse reactions occurring in the deucravacitinib-treated patients include upper respiratory infection (19.2% [161/840]), increase in blood creatine phosphokinase (2.7% [23/840]), herpes simplex infection (2.0% [17/840]), mouth ulcers (1.9% [16/840]), folliculitis (1.7% [14/840]), and acne (1.4% [12/840]). Continuance of treatment for up to week 52 did not increase the exposure-adjusted rates of adverse reactions. The selectivity and specificity of deucravacitinib treatment may improve its long-term safety profile, compared to other Janus kinase inhibitors.
Pharmacokinetics and Safety of the Tyrosine Kinase 2 Inhibitor Deucravacitinib in Healthy Chinese Subjects. [2023]Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, blocks cytokine signaling involved in psoriasis pathogenesis. This ethnic-bridging study evaluated deucravacitinib pharmacokinetics, tolerability, and safety in healthy Chinese subjects.
Deucravacitinib in Moderate to Severe Psoriasis: Clinical and Quality-of-Life Outcomes in a Phase 2 Trial. [2022]Deucravacitinib is an oral, selective tyrosine kinase 2 inhibitor that demonstrated therapeutic benefit in a Phase 2 clinical trial of adults with moderate to severe plaque psoriasis. This analysis was designed to evaluate the effect of deucravacitinib on additional clinical and quality-of-life (QoL) outcomes and assess the relationship between these outcomes in adults with psoriasis.
Efficacy and Safety of Biologics and Small Molecules for Moderate-to-Severe Hidradenitis Suppurativa: A Systematic Review and Network Meta-Analysis. [2023]Background: Treatment of hidradenitis suppurativa (HS) is difficult and current guidelines are based mainly on expert opinion and non-randomized controlled trials. Recently, there have been some targeted therapies using uniform primary endpoints for outcome assessment. Objective: Recommendations can be provided on selecting biologics and targeted synthetic small molecules for refractory HS by comparing the efficacy and safety of these medications. Methods: Databases including ClinicalTrial.gov, Cochrane Library, and PubMed were searched. Randomized controlled trials (RCTs) for moderate-to-severe HS were eligible. We performed random-effect network meta-analysis and ranking probability. The primary outcome was Hidradenitis Suppurativa Clinical Response (HiSCR) at 12-16 weeks. Secondary outcome included Dermatology Life Quality Index (DLQI) 0/1, mean change of DLQI from baseline, and adverse effects. Results: A total of 12 RCTs involving 2915 patients were identified. Adalimumab, bimekizumab, secukinumab 300 mg q4w and secukinumab 300 mg q2w showed superiority to placebo in HiSCR at weeks 12 to 16. In addition, there was no significant difference between bimekizumab and adalimumab as measured by HiSCR (RR = 1.00; 95% CI: 0.66-1.52) and DLQI 0/1 (RR = 2.40, 95% CI: 0.88-6.50). In terms of ranking probability for achieving HiSCR at 12-16 weeks, adalimumab ranked first, followed by bimekizumab, secukinumab 300 mg q4w, and secukinumab 300 mg q2w. All biologics and small molecules did not differ in the development of adverse effects compared to placebo. Conclusions: Adalimumab, bimekizumab, secukinumab 300 mg q4w and secukinumab 300 mg q2w represent four regimens that produce better outcomes than placebo without increased risk of adverse events. Adalimumab and bimekizumab exhibited best HiSCR and DLQI 0/1 between weeks 12-16.
Hidradenitis suppurativa in Crohn's disease during adalimumab therapy: a paradox? [2019]A sporadic association between hidradenitis suppurativa and other diseases is reported in the literature, but few authors have described the association with Crohn's disease. Adalimumab is a fully human monoclonal antibody targeted at tumor necrosis factor alpha approved for the treatment of Crohn's disease and, recently, for active moderate to severe hidradenitis suppurativa in adult patients that do not respond adequately to systemic conventional treatment. We report an unusual case of a paradoxical effect of adalimumab in the onset of hidradenitis suppurativa in a 40-year-old woman during the treatment of Crohn's disease.
A proof-of-concept open-label clinical trial of spleen tyrosine kinase antagonism using fostamatinib in moderate-to-severe hidradenitis suppurativa. [2023]Hidradenitis suppurativa (HS) is an autoinflammatory disorder of keratinization with a prominence of B cells and plasma cells. Fostamatinib is a spleen tyrosine kinase inhibitor targeting B cells and plasma cells.
Achieving Hidradenitis Suppurativa Response Score is Associated with Significant Improvement in Clinical and Patient-reported Outcomes: Post Hoc Analysis of Pooled Data From PIONEER I and II. [2019]Hidradenitis Suppurativa Clinical Response (HiSCR), is a validated tool that has been used to assess the efficacy of adalimumab among patients with hidradenitis suppurativa. We evaluated the clinical meaning of HiSCR by relating it to patient-reported outcomes to give further context to its achievement in a post hoc analysis of integrated data from two phase 3 clinical trials (PIONEER I and II). Pooling placebo and active treatment arms, 39% of patients (245/629) achieved HiSCR at week 12. Irrespective of treatment, significantly (p