Efficacy and Safety Evaluation of Deucravacitinib in Adult Patients with Chronic Hand Eczema: A Randomized, Double-Blind, Placebo-Controlled Trial
- Trial ID
- 2023-504298-19-00
- Protocol
- DECIDE
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to evaluate the **efficacy** of daily application of 6 mg BID **deucravacitinib** compared with a placebo in the treatment of adult subjects with **chronic hand eczema**. This objective is clinically relevant as it aims to determine the therapeutic potential of deucravacitinib in managing symptoms and improving the condition of patients suffering from this persistent dermatological disorder.
Secondary objectives include evaluating the health-related quality of life and safety of daily application of 6 mg BID deucravacitinib compared with a placebo in the treatment of adult subjects with chronic hand eczema. These objectives are crucial for understanding the broader impact of the treatment on patients' overall well-being and ensuring the safety profile of the medication.
Participants
The clinical trial focuses on evaluating the efficacy of deucravacitinib in treating **chronic hand eczema**. The study population comprises both male and female participants aged between 18 to 65 years, with a **body mass index (BMI)** ranging from approximately 18 to 35 kg/m². Participants are required to have a diagnosis of chronic hand eczema that has persisted for more than three months or recurred at least twice within the past year. The trial includes individuals with moderate to severe disease, as indicated by an Investigator Global Assessment (IGA) score of 3 or higher. Participants must have previously failed topical therapy for six weeks and be eligible for systemic therapy. The trial does not involve a vulnerable population. The sponsor has not provided information regarding the total number of participants. Participants are expected to comply with clinic visits and study-related procedures. The selection process ensures that all participants have provided written informed consent in accordance with regulatory and institutional guidelines.
Plans and Procedures
The clinical trial is designed as a **randomized, double-blind, placebo-controlled** study to evaluate the efficacy and safety of **deucravacitinib** in patients with **chronic hand eczema**. The trial aims to assess the therapeutic efficacy of deucravacitinib, administered as 6 mg film-coated tablets, compared to a matching placebo. The primary endpoint is defined as the percentage of patients achieving a clinical response with an Investigator Global Assessment (IGA) score of 0 or 1 and a ≥ 2-point improvement in IGA at week 16. Secondary endpoints include participant self-assessment, quality of life measures, hand eczema severity index, safety evaluations, and changes in skin physiology and histology.
The trial is expected to last until September 30, 2024, with recruitment starting on November 1, 2023. Participants will be involved for a maximum treatment period of 16 weeks. The study includes several key visits: an initial screening visit to confirm eligibility, baseline assessments, and follow-up visits at weeks 2, 4, 6, 8, 12, and 16. The end-of-study visit will coincide with the final assessment at week 16. Participants must meet specific inclusion criteria, such as having a diagnosis of chronic hand eczema for more than three months or recurring twice or more within the past 12 months, an IGA score of ≥ 3, and a history of failed topical therapy. They must also be aged 18 to 65 years, with a BMI of approximately 18-35 kg/m², and be willing to comply with study procedures.
Conditions that may lead to early termination from the study include non-compliance with study procedures, withdrawal of consent, or any adverse events that compromise participant safety. The trial is conducted under the regulatory and institutional guidelines, ensuring that all participants provide informed consent before any protocol-related procedures. The study is categorized as a Phase 4 trial, focusing on the evaluation of safety and efficacy in a non-low intervention setting.
Treatment
The clinical trial involves the administration of **SOTYKTU** 6 mg film-coated tablets, which contain the active substance **deucravacitinib**. This medication is provided in the form of film-coated tablets and is administered orally. The dosage regimen for the trial is 6 mg taken twice daily (BID), with a maximum daily dose of 12 mg. The total maximum dose over the course of the treatment period is 1344 mg. The treatment duration is set for a maximum of 16 weeks. The active substance, deucravacitinib, is of chemical origin and is classified under the ATC code L04AA56. The product is manufactured by Bristol-Myers Squibb Pharma EEIG and holds the marketing authorization number EU/1/23/1718/008.
The study also includes a **matching placebo** to the investigational medicinal product (IMP) to maintain the double-blind nature of the trial. The placebo is designed to match the appearance and administration route of the SOTYKTU tablets, ensuring that neither the participants nor the investigators can distinguish between the active treatment and the placebo. The placebo is administered orally with the same frequency as the active treatment, which is twice daily. The use of a placebo allows for a controlled comparison to evaluate the efficacy and safety of deucravacitinib in patients with chronic hand eczema.
Efficacy
The efficacy of deucravacitinib in the treatment of chronic hand eczema will be assessed through a randomized, double-blind, placebo-controlled study. The primary endpoint for evaluating therapeutic efficacy is defined as the percentage of patients achieving a clinical response, specifically an Investigator Global Assessment (IGA) score of 0 or 1, with a ≥ 2-point improvement in IGA at week 16. This endpoint will provide a measure of the clinical response to the treatment.
Secondary endpoints include several measures to further evaluate efficacy and patient outcomes. These include the Participant Self-Assessment (PSA) conducted at baseline and at weeks 2, 4, 6, 8, 12, and 16, and the Quality of Life in Hand Eczema Questionnaire (QOLHEQ) assessed at baseline and at weeks 4, 8, and 16. The Hand Eczema Severity Index (HECSI) will also be measured at baseline and at weeks 4, 8, and 16. Additionally, changes in skin physiology, histology, expression of skin barrier proteins, cytokines, immune cell extent in skin biopsies, and the transcriptome from baseline to week 16 will be evaluated.
These assessments will be conducted using validated scales and laboratory tests to ensure accurate and reliable data collection. The schedule for these assessments is designed to capture both short-term and long-term effects of the treatment, providing a comprehensive evaluation of its efficacy in managing chronic hand eczema.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Patients must have signed and dated an IRB/IEC-approved written informed consent form in accordance with regulatory and institutional guidelines before the performance of any protocol-related procedures
- Patients with diagnosis of chronic hand eczema (persisted > 3 months or returned twice or more within the past 12 months)
- Patients with moderate to severe disease and Investigator Global Assessment (IGA) score ≥ 3 (scale of 0 to 4) at screening and baseline visit.
- Patients with failed topical therapy for 6 weeks will be included and patients should be eligible for a systemic therapy
- Male or female patients aged 18 to 65 years old
- Patients with BMI (body mass index) of ca. 18-35 kg/m2
- Patients able to provide written informed consent
- Patient willing and able to comply with clinic visits and study related procedures
Exclusion Criteria
- Diagnosis of any concurrent skin disease on the hands, e.g. tinea manuum
- Evidence of chronic kidney disease with an estimated glomerular filtration rate (eGFR) of < 45 mL/min/1.73 m2 (as calculated by the Chronic Kidney Disease Epidemiology Collaboration equation) or if subject is receiving dialysis
- On current treatment for hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis, or hepatic failure, or has evidence of liver disease as indicated by persistent (confirmed by repeated tests ≥ 2 weeks apart) elevated transaminases (ala-nine aminotransferase [ALT] and/or aspartate aminotransferase [AST]) more than 2.5 times the upper limit of normal (ULN) during the screening period
- Patients with a current or history of lymphoproliferative disease; or have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphade-nopathy or splenomegaly; or have active primary or recurrent malignant disease; or have been in remission from clinically significant malignancy for less than 5 years: a) Patients with cervical carcinoma in situ that has been appropriately treated with no evidence of recurrence or metastatic disease for at least 3 years may participate in the study. b) Patients with basal cell or squamous epithelial skin cancers that have been appropriately treated with no evidence of recurrence for at least 3 years may participate in the study
- History of allergy to any component of the study medication
- History of alcohol or drug abuse within 2 years before the screening visit
- Known history of human immunodeficiency virus (HIV) infection or HIV seropositivity
- Current diagnosis of hepatitis B viral infection at the time of screening as evidenced by a) Positive hepatitis B surface antigen (HBsAg) OR b) Positive total hepatitis B core antibody (HBcAb) confirmed by positive HBV DNA
- Current diagnosis of hepatitis C viral infection at the time of screening as evidence by a) Positive HCV Ab AND b) Positive HCV RNA
- Patients who have any of the following specific abnormalities on screening laboratory tests: a) hemoglobin <10.0 g/dL (100.0 g/L), b) total white blood cell count <2500 cells/µL, c) neutropelymphonia (absolute neutrophil count [ANC] <1000 cells/µL), d) penia (lymphocyte count <750 cells/µL), e) thrombocytopenia (platelets <100,000/µL), f) alkaline phosphatase >3x upper limit of normal (ULN) or alkaline phosphatase >2,5x ULN and total bilirubin > 2x ULN, g) aspartate transaminase (AST, SGOT) and alanine transaminase (ALT, SGPT) > 2.5x upper limit of normal (ULN)
- Treatment with any of the following agents: Janus kinase inhibitors, immunosuppres-sive/immunomodulating drugs including but not limited to methotrexate, azathioprine, dapsone, leflunomide, mycophenolate-mofetil; retinoids (e.g. alitretinoin); cyclospor-ine; sulphasalasine, hy-droxychloroquine sulphate, TNF-alpha inhibitors (etaner-cept, adalimumab, alefacept), colchicine, and IFN-γ within 1 month prior to screening.
- Active AD requiring medical treatment in regions other than the hands
- Diagnosis of tuberculosis (TB) with a positive QuantiFER-ON-TB Gold Plus test or high TB risk after assessment of recent close or prolonged contact with someone with in-fectios TB disease (defined as within the last 12 months) and/or recent travel to or from a high burden country of TB (as listed by the WHO, https://www.who.int/news/item/17-06-2021-who-releases-new-global-lists-of-high-burden-countries-for-tb-hiv-associated-tb-and-drug-resistant-tb)
- Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 14 days prior to baseline
- Use of a live vaccine 90 days prior to screening, or during this study
- Patients, who are older than 50 years and do not have a vaccination against Herpes zoster
- Active infection(s) requiring treatment with intravenous anti-infectives within 30 days, or oral/intramuscular anti-infectives within 14 days prior to the Baseline Visit
- Subject is currently enrolled in another investigational device or drug trial(s), has re-ceived investigational drug within 90 days before baseline visit
- Pregnant or breastfeeding women or planning to become pregnant or breastfeed during the patient’s participation in this study
- Women of childbearing potential (WOCBP) who are unwilling to practice highly effec-tive contraception prior to the initial dose/start of the first treatment, during the study, and for at least 30 days after the last dose.
- Potential subjects who are in a dependent/employment relationship with the sponsor, investigator or clinical trial site.
- Active psoriasis or severe acneiforme skin disease on any part of the body
- Potential subjects who are placed in an institution due to a court or official order
- Presence of skin comorbidities that may interfere with the study assessments
- Clinically significant infection (e.g. impetiginised hand eczema) on the hands
- Severe concomitant illness(es) that, in the investigator’s judgment, would adversely af-fect the patient’s participation in the study. Patients with uncontrolled diabetes (HbA1c ≥ 9%), patients with cardiovascular conditions including stage III or IV cardiac failure according to the New York Heart Association classification (recent cerebrovascular accidents, myocardial infarction, coronary stenting or moderate to severe congestive heart failure), severe renal conditions (eg, patients on dialysis), neurological conditions (eg, demyelinating diseases), active major autoimmune diseases (eg, Eosinophilic granulomatosis with polyangitis (EGPA), lupus, inflammatory bowel disease, rheuma-toid arthritis, etc.), other severe endocrinological, gastrointestinal, hepatobiliary (e.g. Pugh type C, severe liver insufficiency), metabolic, pulmonary or lymphatic diseases
- History or presence of epilepsy, significant neurological disorders, severe depression, suicidal ideation and behavior, cerebrovascular attacks or ischemia
- Patients with an active, severe infection in anamnesis and a chronic infection should be excluded from the clinical trial
- Presence of myocardial infarction (within the last 3 months) or cardiac arrhythmia requiring drug therapy in combination with a general increased risk of cardiovascular disease
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Germany | Not Recruiting | 01 Nov 2023 | 57 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
Matching placebo to IMP | Placebo | N/A | — | — | — | N/A |
SOTYKTU 6 mg film-coated tablets | Test | FILM-COATED TABLETS | ORAL | 12 | 16 | PRD10314809 |