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A Phase 2, Double-Blind, Randomized, 16-Week, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by an Open-Label Extension Period in Adults With Chronic Hand Eczema
EU CTIS ID: 2022-502827-23-00
What this study is testing
To evaluate the efficacy of ruxolitinib 1.5% cream versus vehicle cream in the treatment of participants with moderate to severe CHE.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Ability to comprehend and willingness to sign a written ICF for the study. A signed written ICF must be obtained for inclusion, see Section 8.1.1 (of the Protocol) for additional details.
- Age ≥ 18 years at the screening visit.
- Diagnosis of CHE for at least 6 months prior to screening. Diagnosis of CHE is defined as HE lasting > 3 months or ≥ 2 recurrences within the previous 12 months.
- Screening and baseline IGA-CHE score of 3 or 4.
- Baseline CHE-related Itch NRS score ≥ 4. Baseline Itch NRS score is defined as the 7-day average of Itch NRS score directly before Day 1 (data from a minimum of 4 out of 7 days prior to Day 1 is needed).
- Have been treated with at least 1 prescription CHE therapy or if such therapy was not advisable or contraindicated.
You likely can't join if
- Known triggers for CHE (allergic or irritant, such as those identified by previous patch tests) cannot be avoided during the course of the study.
- Particular clinical laboratory test results at screening: a. Cytopenias, defined as follows: Hemoglobin < 100 g/L (ie, 10 g/dL), Absolute neutrophil count < 1.5 × 109/L (ie, 1500/μL), Platelet count < 1 × 1011/L (ie, 100,000/μL) b. Liver function tests: AST or ALT ≥ 2.5 × ULN, Total bilirubin > 1.5 × ULN unless Gilbert syndrome; et al. (specified in the Study Protocol, section 5.2. Exclusion Criteria, page 28).
- Use of particular treatments within the indicated washout period before the baseline visit: a. 12 weeks or 5 half-lives, whichever is longer – biologic agents (eg, dupilumab). For biologic agents with washout periods longer than 12 weeks (eg, rituximab), consult the medical monitor. b. 4 weeks – systemic corticosteroids or adrenocorticotropic hormone analogs; cyclosporine, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (eg, mycophenolate or tacrolimus); or oral alitretinoin or any other systemic treatment for CHE. c. 4 weeks for any topical or systemic JAK or TYK2 inhibitor (eg, abrocitinib, baricitinib, brepocitinib, deucravacitinib, filgotinib, lestaurtinib, pacritinib, ruxolitinib, tofacitinib, upadacitinib). d. 2 weeks or 5 half-lives, whichever is longer – strong systemic CYP3A4 inhibitors. e. 2 weeks – systemic antibiotics, immunizations with live-attenuated vaccines, or sedating antihistamines unless on a long-term stable regimen (nonsedating antihistamines are permitted). f. 1 week – use of any topical treatments for CHE (other than bland emollients, eg, Aveeno® creams, ointments, sprays, and soap substitutes), such as corticosteroids, calcineurin inhibitors, topical antipruritics (eg, doxepin cream), phosphodiesterase 4 inhibitors, coal tar (shampoo), topical antibiotics or antifungals, and antibacterial cleansing body wash/soap.
- Psoralen ultraviolet A or ultraviolet B therapy for CHE within 4 weeks before baseline.
- Pregnant or lactating participants or those considering pregnancy during the period of their study participation.
- History of alcoholism or drug addiction within 1 year before screening or current alcohol or drug use that, in the opinion of the investigator, will interfere with the participant's ability to comply with the administration schedule and study assessments.
See the full eligibility criteria
Who can join
- Ability to comprehend and willingness to sign a written ICF for the study. A signed written ICF must be obtained for inclusion, see Section 8.1.1 (of the Protocol) for additional details.
- Age ≥ 18 years at the screening visit.
- Diagnosis of CHE for at least 6 months prior to screening. Diagnosis of CHE is defined as HE lasting > 3 months or ≥ 2 recurrences within the previous 12 months.
- Screening and baseline IGA-CHE score of 3 or 4.
- Baseline CHE-related Itch NRS score ≥ 4. Baseline Itch NRS score is defined as the 7-day average of Itch NRS score directly before Day 1 (data from a minimum of 4 out of 7 days prior to Day 1 is needed).
- Have been treated with at least 1 prescription CHE therapy or if such therapy was not advisable or contraindicated.
- Willingness to avoid pregnancy or fathering children, based on specific criteria (Male participants with reproductive potential must agree to take appropriate precautions to avoid fathering children from screening through 90 days (a spermatogenesis cycle) after the last application of ruxolitinib cream and must refrain from donating sperm during this period; Female participants who are WOCBP must have a negative serum pregnancy test at screening and negative urine pregnancy test before the first application on Day 1 and must agree to take appropriate precautions to avoid pregnancy from screening through 30 days (1 menstrual cycle) after the last application of study ruxolitinib cream and must refrain from donating oocytes during this period).
What rules you out
- Known triggers for CHE (allergic or irritant, such as those identified by previous patch tests) cannot be avoided during the course of the study.
- Particular clinical laboratory test results at screening: a. Cytopenias, defined as follows: Hemoglobin < 100 g/L (ie, 10 g/dL), Absolute neutrophil count < 1.5 × 109/L (ie, 1500/μL), Platelet count < 1 × 1011/L (ie, 100,000/μL) b. Liver function tests: AST or ALT ≥ 2.5 × ULN, Total bilirubin > 1.5 × ULN unless Gilbert syndrome; et al. (specified in the Study Protocol, section 5.2. Exclusion Criteria, page 28).
- Use of particular treatments within the indicated washout period before the baseline visit: a. 12 weeks or 5 half-lives, whichever is longer – biologic agents (eg, dupilumab). For biologic agents with washout periods longer than 12 weeks (eg, rituximab), consult the medical monitor. b. 4 weeks – systemic corticosteroids or adrenocorticotropic hormone analogs; cyclosporine, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (eg, mycophenolate or tacrolimus); or oral alitretinoin or any other systemic treatment for CHE. c. 4 weeks for any topical or systemic JAK or TYK2 inhibitor (eg, abrocitinib, baricitinib, brepocitinib, deucravacitinib, filgotinib, lestaurtinib, pacritinib, ruxolitinib, tofacitinib, upadacitinib). d. 2 weeks or 5 half-lives, whichever is longer – strong systemic CYP3A4 inhibitors. e. 2 weeks – systemic antibiotics, immunizations with live-attenuated vaccines, or sedating antihistamines unless on a long-term stable regimen (nonsedating antihistamines are permitted). f. 1 week – use of any topical treatments for CHE (other than bland emollients, eg, Aveeno® creams, ointments, sprays, and soap substitutes), such as corticosteroids, calcineurin inhibitors, topical antipruritics (eg, doxepin cream), phosphodiesterase 4 inhibitors, coal tar (shampoo), topical antibiotics or antifungals, and antibacterial cleansing body wash/soap.
- Psoralen ultraviolet A or ultraviolet B therapy for CHE within 4 weeks before baseline.
- Pregnant or lactating participants or those considering pregnancy during the period of their study participation.
- History of alcoholism or drug addiction within 1 year before screening or current alcohol or drug use that, in the opinion of the investigator, will interfere with the participant's ability to comply with the administration schedule and study assessments.
- In the EU, participants considered incapacitated (according to CTR Article 31) are excluded from the study.
- Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before the baseline visit with another investigational medication or current enrollment in another investigational drug protocol.
- Known allergy or reaction to any of the components of the study cream.
- In the opinion of the investigator are unable or unlikely to comply with the administration schedule and study evaluations.
- Committed to a mental health institution by virtue of an order issued either by the judicial or the administrative authorities.
- Employees of the sponsor or investigator or otherwise dependents of them.
- History of (within the past 5 years) or current AD or current psoriasis.
- Concurrent conditions and history of other diseases: a. Other active skin disease or infection on the hands, including tinea manuum. In addition, foot eczema is excluded; b. Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, or Wiskott-Aldrich syndrome); c. Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before baseline; d. Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chickenpox, or impetigo) within 1 week before baseline; et al.
- Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data. Examples: a. Clinically significant or uncontrolled cardiovascular disease, including unstable angina, acute myocardial infarction, or stroke within 6 months from Day 1 of study drug application, New York Heart Association Class III or IV congestive heart failure, and arrhythmia requiring therapy or uncontrolled hypertension (blood pressure > 150/90 mm Hg) unless approved by the medical monitor/sponsor; b. Participants with or a history of malignancy in the 5 years preceding the baseline visit, except for adequately treated nonmetastatic nonmelanoma skin cancer; c. Current and/or history of arterial or venous thrombosis, including deep venous thrombosis and pulmonary embolism; d. Current and/or history of active tuberculosis or current and/or history of latent tuberculosis unless adequately treated; e. History of severe anemia, severe thrombocytopenia, or severe neutropenia.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.