Phase 2b Dose-ranging Trial to Evaluate Delgocitinib Cream 1, 3, 8, and 20 mg/g Compared to Delgocitinib Cream Vehicle Over a 16-week Treatment Period in Adult Subjects With Chronic Hand Eczema

• ClinicalTrials.gov Identifier: NCT03683719
• Recruitment Status: Completed
• First Posted: September 25, 2018
• Last Update Posted: October 14, 2020
• Sponsor: LEO Pharma
• Information provided by (Responsible Party): LEO Pharma

Study Description

Brief Summary:

This is a double-blind, multi-centre, randomised, 5-arm, vehicle-controlled, parallel-group trial. The trial is designed to establish a dose-response signal and to investigate the efficacy and safety of delgocitinib cream in the treatment of adult subjects with mild to severe chronic hand eczema.

Condition or disease	Intervention/treatment	Phase
Chronic Hand Eczema	Drug: Delgocitinib cream; Drug: Delgocitinib cream vehicle	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 258 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 2b, Double-blind, Randomised, 5-arm, Vehicle-controlled, Dose-ranging Trial to Evaluate the Efficacy and Safety of Twice Daily Topical Application of Delgocitinib Cream 1, 3, 8, and 20 mg/g for 16 Weeks in Adult Subjects With Mild to Severe Chronic Hand Eczema
• Actual Study Start Date: December 7, 2018
• Actual Primary Completion Date: March 6, 2020
• Actual Study Completion Date: April 20, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Delgocitinib cream 1 mg/g; Delgocitinib cream applied twice daily for 16 weeks.	Drug: Delgocitinib cream; Cream for topical application.; Other Name: LEO 124249 cream
Experimental: Delgocitinib cream 3 mg/g; Delgocitinib cream applied twice daily for 16 weeks.	Drug: Delgocitinib cream; Cream for topical application.; Other Name: LEO 124249 cream
Experimental: Delgocitinib cream 8 mg/g; Delgocitinib cream applied twice daily for 16 weeks.	Drug: Delgocitinib cream; Cream for topical application.; Other Name: LEO 124249 cream
Experimental: Delgocitinib cream 20 mg/g; Delgocitinib cream applied twice daily for 16 weeks.	Drug: Delgocitinib cream; Cream for topical application.; Other Name: LEO 124249 cream
Placebo Comparator: Delgocitinib cream vehicle; Delgocitinib cream vehicle applied twice daily for 16 weeks.	Drug: Delgocitinib cream vehicle; The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.; Other Name: LEO 124249 cream vehicle

Outcome Measures

Primary Outcome Measures :

1. Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) with at least a 2-step improvement (IGA treatment success) from baseline to Week 16. [ Time Frame: Week 0 to Week 16. ]
   IGA is an instrument used in clinical trials to rate the severity of subject's global disease stage and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).

Secondary Outcome Measures :

1. Change in Hand Eczema Severity Index (HECSI) from baseline to Week 16. [ Time Frame: Week 0 to Week 16. ]
   HECSI is an instrument used in clinical trials to rate the severity of 6 clinical signs of hand eczema and the extent of the lesions on each of 5 hand areas by use of standard scales. The total HECSI score is based on a 4-point severity scale ranging from 0 (none/absent) to 3 (severe) and a 5-point scale rating the affected area(s) ranging from 0 (0% affected area) to 4 (76% to 100% affected area).
2. Time to IGA treatment success. [ Time Frame: Week 0 to Week 16. ]
   Time to IGA treatment success response is defined as the time from baseline to first assessment of an IGA score of 0 (clear) or 1 (almost clear) with at least a 2-step improvement.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Key Inclusion Criteria:

• Age 18 years or above.
• Diagnosis of chronic hand eczema defined as hand eczema, which has persisted for more than 3 months or returned twice or more within the last 12 months.
• Disease severity graded as mild to severe according to IGA (i.e., IGA ≥2).
• Recent history (within 1 year before the screening visit) of inadequate response to topical corticosteroid treatment or topical corticosteroid treatment being medically inadvisable.
• Diagnostic patch testing performed within 3 years prior to the screening visit.

Key Exclusion Criteria:

• Concurrent skin diseases on the hands e.g tinnea manuum.
• Active atopic dermatitis in regions other than the hands or psoriasis requiring medical treatment.
• Clinically significant infection (e.g., impetiginised hand eczema) on the hands.
• Systemic treatment with immunosuppressive drugs, immunomodulating drugs, retinoids, or corticosteroids within 4 weeks prior to baseline.
• Psoralen ultraviolet A (PUVA) or ultraviolet B (UVB) therapy on the hands within 4 weeks prior to baseline.
• Receipt of live attenuated vaccines 4 weeks prior to baseline.
• Cutaneously applied treatment with immunomodulators (e.g., phosphodiesterase-4 (PDE-4) inhibitors, pimecrolimus, tacrolimus) or topical corticosteroids on the hands within 2 weeks prior to baseline.
• Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 2 weeks prior to baseline.
• Change in systemic antihistamine therapy within 2 weeks prior to baseline i.e., subjects must not start antihistamine treatment or change the current dosage regime within 2 weeks prior to baseline.
• Other cutaneously applied therapy on the hands (except for the use of subject's own emollients) within 1 week prior to baseline.
• Cutaneously applied treatments in regions other than the hands, which could interfere with clinical trial evaluations or pose a safety concern within 1 week prior to baseline.
• Receipt of any marketed or investigational biologic agents within 6 months or 5 half-lives prior to baseline or until cells count returns to normal, whichever is longer.
• Clinically significant infection (systemic infection or serious skin infection requiring parenteral treatment) within 4 weeks prior to baseline.
• Tuberculosis requiring treatment within 12 months prior to screening and/or subjects with a positive blood test for tuberculosis at screening.
• History of any known primary immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test at screening, or the subject taking antiretroviral medications.
• Any disorder which is not stable and in the investigator's opinion could affect the safety of the subject, influence the findings of the trial, or impede the subject's ability to complete the trial.
• Positive hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B core antibody (HBcAb), or hepatitis C virus antibody (anti-HCV) serology at screening. Subjects with positive HBsAb may be randomised provided they are hepatitis B vaccinated and have negative HBsAg and HBcAb.

Contacts and Locations

Locations

United States, Arizona

Leo Pharma Investigational Site

Tucson, Arizona, United States, 85724

United States, Florida

Leo Pharma Investigational Site

Hialeah, Florida, United States, 33012

United States, Oregon

Leo Pharma Investigational Site

Portland, Oregon, United States, 97223

Leo Pharma Investigational Site

Portland, Oregon, United States, 97239-4501

Denmark

Leo Pharma Investigational Site

Aarhus, Denmark, 8200

Leo Pharma Investigational Site

Copenhagen, Denmark, 2400

Leo Pharma Investigational Site

Hellerup, Denmark, 2900

LEO Pharma Investigational Site

Herlev, Denmark, 2730

Germany

Leo Pharma Investigational Site

Berlin, Germany, 10117

Leo Pharma Investigational Site

Bochum, Germany, 44791

Leo Pharma Investigational Site

Bremerhaven, Germany, 27574

Leo Pharma Investigational Site

Dresden, Germany, 01307

Leo Pharma Investigational Site

Düsseldorf, Germany, 40225

Leo Pharma Investigational Site

Gera, Germany, 07548

Leo Pharma Investigational Site

Göttingen, Germany, 37075

Leo Pharma Investigational Site

Jena, Germany, 07743

Leo Pharma Investigational Site

Kiel, Germany, 24105

Leo Pharma Investigational Site

Kiel, Germany, 24148

Leo Pharma Investigational Site

Langenau, Germany, 89129

Leo Pharma Investigational Site

Lübeck, Germany, 23538

Leo Pharma Investigational Site

Mahlow, Germany, 15831

Leo Pharma Investigational Site

Mainz, Germany, 55101

Leo Pharma Investigational Site

Memmingen, Germany, 87700

Leo Pharma Investigational Site

München, Germany, 80337

Leo Pharma Investigational Site

Selters, Germany, 56242

Leo Pharma Investigational Site

Stuttgart, Germany, 70178

Leo Pharma Investigational Site

Stuttgart, Germany, 70499

Leo Pharma Investigational Site

Wuppertal, Germany, 42287

Sponsors and Collaborators

LEO Pharma

Investigators

• Study Director: Medical Expert; LEO Pharma

More Information

• Responsible Party: LEO Pharma
• ClinicalTrials.gov Identifier: NCT03683719
• Other Study ID Numbers: LP0133-1273
• First Posted: September 25, 2018
• Last Update Posted: October 14, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)
• URL: https://www.leopharmatrials.com/For-professionals

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Eczema; Dermatitis; Skin Diseases; Skin Diseases, Eczematous