Open-label Multi-site Extension Trial in Subjects Who Completed the DELTA 1 or DELTA 2 Trials (DELTA3)

• ClinicalTrials.gov Identifier: NCT04949841
• Recruitment Status: Completed
• First Posted: July 2, 2021
• Last Update Posted: December 7, 2023
• Sponsor: LEO Pharma
• Information provided by (Responsible Party): LEO Pharma

Tracking Information

• First Submitted Date: June 29, 2021
• First Posted Date: July 2, 2021
• Last Update Posted Date: December 7, 2023
• Actual Study Start Date: August 23, 2021
• Actual Primary Completion Date: September 18, 2023 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 29, 2021): Number of treatment-emergent adverse events from baseline up to Week 38 [ Time Frame: From baseline to Week 38 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 29, 2021)

• IGA-CHE score at each scheduled visit from baseline up to Week 36 [ Time Frame: From baseline to Week 36 ]
  The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is an instrument used in clinical trials to rate the severity of the participant's chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
• IGA-CHE score of 0 (clear) or 1 (almost clear) at each scheduled visit from baseline up to Week 36. [ Time Frame: From baseline to Week 36 ]
  The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is an instrument used in clinical trials to rate the severity of the participant's chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
• HECSI score at each scheduled visit from baseline up to Week 36 [ Time Frame: From baseline to Week 36 ]
  The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score).
• HECSI-75 at each scheduled visit from baseline up to Week 36 [ Time Frame: From baseline to Week 36 ]
  The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score). HECSI-75 is defined as at least 75% improvement in HECSI score from parent trial baseline.
• HECSI-90 at each scheduled visit from baseline up to Week 36 [ Time Frame: From baseline to Week 36 ]
  The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score). HECSI-90 is defined as at least 90% improvement in HECSI score from parent trial baseline.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Open-label Multi-site Extension Trial in Subjects Who Completed the DELTA 1 or DELTA 2 Trials
• Official Title: A Phase 3 Extension Trial of DELTA 1 and DELTA 2 to Evaluate the Long-term Safety of a Twice-daily Treatment With Delgocitinib Cream 20 mg/g as Needed for up to 36 Weeks in Adult Subjects With Chronic Hand Eczema (DELTA 3)

Brief Summary

The purpose of this extension trial is to evaluate the long-term safety of delgocitinib.

Subjects will visit the clinic every 4 week to assess the safety and efficacy of the treatment, until Week 36. A final follow-up phone call is planned on Week 38.

Detailed Description

Subject who completed 16 weeks of treatment with delgocitinib cream 20 mg/g or vehicle cream twice daily in trials DELTA 1 or DELTA 2 will be offered to roll-over to this extension trial.

Subjects will be treated with delgocitinib cream 20 mg/g twice daily only if they need it to control their chronic hand eczema. In the periods when the disease is controlled, no treatment will be administered.

Clinic visits every 4 weeks are planned (with the possibility of unscheduled visits) to investigate safety and efficacy of treatment, as well as its effect on patient-reported outcomes (PROs).

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Chronic Hand Eczema

Intervention

Drug: Delgocitinib

Delgocitinib cream 20 mg/g

Study Arms

Experimental: As-needed treatment with delgocitinib

Subjects will be treated with delgocitinib cream 20 mg/g twice daily as needed.

Intervention: Drug: Delgocitinib

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 4, 2023): 801
• Original Estimated Enrollment (submitted: June 29, 2021): 600
• Actual Study Completion Date: September 18, 2023
• Actual Primary Completion Date: September 18, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Participants must have met eligibility criteria at screening and baseline in the parent trial (DELTA 1 or DELTA 2).
• Participants must have completed the treatment period in the parent trial (to be assessed at baseline visit in this extension trial).
• Participants must have complied with the clinical trial protocol in the parent trial to the satisfaction of the investigator.
• A woman of childbearing potential must use an acceptable method of birth control throughout the trial up until the end-of-treatment/early termination visit.

Exclusion Criteria:

• Participants who prematurely discontinued treatment with IMP or initiated rescue medication in the parent trial.
• Participants who experienced any adverse event (AE) during participation in the parent trial, which precludes further treatment with delgocitinib cream 20 mg/g in the judgement of the investigator.
• Any medical or psychiatric condition that could put the participant at undue risk by participating in the trial, or which, by the investigator's judgment, makes the participant inappropriate for the trial.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Poland, Spain, United Kingdom

Administrative Information

• NCT Number: NCT04949841
• Other Study ID Numbers: LP0133-1403; 2020-002962-15 ( EudraCT Number )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: De-identified IPD can be made available to researchers in a closed environment for a specified period of time.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Clinical Study Report (CSR)
• Time Frame: Data is available to request after results of the trial are available on leopharmatrials.com
• Access Criteria: Data-sharing is subject to approved scientifically sound research proposal and signed data-sharing agreement.
• URL: http://leopharmatrials.com/for-professionals

• Current Responsible Party: LEO Pharma
• Original Responsible Party: Same as current
• Current Study Sponsor: LEO Pharma
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Medical Expert; LEO Pharma

• PRS Account: LEO Pharma
• Verification Date: December 2023