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Trial record 2 of 11 for:    LP0133

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

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ClinicalTrials.gov Identifier: NCT04949841
Recruitment Status : Enrolling by invitation
First Posted : July 2, 2021
Last Update Posted : October 20, 2021
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

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.


Condition or disease Intervention/treatment Phase
Chronic Hand Eczema Drug: Delgocitinib Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : August 23, 2021
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: As-needed treatment with delgocitinib
Subjects will be treated with delgocitinib cream 20 mg/g twice daily as needed.
Drug: Delgocitinib
Delgocitinib cream 20 mg/g




Primary Outcome Measures :
  1. Number of treatment-emergent adverse events from baseline up to Week 38 [ Time Frame: From baseline to Week 38 ]

Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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.

  5. 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.



Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04949841


Locations
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Canada, Alberta
LEO Investigational Site
Calgary, Alberta, Canada, T1Y 0B4
LEO Investigational Site
Calgary, Alberta, Canada, T3E 0B2
LEO Investigational Site
Edmonton, Alberta, Canada, T5J 3S9
LEO Investigational Site
Edmonton, Alberta, Canada, T6G 1C3
LEO Investigational Site
Red Deer, Alberta, Canada, T4P 1K4
Canada, British Columbia
LEO Investigational Site
Surrey, British Columbia, Canada, V3R 6A7
LEO Investigational Site
Vancouver, British Columbia, Canada, V6 4E1
Canada, New Bruswick
LEO Investigational Site
Fredericton, New Bruswick, Canada, E3B 1G9
Canada, Ontario
LEO Investigational Site
Ajax, Ontario, Canada, L1S 7K8
LEO Investigational Site
Cobourg, Ontario, Canada, K9A 4J9
LEO Investigational Site
Etobicoke, Ontario, Canada, M8X 1Y9
LEO Investigational Site
Hamilton, Ontario, Canada, L8S 1G5
LEO Investigational Site
Kingston, Ontario, Canada, K7L 2V7
LEO Investigational Site
London, Ontario, Canada, N6A 3H7
LEO Investigational Site
Markham, Ontario, Canada, L3P 1X3
LEO Investigational Site
Toronto, Ontario, Canada, M2M 4J5
LEO Investigational Site
Toronto, Ontario, Canada, M3H 5Y8
LEO Investigational Site
Windsor, Ontario, Canada, N8W 1E6
Canada, Quebec
LEO Investigational Site
Montreal, Quebec, Canada, H2X 2V1
Spain
LEO Investigational Site
Alicante, Spain, 03010
United Kingdom
LEO Investigational Sites
Redhill, Surrey, United Kingdom, RH1 5RH
Sponsors and Collaborators
LEO Pharma
Investigators
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Study Director: Medical Expert LEO Pharma
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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT04949841    
Other Study ID Numbers: LP0133-1403
2020-002962-15 ( EudraCT Number )
First Posted: July 2, 2021    Key Record Dates
Last Update Posted: October 20, 2021
Last Verified: August 2021
Individual Participant Data (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
Statistical Analysis Plan (SAP)
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Eczema
Dermatitis
Skin Diseases
Skin Diseases, Eczematous