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Trial record 100 of 740 for:    "Dermatitis, Atopic"

Investigation of Flare and Remission in Subjects With Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT03710044
Recruitment Status : Not yet recruiting
First Posted : October 17, 2018
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Brief Summary:
The trial is an exploratory, single-centre, uncontrolled, open-label, interventional trial of up to 19 weeks' duration to investigate flare and remission in subjects with moderate-to-severe atopic dermatitis (AD) treated with cyclosporine A (CsA).

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Cyclosporine A Phase 4

Detailed Description:

40 subjects with moderate-to-severe AD will be treated with a 3-week course of high-dose CsA, which is a standard-of-care treatment regimen. After 3 weeks, all responders shift to oral low-dose CsA treatment (2-2.5 mg/kg/day) until onset of a second flare or until Week 16 (Day 113).

In case of a second AD flare, the subjects shift back to oral high-dose CsA treatment (4-5 mg/kg/day) for 3 weeks.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Investigation of Flare and Remission in Atopic Dermatitis in an Integrated Longitudinal Trial: Effects of Systemic Treatment With Cyclosporine A
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Cyclosporine A treatment
Oral cyclosporine A treatment
Drug: Cyclosporine A

Initial treatment: Oral cyclosporine A (CsA) treatment (4-5 mg/kg/day) for 3 weeks.

Responders shift to oral low-dose CsA treatment (2-2.5 mg/kg/day) until onset of a second flare or until Week 16 (Day 113).

In case of a second AD flare, the subjects shift back to oral high-dose CsA treatment (4-5 mg/kg/day) for 3 weeks.





Primary Outcome Measures :
  1. Time to flare* in subjects with moderate-to-severe AD who responded to a 3-week course of high-dose CsA treatment. [ Time Frame: Day 1 to Day 113 (end of trial) ]
    *A flare is defined as exacerbation of the disease, where intensification of medicine is considered necessary.


Secondary Outcome Measures :
  1. Number of treatment-emergent adverse events (TEAEs) up until end of trial. [ Time Frame: Up to Day 113 (end of trial) ]
  2. Number of subjects with TEAEs up until end of trial. [ Time Frame: Up to Day 113 (end of trial) ]


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

Main Inclusion Criteria:

  • Diagnosis and history of chronic, moderate-to-severe AD (by the Eichenfield revised criteria of Hanifin and Rajka) for at least 3 years before the screening visit.
  • Subjects who have an AD flare at the start of the trial (EASI score ≥10 at screening and ≥16 at the baseline visit).

Main Exclusion Criteria:

  • Treatment with allergen immunotherapy within 6 months before the baseline visit.
  • Treatment with leukotriene inhibitors, systemic glucocorticoids, or other systemic treatment for AD (including immunosuppressive treatment, ultraviolet therapy, and biologics) within 4 weeks before the baseline visit.
  • Treatment with topical corticosteroids or topical calcineurin inhibitors within 1 week before the baseline visit.
  • Chronic or acute infection requiring treatment with oral or intravenous antibiotics, anti-virals, anti-parasitics, anti-protozoals, or anti-fungals within 4 weeks before the screening visit or superficial skin infections within 1 week before the screening visit.
  • History of malignancy within 5 years before the baseline visit, with the following exceptions: subjects with a history of completely treated carcinoma in situ of cervix, and non-metastatic squamous or basal cell carcinoma of the skin are allowed.
  • Hypertension (>150/95 mmHg) at the screening visit.
  • Planned surgical procedure during the length of the subject's participation in this trial.
  • Use of a tanning booth/parlour within 4 weeks before the screening visit.
  • Pregnant, breastfeeding, or lactating women.
  • Laboratory abnormalities at the screening visit.

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): NCT03710044


Contacts
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Contact: LEO Pharma A/S (+1) 877-557-1168 disclosure@leo-pharma.com

Locations
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Netherlands
Investigational site Not yet recruiting
Rotterdam, Netherlands, 3015 GD
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: NCT03710044     History of Changes
Other Study ID Numbers: EXP-1392
2018-000229-30 ( EudraCT Number )
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by LEO Pharma:
atopic dermatitis
cyclosporine A
atopic dermatitis pathophysiology

Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors