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Investigation of Flare and Remission in Subjects With Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status

Withdrawn

Phase

Phase 4

Locations

Netherlands

Study Type

Interventional

Intervention

Cyclosporine A

About this trial

This is an interventional other trial for Atopic Dermatitis focused on measuring atopic dermatitis, cyclosporine A, atopic dermatitis pathophysiology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Investigational site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cyclosporine A treatment

Arm Description

Oral cyclosporine A treatment

Outcomes

Primary Outcome Measures

Time to flare* in subjects with moderate-to-severe AD who responded to a 3-week course of high-dose CsA treatment.

*A flare is defined as exacerbation of the disease, where intensification of medicine is considered necessary.

Secondary Outcome Measures

Number of treatment-emergent adverse events (TEAEs) up until end of trial.

Number of subjects with TEAEs up until end of trial.

Full Information

NCT ID

NCT03710044

First Posted

October 16, 2018

Last Updated

July 9, 2019

Sponsor

LEO Pharma

1. Study Identification

Unique Protocol Identification Number

NCT03710044

Brief Title

Investigation of Flare and Remission in Subjects With Atopic Dermatitis

Official Title

Investigation of Flare and Remission in Atopic Dermatitis in an Integrated Longitudinal Trial: Effects of Systemic Treatment With Cyclosporine A

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Withdrawn

Why Stopped

Strategic decision

Study Start Date

August 2019 (Anticipated)

Primary Completion Date

August 2020 (Anticipated)

Study Completion Date

August 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

LEO Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis

Keywords

atopic dermatitis, cyclosporine A, atopic dermatitis pathophysiology

7. Study Design

Primary Purpose

Other

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cyclosporine A treatment

Arm Type

Experimental

Arm Description

Oral cyclosporine A treatment

Intervention Type

Drug

Intervention Name(s)

Cyclosporine A

Intervention Description

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 Measure Information:

Title

Time to flare* in subjects with moderate-to-severe AD who responded to a 3-week course of high-dose CsA treatment.

Description

*A flare is defined as exacerbation of the disease, where intensification of medicine is considered necessary.

Time Frame

Day 1 to Day 113 (end of trial)

Secondary Outcome Measure Information:

Title

Number of treatment-emergent adverse events (TEAEs) up until end of trial.

Time Frame

Up to Day 113 (end of trial)

Title

Number of subjects with TEAEs up until end of trial.

Time Frame

Up to Day 113 (end of trial)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Expert

Organizational Affiliation

LEO Pharma

Official's Role

Study Director

Facility Information:

Facility Name

Investigational site

City

Rotterdam

ZIP/Postal Code

3015 GD

Country

Netherlands

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Investigation of Flare and Remission in Subjects With Atopic Dermatitis

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