Investigation of Flare and Remission in Subjects With Atopic Dermatitis

NCT03710044 | Withdrawn Phase 4

• 2 other identifiers: EXP-13922018-000229-30
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Atopic Dermatitis

Keywords

atopic dermatitis; cyclosporine A; atopic dermatitis pathophysiology

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1 to Day 113 (end of trial)

Secondary Outcomes (2)

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

  Up to Day 113 (end of trial)

• Number of subjects with TEAEs up until end of trial.

  Up to Day 113 (end of trial)

Study Arms (1)

Cyclosporine A treatment

EXPERIMENTAL

Oral cyclosporine A treatment

Drug: Cyclosporine A

Interventions

Cyclosporine A DRUG

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.

Cyclosporine A treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

Investigational site

Rotterdam, 3015 GD, Netherlands

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Cyclosporine

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Medical Expert

  LEO Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: October 17, 2018
• Study Start: January 14, 2019
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: November 7, 2024

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)