Atopic DermatitisPhase 4NCT03710044
Investigation of Flare and Remission in Subjects With Atopic Dermatitis
A Phase 4 study testing Cyclosporine A in people with Atopic Dermatitis, run by LEO Pharma at 1 site in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Cyclosporine A
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteNetherlands
- Study dates
- 14 Jan 2019to Aug 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Flare and Remission in Atopic Dermatitis in an Integrated Longitudinal Trial: Effects of Systemic Treatment With Cyclosporine A
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).
Read the 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.
- Conditions
- Atopic Dermatitis
- Being tested
- Cyclosporine A
- Keywords
- atopic dermatitis, cyclosporine A, atopic dermatitis pathophysiology
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclosporine ADrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Cyclosporine A treatment | Experimental | Oral cyclosporine A treatment Receives: Drug: Cyclosporine A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 to Day 113 (end of trial)
Secondary outcomes (2)
Number of treatment-emergent adverse events (TEAEs) up until end of trial.
Measured: Up to Day 113 (end of trial)
Number of subjects with TEAEs up until end of trial.
Measured: Up to Day 113 (end of trial)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start14 Jan 2019
- Primary completionAug 2020 (estimated)
- Study completionAug 2020 (estimated)
Why it stopped: Strategic decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Expert, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03710044
- Sponsor's protocol ID
- EXP-1392
- Other IDs
- 2018-000229-30, 2018
- Status last verified
- Jul 2019
- First submitted
- 16 Oct 2018
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Flare and Remission in Atopic Dermatitis in an Integrated Longitudinal Trial: Effects of Systemic Treatment With Cyclosporine A
- ClinicalTrials.gov ID
- NCT03710044
- Acronym / sponsor ID
- EXP-1392
- Conditions
- Atopic Dermatitis
- Keywords
- atopic dermatitis, cyclosporine A, atopic dermatitis pathophysiology
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Strategic decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 17 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cyclosporine A treatment | Experimental | Drug: Cyclosporine AOral cyclosporine A treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyclosporine AInitial 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. | Drug | Cyclosporine A treatment |
Primary outcome
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.
2 secondary outcomes
Number of treatment-emergent adverse events (TEAEs) up until end of trial.
Time frame: Up to Day 113 (end of trial)
Number of subjects with TEAEs up until end of trial.
Time frame: Up to Day 113 (end of trial)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Expert study director
LEO Pharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cyclosporine A in people with Atopic Dermatitis, run by LEO Pharma at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.