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NCT01941537 · ClinicalTrials.gov registry record · Phase 2
Randomized Placebo Controlled Study to Determine Safety, Pharmacodynamics and Efficacy of ILV-094 in Atopic Dermatitis
A Phase 2 study, sponsored by Rockefeller University.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT01941537 is a Phase 2 study that has completed, run by Rockefeller University. The registered enrollment target is 60 participants.
The verdict
NCT01941537, a Phase 2 study, has completed, sponsored by Rockefeller University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
Atopic dermatitis (AD) is a common inflammatory skin disorder that adversely affects most aspects of everyday life in majority of patients. It has a prevalence of up to 3-4% of adults and up to 25% among children. AD has a complex pathogenesis, characterized by: 1) immune activation with increased numbers of T-cells, dendritic cells (DCs), and increased expression of inflammatory molecules 2) marked epidermal hyperplasia in chronic diseased skin, and 3) defective barrier function with increased trans-epidermal water loss (TEWL) and decreased lipids, reflecting underlying alterations in keratinocyte differentiation. AD is predominantly a Th2 (IL-4, IL-13, and IL-31) disease, and recently was also found to be a "T22" (IL-22) polarized disease. ILV-094 is an anti IL-22 antibody and therefore should reverse the immune activation of AD. This study is being done to assess the safety, tolerability, clinical efficacy, and mechanism of action of ILV-094 in patients with AD.
Interventions
- DRUG Placebo Comparator
- DRUG ILV-094
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2013-10 |
| Est. Completion | 2019-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01941537
The ClinicalTrials.gov registry entry for NCT01941537 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rockefeller University, which has 117 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo Comparator is the first listed.
NCT01941537 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01941537 about?
NCT01941537 is a clinical study titled "Randomized Placebo Controlled Study to Determine Safety, Pharmacodynamics and Efficacy of ILV-094 in Atopic Dermatitis". Atopic dermatitis (AD) is a common inflammatory skin disorder that adversely affects most aspects of everyday life in majority of patients. It has a prevalence of up to 3-4% of adults and up to 25% among children. AD has a complex pathogenesis, characterized by: 1) immune activation with increased n...
What is the current status of trial NCT01941537?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2013-10. Estimated completion is 2019-01.
What interventions are being tested in trial NCT01941537?
The interventions under investigation include: Placebo Comparator (DRUG), ILV-094 (DRUG).
Who is sponsoring clinical trial NCT01941537?
This trial is sponsored by Rockefeller University, which has 117 total clinical trials registered on ClinicalTrials.gov.
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