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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: Completed Phase 2 study, sponsored by Rockefeller University.
NCT01941537 is a Phase 2 study that has completed, run by Rockefeller University. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Percentage Change in the Scoring of Atopic Dermatitis (SCORAD) at week 12 compared to baseline in both arms of the study in subjects with atopic dermatitis. SCORAD (Severity scoring of Atopic Dermatitis) is composite severity index comprising a) the amount/extent of body surface area affected, b) subjective symptom visual analog assessments \[itchy 0 (no itching) to 3 (severe itching) and sleep disturbance 0(no sleep disturbance) to 3 (severe sleep disturbance)\], and c) 6 disease intensity ass
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 |
What the finished NCT01941537 record still lists
NCT01941537 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo Comparator is the first listed.
NCT01941537 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01941537's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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