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NCT03568162 · ClinicalTrials.gov registry record · Phase 2
Phase 2b Study to Evaluate the Efficacy and Safety of ISB 830 in Adults With Moderate to Severe Atopic Dermatitis
A Phase 2 study, sponsored by Ichnos Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 462
- Enrollment target
NCT03568162: Completed Phase 2 study, sponsored by Ichnos Sciences.
NCT03568162 is a Phase 2 study that has completed, run by Ichnos Sciences. The registered enrollment target is 462 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (247% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03568162, a Phase 2 study, has completed, sponsored by Ichnos Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 462 participants
- Enrollment target
Study Summary
Phase 2b, randomized, double-blinded, placebo-controlled dose range finding study to evaluate the efficacy, safety and tolerability of ISB 830 in adults with moderate to severe atopic dermatitis. The study will be conducted in 2 Parts, with dosing Groups 1-4 comprising Part 1, and dosing Groups 5-6 comprising Part 2. All subjects will receive open-label ISB 830 after a 16 week blinded treatment period.
Primary Outcome
In EASI, four disease characteristics of atopic dermatitis (AD) (erythema, edema/papulation, excoriation, and lichenification) are assessed for severity on a scale of 0 (absent), 1 (mild), 2 (moderate), 3 (severe). The scores are added up for each of the four body regions (Head and neck, trunk, arms, and legs). The assigned percentages of body surface area (BSA) for each section of the body are 10% for head and neck, 20% for arms, 30% for trunk, and 40% for legs. Each subtotal score is multiplie
Interventions
- DRUG ISB 830 - Part 1 Group 1
- DRUG ISB 830 - Part 1 Group 2
- DRUG ISB 830 - Part 1 Group 3
- DRUG Placebo - Part 1 Group 4
- DRUG ISB 830 - Part 2 Group 5
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 462 participants |
| Start Date | 2018-05-31 |
| Est. Completion | 2021-08-03 |
| Phase | Phase 2 |
What the finished NCT03568162 record still lists
NCT03568162 is an interventional study that assigns participants to a tested intervention. The registered 462 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (247% higher).
The record links to 0 conditions, and to 5 interventions - of which ISB 830 - Part 1 Group 1 is the first listed.
NCT03568162 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03568162 about?
NCT03568162 is a clinical study titled "Phase 2b Study to Evaluate the Efficacy and Safety of ISB 830 in Adults With Moderate to Severe Atopic Dermatitis". Phase 2b, randomized, double-blinded, placebo-controlled dose range finding study to evaluate the efficacy, safety and tolerability of ISB 830 in adults with moderate to severe atopic dermatitis. The study will be conducted in 2 Parts, with dosing Groups 1-4 comprising Part 1, and dosing Groups 5-6 ...
What is the current status of trial NCT03568162?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 462 participants. The study started on 2018-05-31. Estimated completion is 2021-08-03.
What interventions are being tested in trial NCT03568162?
The interventions under investigation include: ISB 830 - Part 1 Group 1 (DRUG), ISB 830 - Part 1 Group 2 (DRUG), ISB 830 - Part 1 Group 3 (DRUG), Placebo - Part 1 Group 4 (DRUG), ISB 830 - Part 2 Group 5 (DRUG).
Who is sponsoring clinical trial NCT03568162?
This trial is sponsored by Ichnos Sciences, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03568162's enrollment target sits among peer trials
462 82nd of 2000 higher than 1,919 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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