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NCT03858634 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Chronic Pruritic Diseases
A Phase 2 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 2
- Development phase
- 58
- Enrollment target
NCT03858634: Completed Phase 2 study, sponsored by Genentech.
NCT03858634 is a Phase 2 study that has completed, run by Genentech. The registered enrollment target is 58 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03858634, a Phase 2 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 58 participants
- Enrollment target
Study Summary
Participants with diseases characterized by chronic pruritus experiencing moderate to severe pruritus will be enrolled in this pilot Phase 2 study. The diseases characterized by chronic pruritus investigated in this pilot study currently include chronic idiopathic urticaria (CIU), chronic idiopathic pruritus (CIP), lichen planus (LP), lichen simplex chronicus (LSC) and plaque psoriasis (PPs).
Primary Outcome
WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement.
Interventions
- DRUG Placebo
- DRUG KPL-716
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2019-05-29 |
| Est. Completion | 2020-06-08 |
| Phase | Phase 2 |
What the finished NCT03858634 record still lists
NCT03858634 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03858634 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03858634 about?
NCT03858634 is a clinical study titled "A Study to Assess the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Chronic Pruritic Diseases". Participants with diseases characterized by chronic pruritus experiencing moderate to severe pruritus will be enrolled in this pilot Phase 2 study. The diseases characterized by chronic pruritus investigated in this pilot study currently include chronic idiopathic urticaria (CIU), chronic idiopathi...
What is the current status of trial NCT03858634?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2019-05-29. Estimated completion is 2020-06-08.
What interventions are being tested in trial NCT03858634?
The interventions under investigation include: Placebo (DRUG), KPL-716 (DRUG).
Who is sponsoring clinical trial NCT03858634?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03858634's enrollment target sits among peer trials
58 1135th of 2000 higher than 860 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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