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NCT04999839 · ClinicalTrials.gov registry record · Phase 2
Study of NDI-034858 in Participants With Moderate to Severe Plaque Psoriasis
A Phase 2 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 2
- Development phase
- 259
- Enrollment target
NCT04999839: Completed Phase 2 study, sponsored by Takeda.
NCT04999839 is a Phase 2 study that has completed, run by Takeda. The registered enrollment target is 259 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04999839, a Phase 2 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 259 participants
- Enrollment target
Study Summary
This is a Phase 2b, randomized, multicenter, double-blind, placebo-controlled, multiple-dose study designed to evaluate the efficacy, safety, and tolerability of NDI-034858 in participants with moderate to severe plaque psoriasis. This study will also evaluate the plasma concentrations of NDI-034858 and explore the immune response to NDI-034858 in participants with moderate to severe plaque psoriasis.
Primary Outcome
The PASI quantifies the severity of a participant's psoriasis based on both "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of
Interventions
- OTHER Placebo
- DRUG NDI-034858 study drug
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 259 participants |
| Start Date | 2021-08-11 |
| Est. Completion | 2022-09-12 |
| Phase | Phase 2 |
What the finished NCT04999839 record still lists
NCT04999839 is an interventional study that assigns participants to a tested intervention. The registered 259 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 (95% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04999839 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04999839 about?
NCT04999839 is a clinical study titled "Study of NDI-034858 in Participants With Moderate to Severe Plaque Psoriasis". This is a Phase 2b, randomized, multicenter, double-blind, placebo-controlled, multiple-dose study designed to evaluate the efficacy, safety, and tolerability of NDI-034858 in participants with moderate to severe plaque psoriasis. This study will also evaluate the plasma concentrations of NDI-034858...
What is the current status of trial NCT04999839?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 259 participants. The study started on 2021-08-11. Estimated completion is 2022-09-12.
What interventions are being tested in trial NCT04999839?
The interventions under investigation include: Placebo (OTHER), NDI-034858 study drug (DRUG).
Who is sponsoring clinical trial NCT04999839?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04999839's enrollment target sits among peer trials
259 212th of 2000 higher than 1,789 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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