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NCT04630652 · ClinicalTrials.gov registry record · Phase 4

Risankizumab Long-term Remission Study

A Phase 4 study of Psoriasis, sponsored by Jaehwan Kim.

Active
Registry status
Phase 4
Development phase
20
Enrollment target
3
Study locations

NCT04630652 is a Phase 4 study of Psoriasis that is active but no longer recruiting, run by Jaehwan Kim. The registered enrollment target is 20 participants, below the 489-participant average among 125 other Psoriasis trials with a reported enrollment target (96% lower). The trial reports 3 study locations across 2 states.

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The verdict

NCT04630652, a Phase 4 study of Psoriasis, is active but no longer recruiting, sponsored by Jaehwan Kim.

ACTIVE NOT RECRUITING
Registry status
Phase 4
Development phase
20 participants
Enrollment target
3
Study locations

Study Summary

Although the newly developed biologics (drugs derived from living cells cultured in a laboratory) are highly effective in controlling psoriasis, all the biologics should be continuously injected to suppress recurrence of the disease. In this regard, the observation in the phase II clinical trial conducted by us (Laboratory for Investigative Dermatology at the Rockefeller University) was groundbreaking that just a single dose of anti-IL-23p19 antibody (risankizumab, trade name: Skyrizi, study drug in this clinical trial) administration produced disease clearance up to 66 weeks in 46% (6 of 13) of patients. However, there is a lack of understanding about immune regulation in human skin induced by anti-IL-23p19 antibody injection, and there is a need to conduct a psoriasis clinical trial for single-cell sequencing immune cells in human psoriasis skin before and after anti-IL-23p19 antibody administration, and to correlate regulatory immune cell alterations with clinical disease progression. The overall objective of the clinical trial is to study regulatory immune cell alterations induced by anti-IL-23p19 antibody administration in psoriasis patients who achieve long-term disease clearance off drugs.

Conditions Studied

Psoriasis

Interventions

  • DRUG Risankizumab-Rzaa
  • PROCEDURE Punch biopsies of the skin at baseline visit
  • PROCEDURE Punch biopsies of the skin at week 28 visit

Study Locations (3)

California

  • VA Northern California Health Care System - Sacramento
  • University of California Davis Medical Center - Sacramento

New York

  • The Rockefeller Univesity - New York

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2021-04-07
Est. Completion 2027-07-28
Phase Phase 4

Sponsor

Jaehwan Kim

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04630652

The ClinicalTrials.gov registry entry for NCT04630652 describes a study currently listed as active not recruiting, categorized as Phase 4. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 489-participant average among 125 other Psoriasis trials with a reported enrollment target (96% lower). The listed sponsor is Jaehwan Kim, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Psoriasis appearing as the primary indexed condition, and to 3 interventions - of which Risankizumab-Rzaa is the first listed.

NCT04630652 reports 3 study locations spanning 2 distinct geographic areas - top geographies include California, New York.

Frequently Asked Questions

What is clinical trial NCT04630652 about?

NCT04630652 is a clinical study titled "Risankizumab Long-term Remission Study". Although the newly developed biologics (drugs derived from living cells cultured in a laboratory) are highly effective in controlling psoriasis, all the biologics should be continuously injected to suppress recurrence of the disease. In this regard, the observation in the phase II clinical trial con...

What is the current status of trial NCT04630652?

This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2021-04-07. Estimated completion is 2027-07-28.

What conditions does trial NCT04630652 study?

This clinical trial studies the following conditions: Psoriasis.

What interventions are being tested in trial NCT04630652?

The interventions under investigation include: Risankizumab-Rzaa (DRUG), Punch biopsies of the skin at baseline visit (PROCEDURE), Punch biopsies of the skin at week 28 visit (PROCEDURE).

Who is sponsoring clinical trial NCT04630652?

This trial is sponsored by Jaehwan Kim, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04630652 being conducted?

This trial has 3 study locations across California, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.