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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: Active Phase 4 study of Psoriasis, sponsored by Jaehwan Kim.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Changes of regulatory immune cell proportions in total immune cells harvested from the skin biopsy tissues of subjects who have a reduction of 90% or more from baseline in the Psoriasis Area and Severity Index (PASI; range from 0 to 72) at week 12 and also maintain the 90% reduction in PASI at week 52.

Conditions Studied

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
Jaehwan Kim

1 total trials

What the registry record for NCT04630652 still lists

NCT04630652 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 489-participant average among 125 other Psoriasis trials with a reported enrollment target (96% lower).

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 a single indexed study location in 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.

Similar trials for Psoriasis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04630652's enrollment target sits among peer trials

20 107th of 125 higher than 16 of 125 other Psoriasis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Psoriasis 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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Source: ClinicalTrials.gov NCT04630652, the US trial registry maintained by the National Library of Medicine. NCT04630652 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.