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ACTIVE NOT RECRUITING Phase 4

Risankizumab Long-term Remission Study

NCT04630652 · View on ClinicalTrials.gov ↗

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

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. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jaehwan Kim, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04630652 reports 3 study locations spanning 2 distinct geographic areas — top geographies include California, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04630652?

This trial is sponsored by Jaehwan Kim, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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