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NCT04908475 · ClinicalTrials.gov registry record · Phase 4
Study of Subcutaneous Risankizumab Injection Compared to Oral Apremilast Tablets to Assess Change in Disease Activity And Adverse Events in Adult Participants With Moderate Plaque Psoriasis Who Are Candidates for Systemic Therapy
A Phase 4 study of Psoriasis, sponsored by AbbVie.
- Completed
- Registry status
- Phase 4
- Development phase
- 352
- Enrollment target
- 20
- Study locations
NCT04908475 is a Phase 4 study of Psoriasis that has completed, run by AbbVie. The registered enrollment target is 352 participants, below the 486-participant average among 125 other Psoriasis trials with a reported enrollment target (28% lower). The trial reports 20 study locations across 13 states.
The verdict
NCT04908475, a Phase 4 study of Psoriasis, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 352 participants
- Enrollment target
- 20
- Study locations
Study Summary
Psoriasis (PsO) is a chronic disease characterized by marked inflammation of the skin that results in thick, red, scaly plaques. This study will assess how safe and effective risankizumab is compared to apremilast in adult participants with moderate plaque psoriasis. Adverse events and change in disease symptoms will be monitored. Risankizumab (Skyrizi) and apremilast are approved drugs for the treatment of moderate to severe PsO. Approximately 330 participants with moderate plaque psoriasis (PsO) will be enrolled across approximately 55 sites globally. The study has 2 periods : Period A from Baseline to Week 16, and Period B, from Week 16 to Week 52. In Period A, participants will be randomly placed into 2 groups to receive either subcutaneous risankizumab or oral apremilast for 16 weeks. In Period B, participants who received apremilast in Period A will again be randomly assigned to 1 of the 2 groups to receive either risankizumab or apremilast for 36 weeks. At weeks 28 and 40, participants considered non-responders to apremilast based on their psoriasis score will be offered to receive risankizumab. There may be a higher burden for participants in this study compared to usual standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and questionnaires.
Conditions Studied
Interventions
- DRUG Risankizumab
- DRUG Apremilast
Study Locations (20)
Florida
- Florida Academic Centers Research and Education /ID# 229235 - Coral Gables
- Olympian Clinical Research - Largo /ID# 233792 - Largo
- Renstar Medical Research /ID# 228946 - Ocala
- ForCare Clinical Research /ID# 229135 - Tampa
Arizona
- Advanced Research Associates - Glendale /ID# 229266 - Glendale
- Alliance Dermatology and MOHs Center, PC /ID# 229224 - Phoenix
Michigan
- Michigan Center for Research Company /ID# 229136 - Clarkston
- Henry Ford Medical Center /ID# 229215 - Detroit
Nebraska
- Physician Research Collaboration, LLC /ID# 229225 - Lincoln
- Advanced Dermatology of the Midlands /ID# 229009 - Omaha
Ohio
- University Hospitals Case Medical Center /ID# 229240 - Cleveland
- Wright State Physicians - Fairborn /ID# 230051 - Fairborn
Alabama
- Total Skin and Beauty Dermatology Center /ID# 233793 - Birmingham
California
- UC Davis Health /ID# 229133 - Sacramento
Illinois
- Arlington Dermatology /ID# 228945 - Rolling Meadows
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 352 participants |
| Start Date | 2021-06-09 |
| Est. Completion | 2023-04-20 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04908475
The ClinicalTrials.gov registry entry for NCT04908475 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 352 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 486-participant average among 125 other Psoriasis trials with a reported enrollment target (28% lower). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Psoriasis appearing as the primary indexed condition, and to 2 interventions - of which Risankizumab is the first listed.
NCT04908475 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Florida, Arizona, Michigan.
Frequently Asked Questions
What is clinical trial NCT04908475 about?
NCT04908475 is a clinical study titled "Study of Subcutaneous Risankizumab Injection Compared to Oral Apremilast Tablets to Assess Change in Disease Activity And Adverse Events in Adult Participants With Moderate Plaque Psoriasis Who Are Candidates for Systemic Therapy". Psoriasis (PsO) is a chronic disease characterized by marked inflammation of the skin that results in thick, red, scaly plaques. This study will assess how safe and effective risankizumab is compared to apremilast in adult participants with moderate plaque psoriasis. Adverse events and change in dis...
What is the current status of trial NCT04908475?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 352 participants. The study started on 2021-06-09. Estimated completion is 2023-04-20.
What conditions does trial NCT04908475 study?
This clinical trial studies the following conditions: Psoriasis.
What interventions are being tested in trial NCT04908475?
The interventions under investigation include: Risankizumab (DRUG), Apremilast (DRUG).
Who is sponsoring clinical trial NCT04908475?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04908475 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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