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
Public ClinicalTrials.gov record NCT04908475. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 4 Multicenter, Randomized, Open-label, Efficacy Assessor-blinded Study of Risankizumab Compared to Apremilast for the Treatment of Adult Subjects With Moderate Plaque Psoriasis Who Are Candidates for Systemic Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04908475
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 352 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 9, 2021 (Actual)
- Primary completion
- Apr 20, 2023 (Actual)
- Completion
- Apr 20, 2023 (Actual)
- Last update posted
- Apr 30, 2024
2021 – 2023
United States locations
- U.S. sites
- 26
- U.S. states
- 16
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Total Skin and Beauty Dermatology Center /ID# 233793 | Birmingham | Alabama | 35205 | — |
| Advanced Research Associates - Glendale /ID# 229266 | Glendale | Arizona | 85308 | — |
| Alliance Dermatology and MOHs Center, PC /ID# 229224 | Phoenix | Arizona | 85032 | — |
| UC Davis Health /ID# 229133 | Sacramento | California | 95816-3300 | — |
| Florida Academic Centers Research and Education /ID# 229235 | Coral Gables | Florida | 33134 | — |
| Olympian Clinical Research - Largo /ID# 233792 | Largo | Florida | 33770 | — |
| Renstar Medical Research /ID# 228946 | Ocala | Florida | 34470 | — |
| ForCare Clinical Research /ID# 229135 | Tampa | Florida | 33613-1244 | — |
| Arlington Dermatology /ID# 228945 | Rolling Meadows | Illinois | 60008 | — |
| Dawes Fretzin, LLC /ID# 229010 | Indianapolis | Indiana | 46256 | — |
| Epiphany Dermatology of Kansas LLC /ID# 229221 | Overland Park | Kansas | 66210 | — |
| DermAssociates, LLC /ID# 229016 | Rockville | Maryland | 20850 | — |
| Michigan Center for Research Company /ID# 229136 | Clarkston | Michigan | 48346 | — |
| Henry Ford Medical Center /ID# 229215 | Detroit | Michigan | 48202-3046 | — |
| MediSearch Clinical Trials /ID# 229269 | Saint Joseph | Missouri | 64506 | — |
| Physician Research Collaboration, LLC /ID# 229225 | Lincoln | Nebraska | 68516 | — |
| Advanced Dermatology of the Midlands /ID# 229009 | Omaha | Nebraska | 68144-1105 | — |
| Psoriasis Treatment Center of Central New Jersey /ID# 228943 | East Windsor | New Jersey | 08520 | — |
| University Hospitals Case Medical Center /ID# 229240 | Cleveland | Ohio | 44106 | — |
| Wright State Physicians - Fairborn /ID# 230051 | Fairborn | Ohio | 45324-2640 | — |
| Oregon Dermatology and Research Center /ID# 233462 | Portland | Oregon | 97210 | — |
| Arlington Research Center, Inc /ID# 229264 | Arlington | Texas | 76011 | — |
| Bellaire Dermatology Associates /ID# 230118 | Bellaire | Texas | 77401 | — |
| Center for Clinical Studies - Houston (Binz) /ID# 229263 | Houston | Texas | 77004-8097 | — |
| Center for Clinical Studies - Houston (Binz) /ID# 229272 | Houston | Texas | 77004-8097 | — |
| Premier Clinical Research /ID# 229220 | Spokane | Washington | 99202 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 28 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04908475, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 30, 2024 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04908475 live on ClinicalTrials.gov.