Trial · NCT04908475
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
NCT04908475, Phase 4, Completed, AbbVie; results first posted 2024-04-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT04908475. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04908475
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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
- NCT number
- NCT04908475
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 352 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Psoriasis
- Interventions
- Risankizumab, Apremilast
- First posted
- 2021-06-01
- Last updated
- 2024-04-30
- Other registries' IDs
- eudract:2020-005512-21
- Results first posted
- 2024-04-30
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 (Defined as at Least 90% Improvement in PASI From Baseline) in Intent to Treat Population at Week 16 (ITT_A) | Week 16 | The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with higher scores indicating more severe disease. |
| Primary | Percentage of Participants Achieving Static Physician Global Assessment (sPGA) 0 or 1 With at Least 2-grade Improvement From Baseline in Intent to Treat Population at Week 16 (ITT_A) | Week 16 | The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe). |
| Primary | Percentage of Participants Achieving PASI 90 in Intent to Treat Population for Apremilast Non-Responders at Week 52 (ITT_B_NR) | Week 52 | The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with higher scores indicating more severe disease. |
| Secondary | Percentage of Participants Achieving PASI 75 (Defined as at Least 75% Improvement in PASI From Baseline) in Intent to Treat Population at Week 16 (ITT_A) | Week 16 | The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with higher scores indicating more severe disease. |
| Secondary | Percentage of Participants Achieving PASI 75 in Intent to Treat Population for Apremilast Non-Responders at Week 52 (ITT_B_NR) | Week 52 | The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with higher scores indicating more severe disease. |
| Secondary | Percentage of Participants Achieving Static Physician Global Assessment (sPGA) 0 or 1 With at Least 2-grade Improvement From Baseline in Intent to Treat Population for Apremilast Non-Responders at Week 52 (ITT_B_NR) | Week 52 | The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe). |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 (Defined as at Least 90% Improvement in PASI From Baseline) in Intent to Treat Population at Week 16 (ITT_A) | Week 16 | ITT\_A Population: all participants randomized in Period A | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Achieving Static Physician Global Assessment (sPGA) 0 or 1 With at Least 2-grade Improvement From Baseline in Intent to Treat Population at Week 16 (ITT_A) | Week 16 | ITT\_A Population: all participants randomized in Period A. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Achieving PASI 90 in Intent to Treat Population for Apremilast Non-Responders at Week 52 (ITT_B_NR) | Week 52 | ITT\_B\_NR Population: participants randomized to APR at Baseline who failed to achieve PASI 75 at Week 16 and were re-randomized to APR or RZB in Period B. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving PASI 75 (Defined as at Least 75% Improvement in PASI From Baseline) in Intent to Treat Population at Week 16 (ITT_A) | Week 16 | ITT\_A Population: all participants randomized in Period A | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving PASI 75 in Intent to Treat Population for Apremilast Non-Responders at Week 52 (ITT_B_NR) | Week 52 | ITT\_B\_NR Population: participants randomized to APR at Baseline who failed to achieve PASI 75 at Week 16 and were re-randomized to APR or RZB in Period B. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Static Physician Global Assessment (sPGA) 0 or 1 With at Least 2-grade Improvement From Baseline in Intent to Treat Population for Apremilast Non-Responders at Week 52 (ITT_B_NR) | Week 52 | ITT\_B\_NR Population: participants randomized to APR at Baseline who failed to achieve PASI 75 at Week 16 and were re-randomized to APR or RZB in Period B. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 (Defined as at Least 90% Improvement in PASI From Baseline) in Intent to Treat Population at Week 16 (ITT_A) | Period A: APR | 5.1 | 95% Confidence Interval 2.3 to 8.0 | percentage of participants | |
| Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 (Defined as at Least 90% Improvement in PASI From Baseline) in Intent to Treat Population at Week 16 (ITT_A) | Period A: RZB | 55.9 | 95% Confidence Interval 47.0 to 64.9 | percentage of participants | |
| Percentage of Participants Achieving Static Physician Global Assessment (sPGA) 0 or 1 With at Least 2-grade Improvement From Baseline in Intent to Treat Population at Week 16 (ITT_A) | Period A: APR | 18.4 | 95% Confidence Interval 13.4 to 23.3 | percentage of participants | |
| Percentage of Participants Achieving Static Physician Global Assessment (sPGA) 0 or 1 With at Least 2-grade Improvement From Baseline in Intent to Treat Population at Week 16 (ITT_A) | Period A: RZB | 75.4 | 95% Confidence Interval 67.7 to 83.2 | percentage of participants | |
| Percentage of Participants Achieving PASI 90 in Intent to Treat Population for Apremilast Non-Responders at Week 52 (ITT_B_NR) | Period B: APR/APR, NR | 2.6 | 95% Confidence Interval 0.0 to 6.1 | percentage of participants | |
| Percentage of Participants Achieving PASI 90 in Intent to Treat Population for Apremilast Non-Responders at Week 52 (ITT_B_NR) | Period B: APR/RZB, NR | 72.3 | 95% Confidence Interval 62.7 to 81.9 | percentage of participants | |
| Percentage of Participants Achieving PASI 75 (Defined as at Least 75% Improvement in PASI From Baseline) in Intent to Treat Population at Week 16 (ITT_A) | Period A: APR | 18.8 | 95% Confidence Interval 13.8 to 23.8 | percentage of participants | |
| Percentage of Participants Achieving PASI 75 (Defined as at Least 75% Improvement in PASI From Baseline) in Intent to Treat Population at Week 16 (ITT_A) | Period A: RZB | 84.7 | 95% Confidence Interval 78.3 to 91.2 | percentage of participants | |
| Percentage of Participants Achieving PASI 75 in Intent to Treat Population for Apremilast Non-Responders at Week 52 (ITT_B_NR) | Period B: APR/APR, NR | 11.5 | 95% Confidence Interval 4.4 to 18.6 | percentage of participants | |
| Percentage of Participants Achieving PASI 75 in Intent to Treat Population for Apremilast Non-Responders at Week 52 (ITT_B_NR) | Period B: APR/RZB, NR | 83.1 | 95% Confidence Interval 75.1 to 91.2 | percentage of participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period A (Baseline to Week 16) | STARTED | Period A: APR | 234 | |
| Period A (Baseline to Week 16) | STARTED | Periods A/B: RZB/RZB | 118 | |
| Period A (Baseline to Week 16) | STARTED | Period B: APR/APR, NR | 0 | |
| Period A (Baseline to Week 16) | STARTED | Period B: APR/RZB, NR | 0 | |
| Period A (Baseline to Week 16) | STARTED | Period B: APR/APR, R | 0 | |
| Period A (Baseline to Week 16) | STARTED | Period B: APR/RZB, R | 0 | |
| Period A (Baseline to Week 16) | COMPLETED | Period A: APR | 216 | |
| Period A (Baseline to Week 16) | COMPLETED | Periods A/B: RZB/RZB | 118 | |
| Period A (Baseline to Week 16) | COMPLETED | Period B: APR/APR, NR | 0 | |
| Period A (Baseline to Week 16) | COMPLETED | Period B: APR/RZB, NR | 0 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events168
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | DIARRHOEA | Gastrointestinal disorders | Period A: APR | 47 | 234 | 50 |
| other | DIARRHOEA | Gastrointestinal disorders | Period A: RZB | 1 | 118 | 1 |
| other | DIARRHOEA | Gastrointestinal disorders | Period B: RZB/RZB | 0 | 116 | 0 |
| other | DIARRHOEA | Gastrointestinal disorders | Period B: APR/APR | 1 | 97 | 1 |
| other | DIARRHOEA | Gastrointestinal disorders | Period B: APR/RZB | 1 | 102 | 1 |
| other | DIARRHOEA | Gastrointestinal disorders | Period B: APR/APR/RZB | 0 | 48 | 0 |
| other | NAUSEA | Gastrointestinal disorders | Period A: APR | 41 | 234 | 45 |
| other | NAUSEA | Gastrointestinal disorders | Period A: RZB | 0 | 118 | 0 |
| other | NAUSEA | Gastrointestinal disorders | Period B: RZB/RZB | 2 | 116 | 2 |
| other | NAUSEA | Gastrointestinal disorders | Period B: APR/APR | 3 | 97 | 3 |
1 to 10 of 168Source ClinicalTrials.gov
See all 168 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Period A: APR | 0 | 234 |
| Total, all-cause mortality | Period A: RZB | 0 | 118 |
| Total, all-cause mortality | Period B: RZB/RZB | 0 | 116 |
| Total, all-cause mortality | Period B: APR/APR | 0 | 97 |
| Total, all-cause mortality | Period B: APR/RZB | 0 | 102 |
| Total, all-cause mortality | Period B: APR/APR/RZB | 0 | 48 |
| Total, other adverse events | Period A: APR | 101 | 234 |
| Total, other adverse events | Period A: RZB | 24 | 118 |
| Total, other adverse events | Period B: RZB/RZB | 36 | 116 |
| Total, other adverse events | Period B: APR/APR | 27 | 97 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37488811 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04908475
GET https://conductscience.org/api/trials/v1/NCT04908475/flow?page=2