Phase 3
Completed N=120
A Study to Assess the Efficacy of Risankizumab Compared to FUMADERM® in Subjects With Moderate to Severe Plaque Psoriasis Who Are Naïve to and Candidates for Systemic Therapy
Source: ClinicalTrials.gov NCT03255382 ↗Enrolled (actual)
120
Serious AEs
2.6%
Results posted
Sep 2019
Primary outcomePrimary: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI90) at Week 24 — 10.0; 83.3 percentage of participants — p=< 0.001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to compare the efficacy and safety of subcutaneous (SC) risankizumab and oral FUMADERM provided as study medication in participants with moderate to severe plaque psoriasis who are naïve to and candidates for systemic therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI90) at Week 24 |
10.0; 83.3 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 4 |
6.7; 53.3 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 8 |
28.3; 91.7 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 12 |
46.7; 100 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 16 |
60.0; 100 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 20 |
63.3; 100 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 24 |
53.3; 100 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 4 |
3.3; 13.3 | 0.047 sig |
| SECONDARY Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 8 |
8.3; 75.0 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 12 |
20.0; 86.7 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16 |
26.7; 93.3 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 20 |
38.3; 95.0 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 24 |
33.3; 98.3 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 4 |
0; 1.7 | 0.392 |
| SECONDARY Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 8 |
1.7; 38.3 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 12 |
5.0; 61.7 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 16 |
11.7; 76.7 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 20 |
16.7; 83.3 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 4 |
0; 0 | 0.991 |
| SECONDARY Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 8 |
1.7; 5.0 | 0.323 |
| SECONDARY Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 12 |
1.7; 23.3 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 16 |
1.7; 35.0 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 20 |
6.7; 48.3 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 24 |
5.0; 50.0 | < 0.001 sig |
| SECONDARY Psoriasis Area and Severity Index (PASI): Change From Baseline to Week 4 |
-2.37; -9.56 | < 0.001 sig |
| SECONDARY PASI: Change From Baseline to Week 8 |
-5.61; -15.18 | < 0.001 sig |
| SECONDARY PASI: Change From Baseline to Week 12 |
-7.69; -16.49 | < 0.001 sig |
| SECONDARY PASI: Change From Baseline to Week 16 |
-9.11; -16.89 | < 0.001 sig |
| SECONDARY PASI: Change From Baseline to Week 20 |
-9.46; -17.35 | < 0.001 sig |
| SECONDARY PASI: Change From Baseline to Week 24 |
-9.31; -17.69 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 4 |
3.3; 33.3 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 8 |
15.0; 81.7 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 12 |
33.3; 90.0 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 16 |
31.7; 91.7 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 20 |
48.3; 93.3 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 24 |
38.3; 93.3 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving sPGA Score of Clear at Week 4 |
0; 1.7 | 0.392 |
| SECONDARY Percentage of Participants Achieving sPGA Score of Clear at Week 8 |
1.7; 10.0 | 0.048 sig |
| SECONDARY Percentage of Participants Achieving sPGA Score of Clear at Week 12 |
3.3; 21.7 | 0.001 sig |
| SECONDARY Percentage of Participants Achieving sPGA Score of Clear at Week 16 |
3.3; 36.7 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving sPGA Score of Clear at Week 20 |
6.7; 48.3 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving sPGA Score of Clear at Week 24 |
5.0; 51.7 | < 0.001 sig |
| SECONDARY Percentage of Participants With Psoriasis Symptoms Scale (PSS) Score of 0 at Week 16 |
5.0; 25.0 | 0.001 sig |
| SECONDARY Percentage of Participants With PSS Score of 0 at Week 24 |
3.3; 41.7 | < 0.001 sig |
| SECONDARY PSS Total Score: Change From Baseline to Week 16 |
-5.5; -8.7 | < 0.001 sig |
| SECONDARY PSS Total Score: Change From Baseline to Week 24 |
-5.6; -9.5 | < 0.001 sig |
| SECONDARY Summary of Patient Benefit Index (PBI) at Week 16 |
1.970; 3.118 | < 0.001 sig |
| SECONDARY Summary of PBI at Week 24 |
1.997; 3.316 | < 0.001 sig |
| SECONDARY Clinical Severity of Nail Psoriasis (NAPPA-CLIN) Total Score: Change From Baseline to Week 16 |
-0.4; -2.7 | < 0.001 sig |
| SECONDARY NAPPA-CLIN Total Score: Change From Baseline to Week 24 |
-0.7; -3.7 | < 0.001 sig |
| SECONDARY Palmoplantar Psoriasis Severity Index (PPASI): Change From Baseline to Week 16 |
-0.76; -1.04 | 0.352 |
| SECONDARY PPASI: Change From Baseline to Week 24 |
-0.87; -1.17 | 0.315 |
| SECONDARY Body Surface Area (BSA) Affected by Psoriasis: Change From Baseline to Week 4 |
-0.3; -5.2 | < 0.001 sig |
| SECONDARY BSA Affected by Psoriasis: Change From Baseline to Week 8 |
-3.5; -12.8 | < 0.001 sig |
| SECONDARY BSA Affected by Psoriasis: Change From Baseline to Week 12 |
-6.0; -16.2 | < 0.001 sig |
| SECONDARY BSA Affected by Psoriasis: Change From Baseline to Week 16 |
-8.2; -18.0 | < 0.001 sig |
| SECONDARY BSA Affected by Psoriasis: Change From Baseline to Week 20 |
-9.7; -19.3 | < 0.001 sig |
| SECONDARY BSA Affected by Psoriasis: Change From Baseline to Week 24 |
-9.8; -19.8 | < 0.001 sig |
| SECONDARY Short Form Health Survey 36, Version 2 (SF-36 V2) Physical Component Summary (PCS) Score: Change From Baseline to Week 16 |
2.87; 7.36 | 0.002 sig |
| SECONDARY SF-36 V2 PCS Score: Change From Baseline to Week 24 |
3.68; 8.31 | < 0.001 sig |
| SECONDARY SF-36 V2 Mental Component Summary (MCS) Score: Change From Baseline: to Week 16 |
4.20; 10.86 | < 0.001 sig |
| SECONDARY SF-36 V2 MCS Score: Change From Baseline to Week 24 |
3.56; 11.41 | < 0.001 sig |
| SECONDARY Patient's Global Assessment (PtGA): Change From Baseline to Week 16 |
-1.0; -1.9 | < 0.001 sig |
| SECONDARY PtGA: Change From Baseline to Week 24 |
-1.0; -2.0 | < 0.001 sig |
| SECONDARY Hospital Anxiety & Depression Scale (HADS) Total Score-Anxiety: Change From Baseline to Week 16 |
-2.2; -4.3 | < 0.001 sig |
| SECONDARY HADS Total Score-Anxiety: Change From Baseline to Week 24 |
-1.8; -4.0 | < 0.001 sig |
| SECONDARY HADS Total Score-Depression: Change From Baseline to Week 16 |
-1.8; -4.9 | < 0.001 sig |
| SECONDARY HADS Total Score-Depression: Change From Baseline to Week 24 |
-1.7; -4.8 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16 |
10.0; 48.3 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving DLQI Score of 0 or 1 at Week 24 |
10.0; 66.7 | < 0.001 sig |
| SECONDARY DLQI Total Score: Change From Baseline to Week 16 |
-9.7; -17.0 | < 0.001 sig |
| SECONDARY DLQI: Change From Baseline to Week 24 |
-11.2; -18.8 | < 0.001 sig |
| SECONDARY Psoriasis Scalp Severity Index (PSSI): Change From Baseline at Week 16 |
-14.6; -21.2 | < 0.001 sig |
| SECONDARY PSSI: Change From Baseline at Week 24 |
-13.9; -22.0 | < 0.001 sig |
| SECONDARY European Quality of Life 5 Dimensions (EQ-5D-5L) Total Score: Change From Baseline to Week 16 |
0.083; 0.171 | < 0.001 sig |
| SECONDARY EQ-5D-5L Total Score: Change From Baseline to Week 24 |
0.106; 0.165 | 0.002 sig |
| SECONDARY EQ-5D-5L Visual Analog Scale (VAS): Change From Baseline to Week 16 |
11.0; 26.0 | < 0.001 sig |
| SECONDARY EQ-5D-5L VAS: Change From Baseline to Week 24 |
11.6; 28.4 | < 0.001 sig |
| SECONDARY Nail Psoriasis Severity Index (NAPSI): Change From Baseline to Week 16 |
-2.2; -13.6 | < 0.001 sig |
| SECONDARY NAPSI: Change From Baseline to Week 24 |
-4.4; -18.1 | < 0.001 sig |
| SECONDARY Participants With Baseline NAPSI ˃0: Change From Baseline to Week 16 |
-4.2; -21.4 | < 0.001 sig |
| SECONDARY Participants With Baseline NAPSI ˃0: Change From Baseline to Week 24 |
-6.0; -27.5 | < 0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Have a diagnosis of chronic plaque psoriasis for at least 6 months before the first administration of study drug. Duration since diagnosis may be reported by the participant
- Participant has stable moderate to severe plaque psoriasis (body surface area [BSA] >10, Psoriasis Area and Severity Index [PASI] >10, and Dermatology Quality of Life Index [DLQI] >10) with or without psoriatic arthritis at Baseline
- Must be naïve to and candidate for systemic therapy, as assessed by the investigator
- Participant has an inadequate response, intolerance or contraindication to topical psoriasis treatment
Exclusion Criteria
- Participants with non-plaque forms of psoriasis
- Participant has previously received systemic therapy for psoriasis, whether biologic or non-biologic or photochemotherapy
- Active systemic infection during the last 2 weeks (exception: common cold) prior to screening.
- Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix
- Participant has any condition or contraindication to Fumaderm that would preclude the patient's participation in the present study
Data sourced from ClinicalTrials.gov (NCT03255382). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.