Phase 4
Completed N=210
A Trial Comparing the Efficacy of Subcutaneous Injections of Brodalumab to Oral Administrations of Fumaric Acid Esters in Adults With Moderate to Severe Plaque Psoriasis
Source: ClinicalTrials.gov NCT03331835 ↗Enrolled (actual)
210
Serious AEs
1.9%
Results posted
Feb 2020
Primary outcomePrimary: Having Least 75% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 75 Response) From Baseline at Week 24 — 85; 40 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 This can indicate results are unpublished — a known publication-bias signal.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 primary objective is to demonstrate added benefit of brodalumab versus a selected systemic comparator in treatment of moderate to severe plaque psoriasis in Germany in subjects who have not previously received systemic treatment for psoriasis.
Fumaric acid esters have been selected as the comparator because it is an established systemic treatment of psoriasis in Germany.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Having Least 75% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 75 Response) From Baseline at Week 24 |
85; 40 | <0.001 sig |
| PRIMARY Static Physician's Global Assessment (sPGA) Scale Score of 0 or 1 at Week 24 |
68; 21 | <0.001 sig |
| SECONDARY Having Least 90% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 90 Response) From Baseline at Week 24 |
69; 23 | <0.001 sig |
| SECONDARY Having 100% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 100 Response) From Baseline at Week 24 |
42; 9 | <0.001 sig |
| SECONDARY Change From Baseline at Week 24 in PASI Score |
-15.69; -12.62 | <0.001 sig |
| SECONDARY Percent Change From Baseline in PASI Score at Week 24 |
-90.03; -73.67 | <0.001 sig |
| SECONDARY Change From Baseline at Week 24 in Affected Body Surface Area (BSA) |
-20.82; -11.91 | <0.001 sig |
| SECONDARY Psoriasis Symptom Inventory (PSI) Responder at Week 24 (Total Score ≤ 8, With no Item Scores > 1) |
15; 13 | — |
| SECONDARY PSI Total Score of 0 at Week 24 |
5; 3 | — |
| SECONDARY Number of Symptom-free Days From Randomisation to Week 24 |
0.44; 0.42 | — |
| SECONDARY Burden of Symptoms |
6.00; 10.92 | <0.001 sig |
| SECONDARY Change From Baseline at Week 24 in Dermatology Life Quality Index (DLQI) Total Score |
-16.67; -14.10 | 0.004 sig |
| SECONDARY DLQI Total Score of 0 or 1 at Week 24 |
70; 27 | <0.001 sig |
Eligibility Criteria
Main Criteria for Inclusion:
- Men or women ≥18 years of age at the time of screening.
- Subjects with chronic plaque type psoriasis diagnosed at least 6 months before randomisation.
- Subjects with moderate to severe plaque psoriasis in whom topical therapy is not adequate and who are candidates for systemic therapy, defined at randomisation by PASI 10, affected BSA >10%, and DLQI >10.
- Subject has no known history of active tuberculosis.
- Subject has a negative test for tuberculosis taken at screening (negative Quantiferon test).
- Subject and/or subject's designee is/are capable of administering subcutaneous injections.
Main Criteria for Exclusion:
- Previous or current systemic treatment of plaque psoriasis or known contraindication for systemic therapy.
- Previous or current PUVA (psoralens and ultraviolet A) therapy.
- Washouts and non-permitted drugs:
- Have received phototherapy (UVA light therapy without psoralens, UVB light therapy, excimer laser, tanning beds etc. within 4 weeks of baseline, or
- Have had topical psoriasis treatment within 2 weeks of baseline (exceptions: bland emollients without urea or beta or alpha hydroxy acids)
- Have received any biologic immune modulating treatments used for indication other than psoriasis within 4 weeks of baseline or within a period of 5 half-lives of the IMP, whichever is longer
- Have received any other systemic immune modulating treatment (including but not limited to oral retinoids, methotrexate, calcineurin inhibitors, oral or parenteral corticosteroids etc. used for indications other than psoriasis) within 4 weeks of baseline or within a period of 5 half-lives of the IMP, whichever is longer.
- Subjects with any of the following laboratory abnormalities at screening:
- Leukocyte cell count below 3×10^9/L or lymphocyte count below 0.7×10^9/L
- Aspartate aminotransferase (AST) or alanine transferase (ALT) > 2× ULN (upper level of normal limit)
- Absolute neutrophil count ULN.
- History of depressive disorder within the last 2 years including current antidepressive treatment.
- Subjects with a history of suicidal behaviour (suicide attempt).
- Any suicidal ideation of severity 4 or 5 based on the eC-SSRS questionnaire at screening.
- A PHQ-8 score of ≥10 corresponding to moderate to severe depression at screening.
Data sourced from ClinicalTrials.gov (NCT03331835). 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.