E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050576 |
E.1.2 | Term | Psoriasis vulgaris |
E.1.2 | System Organ Class | 100000004858 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
This study will evaluate brodalumab treatment in patients with moderate-to-severe psoriasis previously treated with anti-IL-17A with primary or secondary failure of treatment.
1. Percentage of patients achieving PASI75 or an absolute PASI ≤2 after 3 months. 2. Percentage of patients achieving PASI90 after 3 months.
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Formålet med studiet er at undersøge om patienter med moderat-til-svær psoriasis med tidligere svigt af anti-IL-17A har effekt af behandling med brodalumab.
• Undersøge andelen af patienter der opnår PASI75 eller absolut PASI≤2 efter 3 måneders behandling med brodalumab. • Undersøge andelen af patienter der opnår PASI90 efter 3 måneders behandling med brodalumab.
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E.2.2 | Secondary objectives of the trial |
1. Percentage of patients achieving PASI75 or an absolute PASI ≤2 after 6 and 12 months respectively. 2. Percentage of patients achieving PASI90 after 6 and 12 month respectively. 3. Percentage of patients achieving PASI100 after 3, 6, and 12 months respectively. 4. Changes in DLQI score after 3, 6, and 12 months treatment with brodalumab compared to DLQI score before treatment with brodlaumab. 5. Changes in inflammatory cytokines in blood after treatment and at each evaluation point compared to before treatment. 6. Changes in oxidative stress level after treatment and at each evaluation point compared to before treatment.
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• Undersøge andelen af patienter der opnår PASI75 eller absolut PASI≤2 efter 6 og 12 måneders behandling med brodalumab. • Undersøge andelen af patienter der opnår PASI90 efter 6 og 12 måneders behandling med brodalumab. • Undersøge andelen af patienter der opnår PASI100 efter 3, 6 og 12 måneders behandling med brodalumab. • Ændring i DLQI score efter 3, 6 og 12 måneders behandling med brodalumab i forhold til DLQI score inden behandling med brodalumab. • Ændring i inflammatoriske cytokiner i blodet efter behandling med brodalumab efter 4, 12, 26 og 52 uger i forhold til før behandlingen. • Ændring i oxidativt stress niveau efter behandling med brodalumab efter 4, 12, 26 og 52 uger i forhold til før behandlingen.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Patients must be > 18 • Have had moderate-to-severe plaque psoriasis (PASI>10) and a PASI≥6 at screening. • Be eligible to receive biological treatment • Have been treated with anti-IL-17A (ixekizumab and/or secukinumab) with treatment failure, defined as either: o Primary failure: <PASI50 after 3 months, or o Secondary failure: Initial response, but with subsequent loss of efficacy • Patients must have given their informed consent to the protocol and the clinical procedures • Be able to speak and understand Danish • No systemic or biological treatment for psoriasis in the last 4 weeks. • No concomitant methotrexate treatment
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1. Kvinder og mænd, som er mindst 18 år på screeningstidspunktet 2. Have haft moderat-til-svær psoriasis (PASI >10) og på screeningstidspunktet have PASI≥6 3. Være kandidater til biologisk behandling af deres psoriasis jf. medicinerrådets retningslinjer 4. Være behandlet med anti-IL-17A (secukinumab og/eller ixekizumab) for deres psoriasis og have fejlet på denne behandling, defineret som: - Primær failure: <PASI50 efter 3 måneder, eller - Sekundær failure: initial respons, men efterfølgende tab af effekt 5. Patienten skal være i stand til at kommunikere med forsøgslægen og opfylde de betingelser forsøget stiller samt afgive skriftligt samtykke, før forsøgsrelaterede procedurer kan påbegyndes. 6. Ikke have modtaget systemisk og/eller biologisk behandling for psoriasis de sidste 4 uger. 7. Der må ikke gives samtidig methotrexat
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E.4 | Principal exclusion criteria |
• Patients with clinically significant disorders • Patients with active TB/serious infections • Any psychiatric condition which in the Investigators opinion would preclude the patient from adhering to the protocol or completing the study per protocol. Patients with previous endogene depression. • Pregnancy • Nursing • Women of child-bearing potential must use effective contraception which includes IUD, oral, injected or implanted hormonal device, hormone patch, vaginal hormonal ring or sterilization. Occlusive cap or condom with spermicidal cream is not considered safe contraception. Post-menopausal women (>12 months of amenorrhea) are allowed not to use contraception. • Patients who have received any weakened vaccines 6 weeks prior to day 0 or who are planning to receive a weakened vaccine during the study • Allergy to brodalumab or any of the other ingredients in Kyntheum® • Active Crohn’s disease • Suicidal ideation and/or behavior
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1. Patienter med alvorlige kendte sygdomme som cancer (undtagen almindelig hudkræft og celleforandringer på livmoderhalsen) 2. Patienter med kendt aktiv tuberkulose eller alvorlige infektiøse sygdomme 3. Planlagt levende vaccine under forsøget eller 6 uger før baseline 4. Gravide eller ammende kvinder 5. Fertile kvinder skal anvende sikker prævention i hele forsøgsperioden og op til 16 uger efter behandlingsstop med brodalumab. Sikker prævention er p-piller, spiral, depotindsprøjtning af gestagen, hormonstav indsat under huden, hormonal vaginalring, depotplaster. Pessar eller kondom med sæddræbende creme anses ikke som sikker prævention. Sterilitet eller overgangsalder (> 12 måneder med amenoré) fritages for krav om prævention 6. Patienter med aktiv Crohns sygdom 7. Allergi over for brodalumab eller andre af de aktive stoffer i Kyntheum® 8. Selvmordstanker og/eller -handlinger 9. Enhver psykiatrisk lidelse som i investigatorernes vurdering vil udelukke patienten fra at vedholde protokollen eller udføre studiet efter protokollen 10. Patienter med tidligere endogen depression
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Percentage of patients achieving PASI75 or an absolute PASI ≤2 after 3 months. 2. Percentage of patients achieving PASI90 after 3 months.
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• Andelen af patienter der opnår PASI75 eller absolut PASI≤2 efter 3 måneders behandling med brodalumab. • Andelen af patienter der opnår PASI90 efter 3 måneders behandling med brodalumab.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Please see section E2 |
Se venligst sektion E2 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |