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 | 17.0 |
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 |
Primary objective is to compare efficacy of BI 655066 versus ustekinumab at week 12, based on PASI90 response. |
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E.2.2 | Secondary objectives of the trial |
To compare efficacy of BI 655066 versus ustekinumab at week 12, based on PASI75, PASI100, PASI50, sPGA clear or almost clear, PASI reduction, and to compare efficacy at week 24, based on PASI90, and time to loss of PASI50 response. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Body Mass Index (BMI) = 18.5 and < 40 kg/m²
- Patients with stable moderate to severe chronic plaque-type psoriasis with or without psoriatic arthritis involving >/= 10% body surface area, with disease severity PASI >/= 12 and sPGA score of moderate and above (score of at least 3) at screening visit and visit 2 (randomisation), as assessed by the investigator
- Psoriasis disease duration of at least 6 months prior to screening, as assessed by the investigator
- Patients must be candidates for systemic psoriasis treatment or phototherapy, as assessed by the investigator
- Patients must be suitable candidates for ustekinumab (Stelara®) therapy as given in the local labeling
- Patient must give informed consent and sign an approved consent form prior to any study procedures in accordance with GCP and local legislation |
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E.4 | Principal exclusion criteria |
- Patients with guttatae, erythrodermic, or pustular psoriasis and patients with drug-induced psoriasis, as diagnosed by the investigator
- Evidence of current or previous clinically significant disease, medical condition other than psoriasis, or finding of the medical examination (including vital signs and ECG), that in the opinion of the investigator, would compromise the safety of the patient or the quality of the data. This criterion provides an opportunity for the investigator to exclude patients based on clinical judgment, even if other eligibility criteria are satisfied. (Psoriatic arthritis is not considered an exclusion criterion)
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders, or history of orthostatic hypotension, fainting spells or blackouts, that in the investigator's judgement, could jeopardize the safe conduct of the study.
- Clinically important acute or chronic infections including hepatitis and HIV. Clinically important acute or chronic infections including hepatitis and
HIV. With regards to tuberculosis the following applies:
• Have signs or symptoms suggestive of current active or latent TB upon
medical
history, physical examination and/or a chest radiograph (both posterioranterior
and lateral views, taken within 3 months prior to the first administration
of
study drug and read by a qualified radiologist).
• Have history of latent or active TB prior to screening, except for
patients who
have documentation of having completed an adequate treatment
regimen at least 6 months prior to the first administration of study
agent.
• Have positive IGRA testing (QuantiFERON-TB Gold) within 2 months
prior to
or during screening, in which active TB has not been ruled out, except
for
patients with history of latent TB and documentation of having
completed an
adequate treatment regimen at least 6 months prior to the first
administration of study agent.
- Have had a live vaccination >/= 12 weeks prior to randomisation (visit 2). Patients must agree not to receive a live vaccination during the study. No BCG vaccines should be given for one year prior to randomisation (visit 2), during the study and for one year after last administration of study drug (according to the Stelara® SPC).
- History of clinically significant hypersensitivity to a systemically administered biologic agent or its excipients
- History of malignancy in the past 5 years or suspicion of active malignant disease except treated cutaneous squamous cell or basal cell carcinoma
- Has received any therapeutic agent directly targeted to IL-12, IL-23 (including ustekinumab (Stelara®)
- Use of biologic agents within 12 weeks (infliximab, etanercept, adalimumab, other biologics) prior to treatment, systemic anti-psoriatic medications or phototherapy within 4 weeks prior to treatment, or topical anti-psoriasis medications within 2 weeks prior to treatment |
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E.5 End points |
E.5.1 | Primary end point(s) |
1: Achievement of >/= 90% reduction from baseline PASI score (PASI90) at week 12
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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) |
1: Achievement of >/=75% reduction from baseline in PASI score (PASI75) at week 12 and 24
2: Achievement of 100% reduction from baseline in PASI score (PASI100) at week 12
3: Achievement of >/= 50% reduction from baseline in PASI score (PASI50) at week 12
4: Achievement of PASI90 at week 24
5: Achievement of sPGA clear or almost clear at week 12
6: Percentage of PASI reduction from baseline at week 12
7: Time to loss of PASI50 response. This endpoint is calculated from the first treatment to first < 50% reduction of PASI score compared with baseline after the response has been achieved
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1: 24 weeks
2: 12 weeks
3: 12 weeks
4: 24 weeks
5: 12 weeks
6: 12 weeks
7: up to 48 weeks
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 16 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Canada |
Finland |
France |
Germany |
Norway |
Sweden |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 19 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 19 |