E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with moderate to severe chronic plaque psoriasis. |
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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 | PT |
E.1.2 | Classification code | 10037153 |
E.1.2 | Term | Psoriasis |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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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 |
Safety of BI 655066 during open-label, long-term treatment |
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E.2.2 | Secondary objectives of the trial |
Assess the long term efficacy BI 655066 in patients with moderate to severe chronic plaque psoriasis. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Patients with moderate to severe chronic plaque psoriasis, who have successfully completed the preceding trial, 1311.2. Successful completion of preceding trial is defined as either of the following:
a. Completion of the entire follow up period, thus reaching EOS visit.
b. Loss of response, defined as decrease in response to <PASI50 at any time from week 24.
- 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 who experienced any drug related Serious Adverse Event in the preceding trial
-Patients who have developed guttate, erythrodermic or pustular psoriasis or drug-induced psoriasis (as diagnosed by the investigator), during the preceding trial 1311.2
-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
-Known clinically important acute or chronic infections including hepatitis, HIV and tuberculosis (including latent tuberculosis), or a positive interferon gamma release assay (IGRA) testing for tuberculosis (if available at visit 1)
-Patients who have developed malignancy, or suspicion of active malignant disease during the preceding trial 1311.2 (except treated cutaneous squamous cell or basal cell carcinoma or carcinoma in situ of the cervix that have been adequately treated). |
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E.5 End points |
E.5.1 | Primary end point(s) |
1: The primary efficacy endpoint is achievement of a greater than or equal to 90% reduction in PASI score from
baseline (i.e., achieving PASI 90) at the week 12 visit. Baseline PASI for this study is defined
as the baseline PASI for the 1311.2 study.
2: Occurrence of AE
3: Occurrence of drug related AEs
4: Occurrence of SAEs
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1: 12 Weeks
2: 4.5 years
3: 4.5 years
4: 4.5 years
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E.5.2 | Secondary end point(s) |
1: Achievement of PASI 50 at the week 12 visit:
2: Proportion of patients achieving an sPGA of clear or almost clear
3: Achievement of PASI 75 at the week 12 visit:
4: Achievement of PASI 100at the week 12 visit:
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1: 12 Weeks
2: 12 Weeks
3: 12 Weeks
4: 12 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 | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
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 | Information not present in EudraCT |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 17 |
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 | 4 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 16 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 16 |