E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | |
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.1 |
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 |
|
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 |
The primary objectives of this trial are to assess the safety and efficacy of BI 655066 in comparison to placebo in patients with moderate to severe chronic plaque psoriasis.Following drug withdrawal the maintenance of response as well as the response to retreatment after relapse will be evaluated |
|
E.2.2 | Secondary objectives of the trial |
This study will also assess PK and emergence of anti-drug antibodies on efficacy and safety as well as how the use of BI 655066 may influence gene and protein expression levels and disease specific protein markers. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female patients. Woman of childbearing potential must be ready and willing to use highly effective methods of birth control per ICH M3 (R2) that result ina low failure rate of less than 1 percent per year when used consistently and correctly.
2. Age 18 ≥ years at screening
3. Have a diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) at least 6 months before the first administration of study drug. Duration of diagnosis may be reported by the patient.
4. Have stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis at both Screening and Baseline (Randomization);
Have an involved body surface area (BSA) ≥ 10% and
Have a Psoriasis Area and Severity Index (PASI) ≥ 12 and
Have a static Physician Global Assessment (sPGA) score of ≥ 3.
5. Must be a candidate for systemic therapy or phototherapy for psoriasis treatment, as assessed by the investigator
6. Signed and dated written informed consent prior to admission to the study and performance of any study procedures in accordance with GCP and local legislation
|
|
E.4 | Principal exclusion criteria |
1. Patients with nonplaque forms of psoriasis (including guttate, erythrodermic, or pustular); current drug-induced psoriasis (including a
new onset of psoriasis or an exacerbation of psoriasis from beta
blockers, calcium channel blockers, or lithium); active ongoing
inflammatory diseases other than psoriasis that might confound trial evaluations according to the investigators judgment
2. Previous exposure to BI 655066
3. Currently enrolled in another investigational study or less than 30
days (from screening) since completing another investigational study.
4. Use of any restricted medication as noted in Table 4.2.2.1:1 or any
drug considered likely to interfere with the safe conduct of the study
5. Major surgery performed within 12 weeks prior to randomization or planned within 12 months after screening (e.g. hip replacement, removal aneurysm, stomach ligation,).
6. Known chronic or relevant acute infections, such as HIV (Human Immunodeficiency Virus), \ viral hepatitis, or tuberculosis.
QuantiFERON® TB test or PPD skin test will be performed during
screening. Patients with a positive test result may participate in the
study if further work up (according to local practice/guidelines)
establishes conclusively that the patient has no evidence of active
tuberculosis. If presence of latent tuberculosis is estabilished, patients
who are at low risk of reactivation, defined by local guidelines and
investigator judgement, do not need to be treted with prophylactic anti-tuberculosis prior to or during the trial.
7. Any documented active or suspected malignancy or history of
malignancy within 5 years prior to screening, except appropriately
treated basal cell carcinoma or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix
8. Evidence of a current or previous disease (including chronic alcohol
or drug abuse), medical condition other than psoriasis, surgical
procedure (i.e., organ transplant), medical examination finding
(including vital signs and ECG), or laboratory value at the screening visit
outside the reference range that in the opinion of the Investigator, is
clinically significant and would make the study participant unable to
adhere to the protocol or to complete the trial, compromise the safety of
the patient, or compromise the quality of the data.
9. History of allergy/hypersensitivity to a systemically administered
biologic agent or its excipients
10. Women who are pregnant, nursing, or who plan to become
pregnant while in the trial
11. Previous enrolment in this trial
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
1: Achievement of ≥ 90% reduction from baseline PASI score (PASI90) at week 16
2: Achievement of an sPGA score of clear or almost clear at week 16
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
1: Achievement of 100% reduction from baseline PASI score (PASI100) at week 16
2: Achievement of a 75% reduction from baseline PASI score (PASI 75) at week 16
3: Achievement of an sPGA score of clear(0) at Week 16
4: Achievement of a Dermatology Life Quality Index (DLQI) score of 0 or 1 at Week 16
5: Achievement of an sPGA score of clear (0) or almost clear (1) at Week 52
6: Achievement of PASI 75 at Week 52
7: Achievement of PASI 90 at Week 52
8: Achievement of PASI 100 at Week 52
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1: Week 16
2: Week 16
3: Week 16
4: Week 16
5: week 52
6: week 52
7: week 52
8: week 52
|
|
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 | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
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) | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 27 |
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 |
Australia |
Belgium |
Canada |
Czech Republic |
France |
Germany |
Japan |
Korea, Republic of |
Netherlands |
United States |
|
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
|
|
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 | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 10 |