E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Generalized Pustular Psoriasis |
|
E.1.1.1 | Medical condition in easily understood language |
Generalized Pustular Psoriasis |
|
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 | 10037159 |
E.1.2 | Term | Psoriasis pustular |
E.1.2 | System Organ Class | 100000004858 |
|
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the long-term safety and efficacy of BI 655130 in patients with GPP, who have
completed previous BI 655130 trials and are qualified for entry in this trial |
|
E.2.2 | Secondary objectives of the trial |
The primary endpoint is the occurrence of treatment emergent adverse events (TEAEs) up to
week 252 of maintenance treatment |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female patients who have completed the treatment period without premature
discontinuation in the previous BI 655130 trial (1368-0013 or 1368-0027) and are willing
and able to continue treatment in the current trial
2. Women of childbearing potential must be ready and able to use highly effective methods
of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year
when used consistently and correctly. A list of contraception methods meeting these
criteria is provided in Section 4.2.2.3 as well as in the patient information. Note: A
woman is considered of childbearing potential, i.e. fertile, following menarche and until
becoming postmenopausal unless permanently sterile. Permanent sterilisation methods
include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tubal ligation
is not a method of permanent sterilization. A postmenopausal state is defined as no
menses for 12 months without an alternative medical cause.
3. Signed and dated written informed consent for the current trial 1368-0025, in accordance
with ICH-GCP and local legislation prior to admission to the current trial |
|
E.4 | Principal exclusion criteria |
. Evidence of flare symptoms of moderate/severe intensity at screening
2. Treatment with any restricted medication as specified in Table 4.2.2.1:1, or any drugs
considered by the investigator likely to interfere with the safe conduct of the study since
the last visit of the previous BI 651330 trial and during the screening period for the
current trial
3. Severe, progressive, or uncontrolled hepatic disease, defined as >3-fold Upper Limit of
Normal (ULN) elevation in AST or ALT or alkaline phosphatase, or >2-fold ULN
elevation in total bilirubin.
4. Patients with congestive heart disease, as assessed by the investigator.
5. Relevant chronic or acute infections including human immunodeficiency virus (HIV) or
viral hepatitis. A patient can be re-screened if the patient was treated and is cured from
acute infection.
6. Active or Latent tuberculosis (TB):
If the result of QuantiFERON® TB test is positive, the patient may participate in the
current study if further work up (according to local practice/guidelines) establishes
conclusively that the patient has no evidence of active TB. Active TB patients must be
excluded. If presence of latent tuberculosis is established, then treatment should be
initiated and maintained according to local country guidelines.
If QuantiFERON® TB test provides indeterminate results after repeat testing: A
tuberculin skin test reaction ≥10mm (≥5mm if receiving ≥15mg/d prednisone or its
equivalent).
7. History of allergy/hypersensitivity to a systemically administered trial medication agent
or its excipients.
8. Any documented active or suspected malignancy at screening, except appropriately
treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ
carcinoma of uterine cervix.
9. Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
Women who stop nursing before the study drug administration do not need to be
excluded from participating; they should refrain from breastfeeding up to 16 weeks after
the study drug administration (see Section 4.2.2).
10. Major surgery (major according to the investigator’s assessment) performed since the last
visit of previous BI 655130 trial or planned during the current trial, e.g. hip replacement,
aneurysm removal, stomach ligation), as assessed by the investigator.
11. Evidence of a current or previous disease, medical condition (including chronic alcohol
or drug abuse or any condition) other than GPP, surgical procedure, psychiatric or social
problems, medical examination finding (including vital signs and electrocardiogram
[ECG]), or laboratory value at the screening outside the reference range that in the
opinion of the investigator is clinically significant and would make the study participant
unreliable to adhere to the protocol, comply with all study visits/procedures or to
complete the trial, compromise the safety of the patient or compromise the quality of the
data. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
1) occurrence of treatment emergent adverse events (TEAEs) up to week 252 of maintenance treatment |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
1) The reoccurrence of a GPP flare defined by GPPGA (as defined in Section 3.1)
2) Time to first achievement of a GPPGA score of 0 or 1 (Patients received flare rescue Treatment) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) 252 weeks
2) 252 weeks |
|
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 | No |
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) | Yes |
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 | 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 | 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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 71 |
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 |
China |
France |
Germany |
Greece |
Japan |
Korea, Republic of |
Malaysia |
Mexico |
Poland |
Russian Federation |
Singapore |
Switzerland |
Taiwan |
Thailand |
Tunisia |
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 | 6 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 12 |
E.8.9.2 | In all countries concerned by the trial years | 6 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 12 |