A 5-year study to test BI 655130 in patients with GeneralizedPustular Psoriasis who took part in previous studies with BI655130
- Conditions
- Generalized Pustular PsoriasisMedDRA version: 21.0Level: LLTClassification code 10037159Term: Psoriasis pustularSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2018-003080-56-ES
- Lead Sponsor
- Boehringer Ingelheim España S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 150
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
Are the trial subjects under 18? yes
Number of subjects for this age range: 8
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 23
1. 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):
- Patients with active tuberculosis should be excluded
- Patients will be screened with Interferon Gamma Release Assay (IGRA) such as QuantiFERON®-TB-Gold Plus or T-spot®. Patients with positive IGRA (indicating active or latent tuberculosis) are excluded unless they have completed treatment for active or latent tuberculosis per investigator discretion, at the time of screening.
- Patients with indeterminate QuantiFERON®-TB-Gold Plus or invalid/borderline T-spot® may be retested with IGRA (once) or Tuberculin Skin test (TST).
- TST or any alternative test/procedure (as per local standards) to rule out TB can be performed if IGRA is not available or indeterminate. A TST reaction =10mm (=5mm if receiving =15mg/d prednisone or other immunosuppressant) is considered positive. Patients with a positive TST are excluded unless they have completed treatment as above.
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.
12. Patients with a confirmed active infection with SARS-CoV-2 (as confirmed by PCR test). A patient may be enrolled once recovered from SARS-CoV-2 infection according to the investigator’s assessment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the long-term safety and efficacy of BI 655130 in patients with GPP, who have<br>completed previous BI 655130 trials and are qualified for entry in this trial;Secondary Objective: The primary endpoint is the occurrence of treatment emergent adverse events (TEAEs) up to<br>week 252 of maintenance treatment;Primary end point(s): 1) occurrence of treatment emergent adverse events (TEAEs) up to week 252 of maintenance treatment;Timepoint(s) of evaluation of this end point: 1) 252 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1) The reoccurrence of a GPP flare defined by GPPGA (as defined in Section 3.1)<br>2) Time to first achievement of a GPPGA score of 0 or 1 (Patients received flare rescue Treatment)<br>3) A GPPGA pustulation sub-score of 0 indicating no visible pustules, by visit (Patients received flare rescue treatment)<br>4)Change from baseline in Psoriasis Symptom Scale (PSS) score, by visit (Patients received flare rescue treatment);Timepoint(s) of evaluation of this end point: 1) 252 weeks<br>2) 252 weeks<br>3) 252 weeks<br>4) 252 weeks