A 5-year study to test BI 655130 in patients with Generalized Pustular Psoriasis who took part in previous studies with BI 655130

• Register: EUCTR
• Last refreshed on: 14 October 2024
• Main ID: EUCTR2018-003080-56-FR
• Date of registration: 27/02/2019
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim France
• Public title: A 5-year study to test BI 655130 in patients with Generalized Pustular Psoriasis who took part in previous studies with BI 655130
• Scientific title: An open-label, long term extension study to assess the safety and efficacy of BI 655130 treatment in patients with Generalized Pustular Psoriasis (GPP)
• Date of first enrolment: 14/05/2019
• Target sample size: 101
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-003080-56
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Belgium, Bulgaria, China, France, Germany, Greece, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Poland, Russian Federation, Singapore, Spain, Switzerland, Taiwan, Thailand, Tunisia, United States

Contacts

• Name: QRPE PSC CT Information Disclosure
• Affiliation: Boehringer Ingelheim GmbH & Co KG

• Name: QRPE PSC CT Information Disclosure
• Affiliation: Boehringer Ingelheim GmbH & Co KG

Key inclusion & exclusion criteria

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 17

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Generalized Pustular Psoriasis
MedDRA version: 20.0 Level: LLT Classification code 10037159 Term: Psoriasis pustular System Organ Class: 100000004858

Intervention(s)

Product Code: BI 655130
Pharmaceutical Form: Solution for infusion
Current Sponsor code: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 60-

Product Code: BI 655130
Pharmaceutical Form: Solution for injection
Current Sponsor code: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-

Primary Outcome(s)

Main Objective: 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

Primary end point(s): 1) occurrence of treatment emergent adverse events (TEAEs) up to week 252 of maintenance treatment

Secondary Objective: The primary endpoint is the 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(s)

Timepoint(s) of evaluation of this end point: 1) 252 weeks
2) 252 weeks

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)

Secondary ID(s)

1368-0025

Source(s) of Monetary Support

Boehringer Ingelheim France

Ethics review

Status: Approved
Approval date: 14/05/2019
Contact: