A study to test BI 655130 in patients with a flare-up of a skin disease called Generalized Pustular Psoriasis

• Register: EUCTR
• Last refreshed on: 5 April 2021
• Main ID: EUCTR2017-004231-37-FR
• Date of registration: 26/11/2018
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim France
• Public title: A study to test BI 655130 in patients with a flare-up of a skin disease called Generalized Pustular Psoriasis
• Scientific title: Multi-center, double-blind, randomised, placebo-controlled, Phase II study to evaluate efficacy, safety and tolerability of BI 655130 in patients with Generalized Pustular Psoriasis (GPP) presenting with an acute flare of moderate to severe intensity. - Flare Treatment Phase II Trial in GPP
• Date of first enrolment: 22/01/2019
• Target sample size: 27
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-004231-37
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

France, Germany, Japan, Malaysia, Singapore, Switzerland, Taiwan, Thailand, Tunisia, United States

Contacts

• Name: QRPE PSC CT Information Disclosure
• Affiliation: Boehringer Ingelheim

• Name: QRPE PSC CT Information Disclosure
• Affiliation: Boehringer Ingelheim

Key inclusion & exclusion criteria

Inclusion criteria:
1. a. Patients with GPPGA score of 0 or 1 and a known and documented history of GPP (per ERASPEN criteria) regardless of IL36RN mutation status, and in addition with previous evidence of fever, and/or asthenia, and/or myalgia, and/or elevated C-reactive protein, and/or leukocytosis with peripheral blood neutrophilia (above ULN)
OR
b. Patients with an acute flare of moderate to severe intensity meeting the ERASPEN criteria of GPP with a known and documented history of GPP (per ERASPEN criteria) regardless of IL36RN mutation status, and in addition with previous evidence of fever, and/or asthenia, and/or myalgia, and/or elevated C-reactive protein, and/or leucocytosis with peripheral blood neutrophilia (above ULN).
OR
c. Patients with first episode of an acute GPP flare of moderate to severe intensity with evidence of fever, and/or asthenia, and/or myalgia, and/or elevated C-reactive protein, and/or leucocytosis with peripheral blood neutrophilia (above ULN). For these patients the diagnosis will be confirmed retrospectively by a central external expert/committee.
2. Patients may or may not be receiving background treatment with retinoids and/or methotrexate and/or cyclosporine. Patients must discontinue retinoids/methotrexate/cyclosporine prior to receiving the first dose of BI 655130 or placebo.
3. Male or female patients, aged 18 to 75 years at screening.
4. Signed and dated written informed consent prior to admission to the study in accordance with ICHGCP and local legislation prior to start of any screening procedures.
5. 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. Note: A woman is considered of childbearing potential (WOCBP), 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.
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 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion criteria:
1. Patients with SAPHO (Synovitis–acne–pustulosis–hyperostosis–osteitis) syndrome.
2. Patients with primary erythrodermic psoriasis vulgaris.
3. Patients with primary plaque psoriasis vulgaris without presence of pustules or with pustules that are restricted to psoriatic plaques.
4. Drug-triggered Acute Generalized Exanthematous Pustulosis (AGEP).
5. Immediate life-threatening flare of GPP or requiring intensive care treatment, according to the Investigator’s judgement. Life-threatening complications mainly include, but are not limited to, cardiovascular/cytokine driven shock, pulmonary distress syndrome, or renal failure.
6. 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.

Further criteria apply.


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 (GPP)
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
INN or Proposed INN: BI 655130
CAS Number: *MASKED*
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-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Main Objective: To evaluate efficacy, safety, and tolerability of BI 655130 compared to placebo in patients with Generalized Pustular Psoriasis (GPP) presenting with an acute flare of moderate to severe intensity

Primary end point(s): 1- A Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) score of 0 or 1 at Week 1
2- A GPPGA pustulation sub-score of 0 indicating no visible pustules at Week 1

Timepoint(s) of evaluation of this end point: 1- Up to week 1
2- Up to week 1

Secondary Objective: Not applicable

Secondary Outcome(s)

Secondary end point(s): 1- A Psoriasis Area and Severity Index for Generalized Pustular Psoriasis (GPPASI) 75 at Week 4
2- Change from baseline in Pain Visual Analog Scale (VAS) score at Week 4.
3- Change from baseline in Psoriasis Symptom Scale (PSS) score at Week 4
4- Change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score at Week 4

Timepoint(s) of evaluation of this end point: 1- Up to week 4
2- Up to week 4
3- Up to week 4
4- Up to week 4

Secondary ID(s)

1368-0013

Source(s) of Monetary Support

Boehringer Ingelheim

Ethics review

Status: Approved
Approval date: 15/01/2019
Contact: