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NCT03782792 | SNCTP000003348

Eine Studie zur Untersuchung von BI 655130 bei Patienten mit einem Schub einer Hautkrankheit, der sogenannten generalisierten pustulösen Psoriasis

Data source: BASEC (Imported from 19.07.2019), WHO (Imported from 07.07.2019)
Changed: 12.07.2019
Disease category: Haut- und Bindegewebekrankheiten (nicht Krebs)

Brief description of trial (Source of data: BASEC)

Die Studie untersucht eine seltene und schwere entzündliche Hautkrankheit, die generalisierte pustulöse Psoriasis (GPP). Diese Hautkrankheit verursacht Entzündungen der Haut und kann auch die inneren Organe befallen. Die Studie wird durchgeführt, um die Wirksamkeit, Verträglichkeit und Sicherheit einer intravenösen (i. v.) Einzeldosis des Prüfpräparats BI 655130 mit einer wirkstofffreien Substanz (Placebo) bei Patienten mit GPP zu vergleichen; zu untersuchen, wie der Körper BI 655130 verarbeitet

Health conditions investigated (Source of data: BASEC)

Generalisierte pustulöse Psoriasis (GPP)

Health conditions (Source of data: WHO)

Generalized Pustular Psoriasis

Rare disease (Source of data: BASEC)

Yes

Intervention investigated (e.g. drug, therapy or campaign) (Source of data: BASEC)

Therapie mit BI 655130 oder Placebo bei Patienten mit generalisierter pustulöser Psoriasis (GPP)

Interventions (Source of data: WHO)

Drug: BI 655130

Criteria for participation in trial (Source of data: BASEC)

•Männliche oder weibliche Patienten im Alter von 18 bis 75 Jahren
•Patienten mit einem GPPGA-Wert von 0 oder 1 (GPPGA = Generalized Pustular Psoriasis Physician Global Assessment/Gesamtbeurteilung der generalisierten pustulösen Psoriasis durch den Prüfarzt) und bekannter und dokumentierter Vorgeschichte einer generalisierten pustulösen Psoriasis.
ODER
•Patienten mit einem akuten Schub von mittlerer bis schwerer Intensität einer generalisierten pustulösen Psoriasis mit bekannter und dokumentierter Vorgeschichte einer generalisierten pustulösen Psoriasis
ODER
•Patienten mit einer ersten Episode eines akuten Schubs der generalisierten pustulösen Psoriasis von mittlerer bis schwerer Intensität

Exclusion criteria (Source of data: BASEC)

•Patienten mit SAPHO-Syndrom.
•Patienten mit primärer erythrodermischer Psoriasis vulgaris.
•Patienten mit primärer Plaque-Psoriasis (Psoriasis vulgaris) ohne Pusteln oder mit Pusteln, die sich auf die psoriatischen Plaques beschränken.
•Unmittelbar lebensbedrohlicher Schub der GPP oder Schub, der intensivmedizinisch behandelt werden muss, nach Urteil des Prüfarztes.
•Schwere, fortschreitende oder unkontrollierte Lebererkrankung,
•Patienten, bei denen innerhalb von 2 Wochen vor Verabreichung der ersten Dosis BI 655130/Placebo eine Dosiserhöhung ihrer Erhaltungstherapie mit Ciclosporin und/oder Methotrexat und/oder Retinoiden vorgenommen wurde.
•Einleitung einer Behandlung mit systemisch wirkenden Arzneimitteln wie Ciclosporin und/oder Retinoiden und/oder Methotrexat 2 Wochen vor Verabreichung der ersten Dosis BI 655130/Placebo.

Inclusion/Exclusion Criteria (Source of data: WHO)


Inclusion Criteria:

- Patients with GPPGA of 0 or 1 and a known and documented history of GPP per European
Rare And Severe Psoriasis Expert Network (ERASPEN) criteria regardless of IL36RN
mutation status, 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

-- 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, 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)

- Male or female patients, aged 18 to 75 years at screening.

- Signed and dated written informed consent prior to admission to the study in
accordance with ICH GCP and local legislation prior to start of any screening
procedures.

- 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, 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

- Further inclusion criteria apply

Exclusion Criteria:

- Patients with SAPHO (Synovitis-acne-pustulosis-hyperostosis-osteitis) syndrome.

- Patients with primary erythrodermic psoriasis vulgaris.

- Patients with primary plaque psoriasis vulgaris without presence of pustules or with
pustules that are restricted to psoriatic plaques.

- Drug-triggered Acute Generalized Exanthematous Pustulosis (AGEP).

- Immediate life-threatening flare of GPP or requiring intensive care treatment,
according to the investigator's judgement. Lifethreatening complications mainly
include, but are not limited to, cardiovascular/cytokine driven shock, pulmonary
distress syndrome, or renal failure.

- 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 exclusion criteria apply

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT03782792

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT03782792

Further information on trial

Date trial registered

19.12.2018

Incorporation of the first participant

31.01.2019

Recruitment status

Recruiting

Academic title (Source of data: WHO)

Multi-center, Double-blind, Randomised, Placebo-controlled, Phase II Study to Evaluate Efficacy, Safety and Tolerability of a Single Intravenous Dose of BI 655130 in Patients With Generalized Pustular Psoriasis (GPP) Presenting With an Acute Flare of Moderate to Severe Intensity.

Type of trial (Source of data: WHO)

Interventional

Design of the trial (Source of data: WHO)

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).

Phase (Source of data: WHO)

Phase 2

Primary end point (Source of data: WHO)

A Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) score of 0 or 1 at Week 1

Secundary end point (Source of data: WHO)

Change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score at Week 4;Change from baseline in Psoriasis Symptom Scale (PSS) score at Week 4;Change from baseline in Pain Visual Analog Scale (VAS) score at Week 4

Contact information (Source of data: WHO)

Please refer to primary and secondary sponsors

Trial sites

Trial sites in Switzerland (Source of data: BASEC)

Basel, Lausanne

Countries (Source of data: WHO)

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

Contact for further information on the trial

Details of contact in Switzerland (Source of data: BASEC)

Prof. Dr. Curdin Conrad
+41 21 314 1111
curdin.conrad@chuv.ch

Contact for general information (Source of data: WHO)

Boehringer Ingelheim
1-800-243-0127
clintriage.rdg@boehringer-ingelheim.com

Contact for scientific information (Source of data: WHO)

Boehringer Ingelheim
1-800-243-0127
clintriage.rdg@boehringer-ingelheim.com

Principal Sponsor/Investigator

Principal sponsor (Source of data: WHO)

Boehringer Ingelheim

Further trial identification numbers

BASEC ID (Source of data: BASEC)

2018-02203

Secondary ID (Source of data: WHO)

2017-004231-37