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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04399837
Registration number
NCT04399837
Ethics application status
Date submitted
20/05/2020
Date registered
22/05/2020
Date last updated
20/04/2023
Titles & IDs
Public title
A Study to Test Whether BI 655130 (Spesolimab) Prevents Flare-ups in Patients With Generalized Pustular Psoriasis
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Scientific title
Effisayilâ„¢ 2: Multi-center, Randomized, Parallel Group, Double Blind, Placebo Controlled, Phase IIb Dose-finding Study to Evaluate Efficacy and Safety of BI 655130 (Spesolimab) Compared to Placebo in Preventing Generalized Pustular Psoriasis (GPP) Flares in Patients With History of GPP
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Secondary ID [1]
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2018-003081-14
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Secondary ID [2]
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1368-0027
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Generalized Pustular Psoriasis
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Condition category
Condition code
Skin
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Dermatological conditions
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Skin
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Spesolimab
Treatment: Drugs - Placebo
Experimental: Spesolimab SC low dose -
Experimental: Spesolimab SC medium dose -
Experimental: Spesolimab SC high dose -
Placebo Comparator: Placebo -
Treatment: Drugs: Spesolimab
Solution for injection
Treatment: Drugs: Placebo
Solution for injection
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to first Generalized Pustular Psoriasis (GPP) flare
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Assessment method [1]
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Timepoint [1]
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up to 48 weeks
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Secondary outcome [1]
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Occurrence of at least one GPP flare
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Assessment method [1]
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Timepoint [1]
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up to 48 weeks
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Secondary outcome [2]
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Time to first worsening of Psoriasis Symptom Scale (PSS)
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Assessment method [2]
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Timepoint [2]
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up to 48 weeks
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Secondary outcome [3]
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Time to first worsening of Dermatology Quality of Life Index (DLQI)
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Assessment method [3]
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Timepoint [3]
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up to 48 weeks
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Secondary outcome [4]
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Sustained remission
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Assessment method [4]
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Defined as a patient with a GPPGA score of 0 or 1 (clear or almost clear) at all visits up to week 48, without intake of rescue medication, or investigator-prescribed Standard of Care (SoC).
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Timepoint [4]
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up to 48 weeks
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Secondary outcome [5]
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Occurrence of treatment emergent adverse events (TEAEs)
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Assessment method [5]
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Timepoint [5]
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up to 64 weeks
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Eligibility
Key inclusion criteria
- Patients with a known and documented history of GPP per ERASPEN criteria (see Section
3.3.1) regardless of IL36RN mutation status, with at least 2 presentations of moderate
to severe GPP flares with fresh pustulation (new appearance or worsening) in the past.
- Patients with a GPPGA score of 0 or 1 at screening and randomization.
- Patients who are not on concomitant GPP treatment at time of randomization (V2) must
have had at least two presentations of moderate to severe GPP flare in the past year,
at least one of which had evidence of either fever and/or elevated CRP and/or elevated
WBC, and/or asthenia and/or myalgia.
- Patients who are not on concomitant GPP treatment at time of randomization (V2) but
who were on concomitant GPP treatment until shortly before randomization (V2) (= 12
weeks before randomization), these patients must have a history of flaring while on
concomitant treatment for GPP or in case of dose reduction or discontinuation of their
concomitant medication.
- Patients who are on concomitant treatment regimen with retinoids and/or methotrexate
and/or cyclosporine must stop at the day of randomization (V2). These patients must
have a history of flaring while on concomitant treatment for GPP or in case of dose
reduction or discontinuation of these concomitant medications.
- Male or female patients, aged 12 to 75 years at screening. For all patients, a minimum
weight of 40 kg is required.
- Signed and dated written informed consent and assent in accordance with ICH-GCP and
local legislation prior to admission in the trial.
- Women of childbearing potential (WOCBP)1 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 the CTP as well as in the patient,
parent(s) (or patient's legal guardian) information.
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Minimum age
12
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Maximum age
75
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Patients with SAPHO (Synovitis-acne-pustulosis-hyperostosis-osteitis) syndrome.
2. Patients with primary erythrodermic psoriasis vulgaris.
3. Severe, progressive, or uncontrolled hepatic disease, defined as >3-fold Upper Limit
of Normal (ULN) elevation in Aspartate Aminotransferase (AST) or Alanine
Aminotransferase (ALT) or alkaline phosphatase, or >2-fold ULN elevation in total
bilirubin.
4. Treatment with:
1. Any restricted medication as specified in the CTP, or any drug considered likely
to interfere with the safe conduct of the study, as assessed by the investigator.
2. Any prior exposure to BI 655130 or another IL36R inhibitor biologic.
5. Increased risk of infectious complications (e.g. recent pyogenic infection, any
congenital or acquired immunodeficiency (e.g. HIV), past organ or stem cell
transplantation), as assessed by the investigator.
6. Relevant chronic or acute infections including active tuberculosis, human
immunodeficiency virus (HIV) infection or viral hepatitis at the time of
randomization. A patient can be re-screened if the patient was treated and is cured
from the acute infection.
7. Active or Latent Tuberculosis (TB):
- Patients with active tuberculosis should be excluded
- Patients with a positive QuantiFERON® (or if applicable, T-Spot®) TB test during
screening are excluded, unless the patient had previous diagnosis of active or
latent TB and has completed appropriate treatment per the discretion of the local
investigator within the last 3 years and at the latest at the time of screening
(i.e. 2 to 4 weeks before study drug administration); patients may be re-screened
once to meet this criterion)
- Patients with suspected false positive or indeterminate QuantiFERON® (or if
applicable, T-Spot®) TB result may be re-tested once
- If QuantiFERON® (or if applicable, T-Spot®) TB testing is not available or
provides indeterminate results after repeat testing, a tuberculin skin test (TST)
can be performed: A TST reaction of =10mm (=5mm if receiving =15mg/d prednisone
or its equivalent) is considered positive.
8. History of allergy/hypersensitivity to the systemically administered trial medication
agent or its excipients.
Further exclusion criteria apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
4/06/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
23/11/2022
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Sample size
Target
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Accrual to date
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Final
123
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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United States of America
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Michigan
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Bruxelles
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Chile
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Vitacura
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Guangzhou
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Hangzhou
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Xi'An
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Nice
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Ha Noi
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Ho Chi Minh
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Boehringer Ingelheim
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Ethics approval
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Summary
Brief summary
This is a study in adolescents and adults with Generalized Pustular Psoriasis (GPP). People
between 12 and 75 years old can take part in the study. The study is open to people who had
GPP flare-ups in the past but whose skin is clear or almost clear when they join the study.
The purpose of the study is to test 3 different doses of a medicine called spesolimab and to
see whether it helps to prevent GPP flare-ups.
Participants are put into 4 groups by chance. Three groups get different doses of spesolimab.
The fourth group gets a placebo. Placebo looks like spesolimab but does not contain any
medicine.
Spesolimab and placebo are given as an injection under the skin. Participants are in the
study for about 1 year and 4 months. During this time, they visit the study site about 15
times. For the first 11 months, participants get spesolimab or placebo injections every
month. At the study visits, the doctors check participants' skin for signs of a new GPP
flare-up. The doctors also check the general health of the participants.
If a participant has a GPP flare-up during the study, more visits may be necessary. In case
of a flare-up, participants get a dose of spesolimab as an infusion into a vein.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04399837
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04399837
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