Clinical trial • Phase IV • Dermatology

SPESOLIMAB for Generalized Pustular Psoriasis

Phase IV trial of SPESOLIMAB for Generalized Pustular Psoriasis. open-label. 108 participants.

Overview

Trial Therapeutic Area
Dermatology
Trial Disease
Generalized Pustular Psoriasis
Trial Stage
Phase IV
Drug Modality
Monoclonal antibody
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
21-12-2023
First CTIS Authorization Date
12-02-2024

Trial design

open-label Phase IV trial across 13 sites in Spain, Belgium, Italy and others.

Open Label
Yes
Target Sample Size
108
Trial Duration For Participant
1764

Eligibility

Recruits 108 paediatric patients.

Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). Inclusion criteria require "Signed and dated written informed consent and assent for the current trial 1368-0025, in accordance with ICH-GCP and local legislation prior to admission to the current trial", indicating assent for minors and consent per ICH-GCP/local legislation; parent(s) or patient's legal guardian referenced in patient information.

Inclusion criteria

  • {"criterion_text":"- Male or female patients who have completed the treatment period without premature discontinuation in the previous spesolimab trial (1368-0013 or 1368-0027) and are willing and able to continue treatment in the current trial"}
  • {"criterion_text":"- 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 the patient, parent(s) (or patient’s legal guardian) 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."}
  • {"criterion_text":"- Signed and dated written informed consent and assent for the current trial 1368-0025, in accordance with ICH-GCP and local legislation prior to admission to the current trial"}

Exclusion criteria

  • {"criterion_text":"- Evidence of flare symptoms of moderate/severe intensity at screening"}
  • {"criterion_text":"- Treatment with any restricted medication, or any drugs considered by the investigator likely to interfere with the safe conduct of the study since the last visit of the previous spesolimab trial and during the screening period for the current trial, with the exception of methotrexate, cyclosporine, or retinoids started following rescue treatment for GPP flare in trial 1368-0027."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- Patients with congestive heart disease, as assessed by the investigator."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- History of allergy/hypersensitivity to a systemically administered trial medication agent or its excipients."}
  • {"criterion_text":"- Further criteria apply."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Occurrence of treatment emergent adverse events (TEAEs) up to week 252 of maintenance treatment","definition_or_measurement_approach":"Occurrence and recording of treatment-emergent adverse events (TEAEs) observed up to week 252 of maintenance treatment (measured as incidence of TEAEs through week 252)"}

Secondary endpoints

  • {"endpoint_text":"- The reoccurrence of a GPP flare defined by GPPGA","definition_or_measurement_approach":"Reoccurrence of GPP flare as defined by the Generalized Pustular Psoriasis Global Assessment (GPPGA) score"}
  • {"endpoint_text":"- Time to first achievement of a GPPGA score of 0 or 1 in patients who received flare rescue treatment","definition_or_measurement_approach":"Time-to-event measurement: time from baseline to first achievement of GPPGA score 0 or 1 among patients receiving flare rescue treatment"}
  • {"endpoint_text":"- A GPPGA pustulation sub-score of 0 indicating no visible pustules, by visit in patients who received flare rescue treatment","definition_or_measurement_approach":"Assessment of GPPGA pustulation sub-score at each visit; sub-score of 0 indicates no visible pustules in patients who received flare rescue treatment"}
  • {"endpoint_text":"- Change from baseline in Psoriasis Symptom Scale (PSS) score, by visit in patients who received flare rescue treatment","definition_or_measurement_approach":"Change from baseline in Psoriasis Symptom Scale (PSS) score assessed at scheduled visits for patients who received flare rescue treatment"}

Recruitment

Planned Sample Size
108
Recruitment Window Months
103
Consent Approach
Signed and dated written informed consent and assent required prior to admission ('Signed and dated written informed consent and assent for the current trial 1368-0025, in accordance with ICH-GCP and local legislation prior to admission to the current trial'). Consent materials and ICFs are available for participating countries (documents in local languages present: Spanish, French, German, Italian, English as evidenced by country-specific ICFs). Parents/legal guardians are referenced in patient information where applicable.

Geography

Total Number Of Sites
13
Total Number Of Participants
25

Spain

Earliest CTIS Part Ii Submission Date
29-01-2024
Latest Decision Or Authorization Date
01-09-2025
Processing Time Days
581
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
Sant Joan De Deu Barcelona Hospital
Department Name
Servicio de Dermatología
Contact Person Name
Asuncion Vicente

Belgium

Earliest CTIS Part Ii Submission Date
29-01-2024
Latest Decision Or Authorization Date
25-08-2025
Processing Time Days
575
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
Cliniques Universitaires Saint-Luc
Department Name
Service de Dermatologie
Contact Person Name
Pierre-Dominique Ghislain

Italy

Earliest CTIS Part Ii Submission Date
29-01-2024
Latest Decision Or Authorization Date
28-08-2025
Processing Time Days
578
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
Humanitas Research Hospital
Department Name
U.O. Dermatologia
Contact Person Name
Antonio Costanzo
Contact Person Email
antonio.costanzo@hunimed.eu

France

Earliest CTIS Part Ii Submission Date
29-01-2024
Latest Decision Or Authorization Date
25-08-2025
Processing Time Days
575
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Service de Dermatologie
Contact Person Name
Thierry Passeron
Contact Person Email
thierry.passeron@unice.fr
Site Name
Centre Hospitalier Universitaire Reims
Department Name
Service Dermatologie
Contact Person Name
Manuelle-Anne Viguier
Contact Person Email
mviguier@chu-reims.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Polyclinique Dermatologique
Contact Person Name
Hervé Bachelez
Contact Person Email
herve.bachelez@aphp.fr
Site Name
CHU De Bordeauxt
Department Name
Service Dermatologie et Dermatologie Pédiatrique
Contact Person Name
Marie Beylot-Barry

Germany

Earliest CTIS Part Ii Submission Date
29-01-2024
Latest Decision Or Authorization Date
14-10-2025
Processing Time Days
625
Number Of Sites
6
Number Of Participants
12

Sites

Site Name
Universitaet Muenster
Department Name
Klinik für Hautkrankheiten
Contact Person Name
Nina Magnolo
Contact Person Email
nina.magnolo@ukmuenster.de
Site Name
Klinikum Oldenburg AöR
Department Name
Universitätsklinik für Dermatologie und Allergologie
Contact Person Name
Nikolaos Patsinakidis
Site Name
Thermalsole und Schwefelbad Bentheim GmbH
Department Name
Thermalsole- und Schwefelbad Bentheim GmbH
Contact Person Name
Athanasios Tsianakas
Contact Person Email
a.tsianakas@fk-bentheim.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik für Dermatologie, Venerologie und Allergologie
Contact Person Name
Kamran Ghoreschi
Contact Person Email
kamran.ghoreschi@charite.de
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Klinik und Poliklinik für Dermatologie und Allergologie
Contact Person Name
Felix Lauffer
Site Name
Universitaetsklinikum Bonn AöR
Department Name
SZB-Studienzentrale und Phase I-Einheit
Contact Person Name
Dagmar Wilsmann-Theis

Sponsor

Primary sponsor

Full Name
Boehringer Ingelheim International GmbH
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Third parties

  • {"country":"Spain","full_name":"Boehringer Ingelheim Espana S.A.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Spesolimab (SOLUTION FOR INFUSION)
Active Substance
SPESOLIMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised
Maximum Dose
900 mg (max daily dose amount)
Investigational Product Name
Spesolimab (SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE)
Active Substance
SPESOLIMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Authorisation Status
Authorised
Maximum Dose
300 mg (max daily dose amount)

Related trials

Other published trials that may interest you.