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Effisayil™ ON: A Study to Test Long-term Treatment With Spesolimab in People With Generalized Pustular Psoriasis Who Took Part in a Previous Study

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ClinicalTrials.gov Identifier: NCT03886246
Recruitment Status : Recruiting
First Posted : March 22, 2019
Last Update Posted : September 21, 2022
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
To evaluate the long-term safety and efficacy of spesolimab in patients with GPP, who have completed previous spesolimab trials and are qualified for entry in this trial.

Condition or disease Intervention/treatment Phase
Generalized Pustular Psoriasis Drug: Spesolimab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 155 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effisayil™ ON: An Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Spesolimab Treatment in Patients With Generalized Pustular Psoriasis (GPP)
Actual Study Start Date : May 27, 2019
Estimated Primary Completion Date : September 30, 2027
Estimated Study Completion Date : January 20, 2028

Arm Intervention/treatment
Experimental: Spesolimab (every 6 weeks) Drug: Spesolimab
Solution for infusion

Drug: Spesolimab
Solution for injection

Experimental: Spesolimab (every 12 weeks) Drug: Spesolimab
Solution for injection

Experimental: Spesolimab (every 4 weeks) Drug: Spesolimab
Solution for injection

Primary Outcome Measures :
  1. Occurrence of treatment emergent adverse events (TEAEs) up to week 252 of maintenance treatment [ Time Frame: Up to 252 Weeks ]

Secondary Outcome Measures :
  1. The reoccurrence of a GPP flare defined by GPPGA [ Time Frame: Up to 252 Weeks ]
    The total GPPGA score ranges from 0 to 4 with a higher score indicating a higher grade of inflammation.

  2. Time to first achievement of a GPPGA score of 0 or 1 (Patients received flare rescue Treatment) [ Time Frame: Up to 252 Weeks ]
  3. A GPPGA pustulation sub-score of 0 indicating no visible pustules, by visit [ Time Frame: Up to 252 Weeks ]
  4. Change from baseline in Psoriasis Symptom Scale (PSS) score, by visit [ Time Frame: Up to 252 Weeks ]
    The PSS score ranges from None to Very Severe with a higher score indicating a higher severity of psoriasis symptom.

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female patients who have completed the treatment period without premature discontinuation in the previous spesolimab trial and are willing and able to continue treatment in the current trial
  • 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 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.
  • 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:

  • Evidence of flare symptoms of moderate/severe intensity at screening.
  • Treatment with any restricted medication as specified in the protocol, 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.
  • Severe, progressive, or uncontrolled hepatic disease, defined as >3- fold Upper Limit of Normal (ULN) elevation in Aspartate Transaminase (AST) or Alanine Aminotransferase (ALT) or alkaline phosphatase, or >2- fold ULN elevation in total bilirubin.
  • Patients with congestive heart disease, as assessed by the investigator.
  • 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.
  • 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.
  • History of allergy/hypersensitivity to a systemically administered trial medication agent or its excipients.
  • 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.

Further exclusion criteria apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03886246

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

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Sponsors and Collaborators
Boehringer Ingelheim
Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03886246    
Other Study ID Numbers: 1368-0025
2018-003080-56 ( EudraCT Number )
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: September 21, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
URL: https://www.mystudywindow.com/msw/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Skin Diseases, Papulosquamous
Skin Diseases