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A study to test whether spesolimab helps people with Generalized Pustular Psoriasis (GPP) who need treatment for repeated flares
EU CTIS ID: 2022-502128-38-00
What this study is testing
The main objective is to evaluate the response to recurrent flare(s) treatment with spesolimab i.v. after first flare treatment with spesolimab i.v..
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- a. Patients with a GPPGA pustulation subscore of 0 or 1 and a known and documented history of GPP (per ERASPEN criteria), regardless of IL-36RN mutation status b. Patients with a GPP flare and a known and documented history of GPP (per ERASPEN criteria) regardless of IL-36RN mutation status
- Patients must have a history of frequent GPP flares in the past: a. Patients who are not on concomitant GPP treatment at the time of screening must have had at least 2 presentations of GPP flares in the past year b. Patients who are on concomitant GPP treatment must stop this treatment at the day of initial administration of trial drug (Visit 2). These patients must have a history of flaring in case of dose reduction or discontinuation of their concomitant GPP medication.
- Male or female patients, aged ≥18 years (if local legislation for age of consent differs, then local legislation will be followed) at screening.
- Signed and dated written informed consent prior to admission to the trial in accordance with ICH GCP and local legislation prior to start of any screening procedures.
- Women of childbearing potential (WOCBP) 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 and instructions on the duration of their use is provided in the participant information
You likely can't join if
- Drug-triggered Acute Generalized Exanthematous Pustulosis (AGEP).
- Prior use of any other IL-36R inhibitor (e.g.imsidolimab) i.v. and/or s.c.
- 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.
- Relevant chronic or acute infections including active tuberculosis, HIV infection or viral hepatitis at the time of initial treatment. For patients screened while having a flare, if Visit 1 HIV or viral hepatitis results are not available in time for dosing, these patients may receive treatment as long as the investigator has ruled out active disease based on available documented history (i.e. negative HIV and viral hepatitis test results) within 3 months prior to Visit 2. A patient can be re-screened if the patient was treated and is cured from the acute infection.
- Further exclusion criteria apply.
- Patients with primary plaque psoriasis vulgaris without presence of pustules or with pustules that are restricted to psoriatic plaques.
See the full eligibility criteria
Who can join
- a. Patients with a GPPGA pustulation subscore of 0 or 1 and a known and documented history of GPP (per ERASPEN criteria), regardless of IL-36RN mutation status b. Patients with a GPP flare and a known and documented history of GPP (per ERASPEN criteria) regardless of IL-36RN mutation status
- Patients must have a history of frequent GPP flares in the past: a. Patients who are not on concomitant GPP treatment at the time of screening must have had at least 2 presentations of GPP flares in the past year b. Patients who are on concomitant GPP treatment must stop this treatment at the day of initial administration of trial drug (Visit 2). These patients must have a history of flaring in case of dose reduction or discontinuation of their concomitant GPP medication.
- Male or female patients, aged ≥18 years (if local legislation for age of consent differs, then local legislation will be followed) at screening.
- Signed and dated written informed consent prior to admission to the trial in accordance with ICH GCP and local legislation prior to start of any screening procedures.
- Women of childbearing potential (WOCBP) 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 and instructions on the duration of their use is provided in the participant information
What rules you out
- Drug-triggered Acute Generalized Exanthematous Pustulosis (AGEP).
- Prior use of any other IL-36R inhibitor (e.g.imsidolimab) i.v. and/or s.c.
- 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.
- Relevant chronic or acute infections including active tuberculosis, HIV infection or viral hepatitis at the time of initial treatment. For patients screened while having a flare, if Visit 1 HIV or viral hepatitis results are not available in time for dosing, these patients may receive treatment as long as the investigator has ruled out active disease based on available documented history (i.e. negative HIV and viral hepatitis test results) within 3 months prior to Visit 2. A patient can be re-screened if the patient was treated and is cured from the acute infection.
- Further exclusion criteria apply.
- Patients with primary plaque psoriasis vulgaris without presence of pustules or with pustules that are restricted to psoriatic plaques.
- Patients with primary erythrodermic psoriasis vulgaris.
- Patients with SAPHO (Synovitis–acne–pustulosis–hyperostosis–osteitis) syndrome.
- 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 acute renal failure.
- Severe, progressive, or uncontrolled hepatic disease, defined as >3-fold ULN elevation in AST or ALT or alkaline phosphatase, or >2-fold ULN elevation in total bilirubin.
- Presence of acute demyelinating neuropathy
- Treatment with any drug considered likely to interfere with the safe conduct of the trial, as assessed by the investigator.
- Prior use of spesolimab s.c. or i.v. (exception: exposure to i.v. spesolimab that occurred in trials 1368-0011 or 1368-0013 only are not excluded )
The study team makes the final eligibility decision.
Where it's taking place
- Thailand
- South Africa
- Taiwan
- Malaysia
- United States
- Vietnam
- Singapore
- Tunisia
- Korea, Republic of
- Australia
- Brazil
- China
- India
- Switzerland
- Turkey
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Thailand; South Africa; Taiwan; Malaysia; United States; Vietnam and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.