A study to test whether spesolimab helps people with Generalized Pustular Psoriasis who need treatment for repeated flares
- Conditions
- Health Condition 1: L401- Generalized pustular psoriasis
- Registration Number
- CTRI/2024/01/061469
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Patients will be enrolled (screened) into the trial, if they meet the following criteria (please refer to Section 3.3.3 for criteria for initiation of first treatment with spesolimab i.v. in this trial):
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.
2. 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.
3. Male or female patients, aged =18 years (if local legislation for age of consent differs, then local legislation will be followed) at screening.
4. 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.
5. 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.
1. Drug-triggered Acute Generalized Exanthematous Pustulosis (AGEP)
2. Patients with primary plaque psoriasis vulgaris without presence of pustules or with pustules that are restricted to psoriatic plaques.
3. Patients with primary erythrodermic psoriasis vulgaris.
4. Patients with SAPHO (Synovitis–acne–pustulosis–hyperostosis–osteitis) syndrome.
5. 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.
6. 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.
7. Presence of acute demyelinating neuropathy
8. Treatment with any drug considered likely to interfere with the safe conduct of the trial, as assessed by the investigator.
9. Prior use of spesolimab s.c.
10. Prior use of any other IL-36R inhibitor (e.g.imsidolimab) i.v. and/or s.c.
11. 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.
12. Relevant chronic or acute infections including active tuberculosis, HIV infection or viral hepatitis at the time of initial treatment. A patient can be re-screened if the patient was treated and is cured from the acute infection.
13. Active or Latent TB:
QuantiFERON® (or if applicable, T-Spot®) TB test will be performed at screening. If the result is positive, the patient may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the patient has no evidence of active tuberculosis. Active TB patients must be excluded. If presence of latent tuberculosis is established, then treatment should have been initiated and maintained according to local country guidelines. For patients screened while having a flare (inclusion criteria 1b), if the TB test results are not available in time for initiation of first treatment in this trial, these patients may receive the treatment (provided they meet all other inclusion/exclusion criteria) as long as the investigator has ruled out active disease based on available documented history (i.e. negative for active TB) within 3 months prior to Visit 2.
14. Severe or life-threatening hypersensitivity to the active substance or any of its
excipients.
15. Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.
16. Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational treatment(s).
17. Women who are pregnant, nursing, or who plan to become pregnant while in the trial. Women who stop nursing before the study drug administration do not need to be excluded from participating; they should refrain from breastfeeding for 16 weeks after the last study drug administration.
18. Major surgery (major according to t
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the response to recurrent flare(s) treatment with Spesolimab i.v. after first flare treatment with spesolimab i.v.Timepoint: Week 1
- Secondary Outcome Measures
Name Time Method To evaluate the potential impact of immunogenicity on this response of recurrent flare treatment with spesolimabTimepoint: Week 1