A study to test whether spesolimab helps people with Generalized Pustular Psoriasis (GPP) who need treatment for repeated flares

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

11 Oct 2023 → ongoing

Decision date (initial)

2023-10-06

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

External identifiers

EU CT number

2022-502128-38-00

WHO UTN

U1111-1291-3088

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Therapy, Pharmacokinetic

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..

Conditions and MedDRA coding

Generalized Pustular Psoriasis

Study design 4 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 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 is provided in the participant information

Exclusion criteria 13

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. or i.v. (exception: exposure to i.v. spesolimab that occurred in trials 1368-0011 or 1368-0013 only are not excluded )
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. 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.
13. Further exclusion criteria apply.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Achievement of a GPPGA pustulation subscore of 0 indicating no visible pustules at Week 1

Secondary endpoints 1

1. Achievement of a GPPGA pustulation subscore of 0 or 1, with a ≥2-point reduction from baseline at Week 1. The baseline is the last measurement prior to the first dose of re-treatment with spesolimab i.v.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Boehringer Ingelheim International GmbH

Sponsor organisation

Boehringer Ingelheim International GmbH

Address

Binger Strasse 173

City

Ingelheim Am Rhein

Postcode

55216

Country

Germany

Scientific contact point

Organisation

Boehringer Ingelheim International GmbH

Contact name

CT Disclosure & Data Transparency

Public contact point

Organisation

Boehringer Ingelheim International GmbH

Contact name

CT Disclosure & Data Transparency

Boehringer Ingelheim Espana S.A.

Sponsor organisation

Boehringer Ingelheim Espana S.A.

Address

Carrer Prat De La Riba 50

City

Sant Cugat Del Valles

Postcode

08174

Country

Spain

Scientific contact point

Organisation

Boehringer Ingelheim Espana S.A.

Contact name

CT Disclosure & Data Transparency

Public contact point

Organisation

Boehringer Ingelheim Espana S.A.

Contact name

CT Disclosure & Data Transparency

Sponsor responsibilities

Article 77 compliance

Boehringer Ingelheim International GmbH

Contact point sponsor

Boehringer Ingelheim International GmbH

Article 77 implementation

Boehringer Ingelheim International GmbH

Locations

5 EU/EEA countries · 11 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 112 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

7 submissions — initial application plus substantial / non-substantial modifications