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Generalized Pustular PsoriasisPhase 3NCT05200247

An Expanded Access Trial in Japan to Provide Spesolimab to People With a Flare-up in Generalized Pustular Psoriasis Who Have no Other Treatment Options

A Phase 3 study testing spesolimab in people with Generalized Pustular Psoriasis, run by Boehringer Ingelheim at 9 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This Expanded Access trial in Japan is open to people with a serious skin disease called Generalized Pustular Psoriasis (GPP). This program provides a medicine called spesolimab to people with a GPP flare-up who have no alternative treatment options. Participants get a single infusion of spesolimab into a vein. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Generalized Pustular Psoriasis
What is being tested?
spesolimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
9 sitesJapan
Study dates
17 Feb 2022to 20 Mar 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of GPP confirmed based on the Japanese Dermatological Association (JDA) guidelines for the management and treatment of GPP.
  • Patient is experiencing a flare, defined as new or worsening of widespread eruption of sterile macroscopically visible pustules, with or without systemic inflammation, as assessed by the investigator.
  • Male or female patients, aged 18 to 75 years at time of enrollment. Women of childbearing potential (WOCBP) must be willing and able to use a highly effective method of birth control per International Council for Harmonization (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 information.
  • Signed and dated written informed consent in accordance with International Council for Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
  • No satisfactory authorised alternative therapy exists, as assessed by the investigator.

Who cannot join

  • Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
  • -- Women who stop nursing before study drug administration do not need to be excluded from participating; they should refrain from breastfeeding for 16 weeks after the last spesolimab infusion.
  • Severe, progressive, or uncontrolled hepatic disease, defined as >3-fold Upper Level of Normal (ULN) elevation in Aspartate Transaminase (AST) or Alanine Aminotransferase (ALT) or alkaline phosphatase, or >2-fold ULN elevation in total bilirubin.
  • Active systemic infections (fungal and bacterial disease) during the last 2 weeks prior to drug administration, as assessed by the investigator.
  • Increased risk of infectious complications (e.g. recent pyogenic infection, any congenital or acquired immunodeficiency (e.g. Human Immunodeficiency Virus (HIV)), past organ or stem cell transplantation), as assessed by the investigator.
  • Relevant chronic or acute infections, including active tuberculosis (TB), HIV infection or viral hepatitis at the time of drug administration.
Show all 12Show fewer
  • Patients should be evaluated for TB infection prior to initiating treatment with spesolimab.
  • Anti-TB therapy should be considered, in accordance with local guidelines, prior to initiating spesolimab in patients with latent TB or a history of TB.
  • History of allergy / hypersensitivity to systemically administered spesolimab or its excipients.
  • 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.
  • Immediate life-threatening flare of GPP requiring intensive care treatment according to the investigator's judgement. Life-threatening complications include cardiovascular / cytokine driven shock, pulmonary distress syndrome, or renal failure.
  • Further exclusion criteria apply.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Japan9 sites

  • Nagoya City University Hospital

    Aichi, Nagoya, 467-8602

  • Fukuoka University Hospital

    Fukuoka, Fukuoka, 814-0180

  • Kagoshima University Hospital

    Kagoshima, Kagoshima, 890-8520

  • Mie University Hospital

    Mie, Tsu, 514-8507

  • Tohoku University Hospital

    Miyagi, Sendai, 980-8574

  • Saitama Medical University Hospital

    Saitama, Iruma-gun, 350-0495

  • Jichi Medical University Hospital

    Tochigi, Shimotsuke, 329-0498

  • Teikyo University Hospital

    Tokyo, Itabashi-ku, 173-8606

  • Tokyo Medical University Hospital

    Tokyo, Shinjuku-ku, 160-0023

Other trials in Japan

About this study

Official title: Multi-centre, Open-label, Expanded Access Trial of Spesolimab i.v. in Patients With Generalized Pustular Psoriasis (GPP) Presenting With a Flare

This Expanded Access trial in Japan is open to people with a serious skin disease called Generalized Pustular Psoriasis (GPP). This program provides a medicine called spesolimab to people with a GPP flare-up who have no alternative treatment options.

Participants get a single infusion of spesolimab into a vein. They can get another spesolimab infusion one week after the first infusion if the doctors think it is helpful.

Participants are in the program for about 4 months and visit the study site about 5 to 6 times. The doctors regularly check participants' health and take note of any unwanted effects.

Being tested
spesolimab
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • spesolimabDrug

    solution for infusion

Study groups in NCT05200247
Study groupRoleWhat they receive
SpesolimabExperimentalNot described
Receives: Drug: spesolimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of Treatment Emergent Adverse Events (TEAEs)

    Number of patients with any treatment emergent adverse events (TEAEs) is reported.

    An adverse events (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment.

    An AE that started before first drug intake and deteriorated under treatment were also considered as 'treatment-emergent'.

    Measured: From first administration of study drug until last administration of study drug + 16 weeks of follow up, up to 6.3 months.

Secondary outcomes (2)

  1. Occurrence of Treatment Emergent Serious Adverse Events (SAEs)

    Number of patients with treatment emergent serious adverse events (SAEs) is reported.

    A serious adverse event (SAE) was defined as any AE which fulfils at least one of the following criteria:

    • results in death,
    • is life-threatening, which refers to an event in which the patient was at risk of death at the time of the event;
    • requires inpatient hospitalisation or prolongation of existing hospitalisation,
    • results in persistent or significant disability or incapacity,
    • is a congenital anomaly / birth defect,
    • is deemed serious for any other reason if it is an important medical event when based on appropriate medical judgement which may jeopardise the patient and may require medical or surgical intervention to prevent one of the other outcomes listed in the above definitions.
    • An event that possibly leads to disability will be handled as 'deemed serious for any other reason' and, therefore, reported as an SAE.

    Measured: From first administration of study drug until last administration of study drug + 16 weeks of follow up, up to 6.3 months.

  2. Occurrence of Treatment Emergent Adverse Events of Special Interest (AESIs)

    Number of patients with treatment emergent adverse events of special interest (AESIs) is reported.

    The term adverse events of special interest (AESI) relates to any specific adverse event (AE) that has been identified at the project level as being of particular concern for prospective safety monitoring and safety assessment within this trial, e.g. the potential for AEs based on knowledge from other compounds in the same class.

    The following are considered as AESIs:

    • Potential Severe Drug Induced Liver Injury (DILI)
    • Systemic hypersensitivity reactions including infusion reactions and anaphylactic reaction
    • Severe infections (according to RCTC grading in the ISF)
    • Opportunistic and mycobacterium tuberculosis infections
    • Peripheral neuropathy.

    Measured: From first administration of study drug until last administration of study drug + 16 weeks of follow up, up to 6.3 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2022
  2. Study start17 Feb 2022
  3. Primary completion20 Mar 2023
  4. Study completion20 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05200247
Sponsor's protocol ID
1368-0073
Status last verified
Feb 2025
First submitted
11 Jan 2022
Last updated
25 Feb 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing spesolimab in people with Generalized Pustular Psoriasis, run by Boehringer Ingelheim at 9 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of Treatment Emergent Adverse Events (TEAEs) (time frame: From first administration of study drug until last administration of study drug + 16 weeks of follow up, up to 6.3 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05200247.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.

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