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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 12 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

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 4.2.2.3 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03886246
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Boehringer Ingelheim
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Argentina, Belgium, Chile, China, France, Germany, Italy, Japan, Korea, Republic of, Malaysia, Philippines, Russian Federation, Spain, Taiwan, Thailand, Tunisia, Turkey, United States, Vietnam
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Generalized Pustular Psoriasis
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Spesolimab (every 6 weeks)

Experimental: Spesolimab (every 12 weeks)

Experimental: Spesolimab (every 4 weeks)

Interventions

Drug: - Spesolimab

Solution for infusion

Drug: - Spesolimab

Solution for injection

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Oakland Hills Dermatology, Auburn Hills, Michigan

Status

Terminated

Address

Oakland Hills Dermatology

Auburn Hills, Michigan, 48326

Icahn School of Medicine at Mount Sinai, New York, New York

Status

Recruiting

Address

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

Site Contact

Boehringer Ingelheim

[email protected]

833-602-2368

International Sites

Hospital Italiano de Buenos Aires, Caba, Argentina

Status

Recruiting

Address

Hospital Italiano de Buenos Aires

Caba, , C1199ABD

Site Contact

Boehringer Ingelheim

[email protected]

08002667801

Brussels - UNIV Saint-Luc, Bruxelles, Belgium

Status

Recruiting

Address

Brussels - UNIV Saint-Luc

Bruxelles, , 1200

Site Contact

Boehringer Ingelheim

[email protected]

080049616

Clínica Dermacross S.A., Vitacura, Chile

Status

Recruiting

Address

Clínica Dermacross S.A.

Vitacura, , 7640881

Site Contact

Boehringer Ingelheim

[email protected]

800392345

Hangzhou, China

Status

Recruiting

Address

2nd Affiliated Hosp Zhejiang University College of Medical

Hangzhou, , 310009

Site Contact

Boehringer Ingelheim

[email protected]

4001200553

Shanghai Skin Disease Hospital, Shanghai, China

Status

Recruiting

Address

Shanghai Skin Disease Hospital

Shanghai, , 200000

Site Contact

Boehringer Ingelheim

[email protected]

4001200553

Huashan Hospital, Fudan University, Shanghai, China

Status

Recruiting

Address

Huashan Hospital, Fudan University

Shanghai, , 200040

Site Contact

Boehringer Ingelheim

[email protected]

4001200553

Xi'An, China

Status

Recruiting

Address

Second Affiliated Hospital of Xi'an JiaoTong University

Xi'An, , 710004

Site Contact

Boehringer Ingelheim

[email protected]

4001200553

HOP Saint-André, Bordeaux, France

Status

Recruiting

Address

HOP Saint-André

Bordeaux, , 33000

Site Contact

Boehringer Ingelheim

[email protected]

0805102354

HOP l'Archet, Nice, France

Status

Recruiting

Address

HOP l'Archet

Nice, , 06200

Site Contact

Boehringer Ingelheim

[email protected]

0805102354

HOP Saint-Louis, Paris, France

Status

Recruiting

Address

HOP Saint-Louis

Paris, , 75010

Site Contact

Boehringer Ingelheim

[email protected]

0805102354

HOP Robert Debré, Reims, France

Status

Recruiting

Address

HOP Robert Debré

Reims, , 51092

Site Contact

Boehringer Ingelheim

[email protected]

0805102354

Fachklinik Bad Bentheim, Bad Bentheim, Germany

Status

Recruiting

Address

Fachklinik Bad Bentheim

Bad Bentheim, , 48455

Site Contact

Boehringer Ingelheim

[email protected]

08007234742

Charité - Universitätsmedizin Berlin, Berlin, Germany

Status

Recruiting

Address

Charité - Universitätsmedizin Berlin

Berlin, , 10117

Site Contact

Boehringer Ingelheim

[email protected]

08007234742

Universitätsklinikum Bonn AöR, Bonn, Germany

Status

Recruiting

Address

Universitätsklinikum Bonn AöR

Bonn, , 53127

Site Contact

Boehringer Ingelheim

[email protected]

08007234742

Universitätsklinikum Frankfurt, Frankfurt am Main, Germany

Status

Recruiting

Address

Universitätsklinikum Frankfurt

Frankfurt am Main, , 60596

Site Contact

Boehringer Ingelheim

[email protected]

08007234742

München, Germany

Status

Recruiting

Address

Klinikum der Universität München - Campus Innenstadt

München, , 80337

Site Contact

Boehringer Ingelheim

[email protected]

08007234742

Universitätsklinikum Münster, Münster, Germany

Status

Recruiting

Address

Universitätsklinikum Münster

Münster, , 48149

Site Contact

Boehringer Ingelheim

[email protected]

08007234742

Klinikum Oldenburg AöR, Oldenburg, Germany

Status

Recruiting

Address

Klinikum Oldenburg AöR

Oldenburg, , 26133

Site Contact

Boehringer Ingelheim

[email protected]

08007234742

Istituto Clinico Humanitas, Rozzano (MI), Italy

Status

Recruiting

Address

Istituto Clinico Humanitas

Rozzano (MI), , 20089

Site Contact

Boehringer Ingelheim

[email protected]

800977373

Nagoya City University Hospital, Aichi, Nagoya, Japan

Status

Active, not recruiting

Address

Nagoya City University Hospital

Aichi, Nagoya, , 467-8602

Ibaraki, Inashiki-gun, Japan

Status

Active, not recruiting

Address

Tokyo Medical University Ibaraki Medical Center

Ibaraki, Inashiki-gun, , 300-0395

Tokyo, Hachioji, Japan

Status

Active, not recruiting

Address

Tokyo Medical University Hachioji Medical Center

Tokyo, Hachioji, , 193-0998

Severance Hospital, Seoul, Korea, Republic of

Status

Active, not recruiting

Address

Severance Hospital

Seoul, , 03722

Hospital Pulau Pinang, George Town, Malaysia

Status

Active, not recruiting

Address

Hospital Pulau Pinang

George Town, , 10990

Hospital Sultanah Aminah, Johor Bahru, Malaysia

Status

Active, not recruiting

Address

Hospital Sultanah Aminah

Johor Bahru, , 80100

Hospital Sultan Ismail, Johor Bahru, Malaysia

Status

Active, not recruiting

Address

Hospital Sultan Ismail

Johor Bahru, , 81100

Queen Elizabeth Hospital, Kota Kinabalu, Malaysia

Status

Recruiting

Address

Queen Elizabeth Hospital

Kota Kinabalu, , 88586

Site Contact

Boehringer Ingelheim

[email protected]

1800814353

Hospital Kuala Lumpur, Kuala Lumpur, Malaysia

Status

Active, not recruiting

Address

Hospital Kuala Lumpur

Kuala Lumpur, , 50586

Sarawak General Hospital, Kuching, Sarawak, Malaysia

Status

Active, not recruiting

Address

Sarawak General Hospital

Kuching, Sarawak, , 93586

Hospital Pakar Sultanah Fatimah, Muar, Malaysia

Status

Active, not recruiting

Address

Hospital Pakar Sultanah Fatimah

Muar, , 84000

Hospital Raja Permaisuri Bainun, Negeri Perak/Ipoh, Malaysia

Status

Completed

Address

Hospital Raja Permaisuri Bainun

Negeri Perak/Ipoh, , 30450

Hospital Selayang, Selangor, Malaysia

Status

Completed

Address

Hospital Selayang

Selangor, , 68100

Southern Philippines Medical Center, Davao City, Philippines

Status

Recruiting

Address

Southern Philippines Medical Center

Davao City, , 8000

Site Contact

Boehringer Ingelheim

[email protected]

180084748502

Iloilo Doctors Hospital, Iloilo City, Iloilo, Philippines

Status

Recruiting

Address

Iloilo Doctors Hospital

Iloilo City, Iloilo, , 5000

Site Contact

Boehringer Ingelheim

[email protected]

180084748502

Makati City, Philippines

Status

Recruiting

Address

Center for Skin Research, Testing and Product Development

Makati City, , 1229

Site Contact

Boehringer Ingelheim

[email protected]

180084748502

SBHI Chelyabinsk Reg.Clin.Derma.Dispen., Chelyabinsk, Russian Federation

Status

Recruiting

Address

SBHI Chelyabinsk Reg.Clin.Derma.Dispen.

Chelyabinsk, , 454048

Site Contact

Boehringer Ingelheim

[email protected]

88003018773

LLC "Medical Center Azbuka Zdorovia", Kazan, Russian Federation

Status

Recruiting

Address

LLC "Medical Center Azbuka Zdorovia"

Kazan, , 420111

Site Contact

Boehringer Ingelheim

[email protected]

88003018773

Kirov, Russian Federation

Status

Recruiting

Address

FSBEI HE "Kirov State Medical University"

Kirov, , 610035

Site Contact

Boehringer Ingelheim

[email protected]

88003018773

Saratov State Med.Univ.n.a.Razumovskogo, Saratov, Russian Federation

Status

Recruiting

Address

Saratov State Med.Univ.n.a.Razumovskogo

Saratov, , 410028

Site Contact

Boehringer Ingelheim

[email protected]

88003018773

St. Petersburg, Russian Federation

Status

Recruiting

Address

LLC Skin Disease Clinic of Pier Volkenstein, St. Petersburg

St. Petersburg, , 190123

Site Contact

Boehringer Ingelheim

[email protected]

88003018773

Hospital Sant Joan de Déu, Esplugues Del Llobregat, Spain

Status

Active, not recruiting

Address

Hospital Sant Joan de Déu

Esplugues Del Llobregat, , 08950

National Taiwan University Hospital, Taipei, Taiwan

Status

Active, not recruiting

Address

National Taiwan University Hospital

Taipei, , 10002

Institute of Dermatology, Bangkok, Thailand

Status

Active, not recruiting

Address

Institute of Dermatology

Bangkok, , 10400

Ramathibodi Hospital, Bangkok, Thailand

Status

Active, not recruiting

Address

Ramathibodi Hospital

Bangkok, , 10400

Farhat Hached Hospital, Sousse, Tunisia

Status

Recruiting

Address

Farhat Hached Hospital

Sousse, , 4000

Site Contact

Boehringer Ingelheim

[email protected]

031365917

Tunisia, Tunisia

Status

Recruiting

Address

Hedi Chaker Hospital, Department of Dermatology

Tunisia, , 1053

Site Contact

Boehringer Ingelheim

[email protected]

031365917

Istanbul, Turkey

Status

Recruiting

Address

Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi

Istanbul, , 34890

Site Contact

Boehringer Ingelheim

[email protected]

08006212470

Ha Noi, Vietnam

Status

Recruiting

Address

National Hospital of Dermatology and Venereology

Ha Noi, , 10000

Site Contact

Boehringer Ingelheim

[email protected]

01800545473

HCMC Hospital of Dermato-Venereology, Ho Chi Minh, Vietnam

Status

Recruiting

Address

HCMC Hospital of Dermato-Venereology

Ho Chi Minh, , 70000

Site Contact

Boehringer Ingelheim

[email protected]

01800545473

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