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A 5-year Study to Test BI 655130 in Patients With Generalized Pustular Psoriasis Who Took Part in Previous Studies With BI 655130

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03886246
Collaborator
(none)
155
Enrollment
50
Locations
3
Arms
103.8
Anticipated Duration (Months)
3.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the long-term safety and efficacy of BI 655130 in patients with GPP, who have completed previous BI 655130 trials and are qualified for entry in this trial

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
155 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label, Long Term Extension Study to Assess the Safety and Efficacy of BI 655130 Treatment in Patients With Generalized Pustular Psoriasis (GPP)
Actual Study Start Date :
May 27, 2019
Anticipated Primary Completion Date :
Sep 30, 2027
Anticipated Study Completion Date :
Jan 20, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: Spesolimab (every 6 weeks)

Drug: Spesolimab
Solution for infusion

Drug: Spesolimab
Solution for injection
Experimental: Spesolimab (every 12 weeks)

Drug: Spesolimab
Solution for injection
Experimental: Spesolimab (every 4 weeks)

Drug: Spesolimab
Solution for injection

Outcome Measures

Primary Outcome Measures

  1. Occurrence of treatment emergent adverse events (TEAEs) up to week 252 of maintenance treatment [Up to 252 Weeks]

Secondary Outcome Measures

  1. The reoccurrence of a GPP flare defined by GPPGA [Up to 252 Weeks]

  2. Time to first achievement of a GPPGA score of 0 or 1 (Patients received flare rescue Treatment) [Up to 252 Weeks]

  3. A GPPGA pustulation sub-score of 0 indicating no visible pustules, by visit [Up to 252 Weeks]

  4. Change from baseline in Psoriasis Symptom Scale (PSS) score, by visit [Up to 252 Weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Male or female patients who have completed the treatment period without premature discontinuation in the previous BI 655130 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:

  • Treatment with any restricted medication, or any drugs considered by the investigator likely to interfere with the safe conduct of the study since the last visit of the previous BI 655130 trial and during the screening period for the current trial

  • Severe, progressive, or uncontrolled hepatic disease, defined as >3- fold Upper Limit of Normal (ULN) elevation in AST or 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.

  • 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.

  • 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 up to 16 weeks after the study drug administration

  • Major surgery (major according to the investigator's assessment) performed since the last visit of previous BI 655130 trial or planned during the current trial, e.g. hip replacement, aneurysm removal, stomach ligation), as assessed by the investigator.

  • Evidence of a current or previous disease, medical condition (including chronic alcohol or drug abuse or any condition) other than GPP, surgical procedure, psychiatric or social problems, medical examination finding (including vital signs and electrocardiogram [ECG]), or laboratory value at the screening outside the reference range that in the opinion of the investigator is clinically significant and would make the study participant unreliable to adhere to the protocol, comply with all study visits/procedures or to complete the trial, compromise the safety of the patient or compromise the quality of the data.

  • Patients with a confirmed active infection with SARS-CoV-2 (as confirmed by PCR test). A patient may be enrolled once recovered from SARS-CoV-2 infection according to the investigator's assessment.

  • Further exclusion criteria apply

Contacts and Locations

Locations

Site City State Country Postal Code
1 Oakland Hills Dermatology Auburn Hills Michigan United States 48326
2 Icahn School of Medicine at Mount Sinai New York New York United States 10029
3 Hospital Italiano de Buenos Aires Caba Argentina C1199ABD
4 Brussels - UNIV Saint-Luc Bruxelles Belgium 1200
5 Clínica Dermacross S.A. Vitacura Chile 7640881
6 2nd Affiliated Hosp Zhejiang University College of Medical Hangzhou China 310009
7 Shanghai Skin Disease Hospital Shanghai China 200000
8 Huashan Hospital, Fudan University Shanghai China 200040
9 Second Affiliated Hospital of Xi'an JiaoTong University Xi'An China 710004
10 HOP Saint-André Bordeaux France 33000
11 HOP l'Archet Nice France 06200
12 HOP Saint-Louis Paris France 75010
13 HOP Robert Debré Reims France 51092
14 Fachklinik Bad Bentheim Bad Bentheim Germany 48455
15 Charité - Universitätsmedizin Berlin Berlin Germany 10117
16 Universitätsklinikum Bonn AöR Bonn Germany 53127
17 Universitätsklinikum Frankfurt Frankfurt am Main Germany 60596
18 Klinikum der Universität München - Campus Innenstadt München Germany 80337
19 Universitätsklinikum Münster Münster Germany 48149
20 Klinikum Oldenburg AöR Oldenburg Germany 26133
21 Istituto Clinico Humanitas Rozzano (MI) Italy 20089
22 Nagoya City University Hospital Aichi, Nagoya Japan 467-8602
23 Tokyo Medical University Ibaraki Medical Center Ibaraki, Inashiki-gun Japan 300-0395
24 Tokyo Medical University Hachioji Medical Center Tokyo, Hachioji Japan 193-0998
25 Severance Hospital Seoul Korea, Republic of 03722
26 Hospital Pulau Pinang George Town Malaysia 10990
27 Hospital Sultanah Aminah Johor Bahru Malaysia 80100
28 Hospital Sultan Ismail Johor Bahru Malaysia 81100
29 Queen Elizabeth Hospital Kota Kinabalu Malaysia 88586
30 Hospital Kuala Lumpur Kuala Lumpur Malaysia 50586
31 Sarawak General Hospital Kuching, Sarawak Malaysia 93586
32 Hospital Pakar Sultanah Fatimah Muar Malaysia 84000
33 Hospital Raja Permaisuri Bainun Negeri Perak/Ipoh Malaysia 30450
34 Hospital Selayang Selangor Malaysia 68100
35 Southern Philippines Medical Center Davao City Philippines 8000
36 Center for Skin Research, Testing and Product Development Makati City Philippines 1229
37 SBHI Chelyabinsk Reg.Clin.Derma.Dispen. Chelyabinsk Russian Federation 454048
38 LLC "Medical Center Azbuka Zdorovia" Kazan Russian Federation 420111
39 FSBEI HE "Kirov State Medical University" Kirov Russian Federation 610035
40 Saratov State Med.Univ.n.a.Razumovskogo Saratov Russian Federation 410028
41 LLC Skin Disease Clinic of Pier Volkenstein, St. Petersburg St. Petersburg Russian Federation 190123
42 Hospital Sant Joan de Déu Esplugues Del Llobregat Spain 08950
43 National Taiwan University Hospital Taipei Taiwan 10002
44 Institute of Dermatology Bangkok Thailand 10400
45 Ramathibodi Hospital Bangkok Thailand 10400
46 Farhat Hached Hospital Sousse Tunisia 4000
47 Hedi Chaker Hospital, Department of Dermatology Tunisia Tunisia 1053
48 Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi Istanbul Turkey 34890
49 National Hospital of Dermatology and Venereology Ha Noi Vietnam 10000
50 HCMC Hospital of Dermato-Venereology Ho Chi Minh Vietnam 70000

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT03886246
Other Study ID Numbers:
  • 1368-0025
  • 2018-003080-56
First Posted:
Mar 22, 2019
Last Update Posted:
Aug 23, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Psoriasis

Study Results

No Results Posted as of Aug 23, 2022