Clinical Trials List
Protocol Number1368-0025
NCT Number(ClinicalTrials.gov Identfier)NCT03886246
Active
2019-06-01 - 2026-12-31
Phase III
Not yet recruiting3
Recruiting1
ICD-10L40.0
Psoriasis vulgaris
ICD-10L40.1
Generalized pustular psoriasis
ICD-10L40.2
Acrodermatitis continua
ICD-10L40.3
Pustulosis palmaris et plantaris
ICD-10L40.4
Guttate psoriasis
ICD-10L40.8
Other psoriasis
ICD-10L40.9
Psoriasis, unspecified
ICD-9696.1
Other psoriasis
An Open-label, Long Term Extension Study to Assess the Safety and Efficacy of BI 655130 Treatment in Patients With Generalized Pustular Psoriasis (GPP)
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Trial Applicant
Boehringer Ingelheim
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Sponsor
Boehringer Ingelheim
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 紀景琪 Division of Dermatology
- Chun-Wei Lu 無
- 吳吉妮 Division of Dermatology
- 王芳穎 Division of Dermatology
- Chung-Yao Hsu Division of Dermatology
- Chun-Bing Chen 無
- 陳偉迪 無
- Yu-Huei Huang Division of Dermatology
- 陳偉迪 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Chih-Chiang Chen Division of Dermatology
- 吳貞宜 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Chih-Chieh Chan Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Generalized Pustular Psoriasis (GPP)
Objectives
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
Test Drug
Spesolimab (BI 655130)
Active Ingredient
BI 655130
Dosage Form
Solution for injection (s.c.)
Solution for infusion (i.v.)
Solution for infusion (i.v.)
Dosage
150 mg/PFS (150 mg/mL), 1 mL fill volume
450 mg/vial (60 mg/mL),7.5 mL fill volume
450 mg/vial (60 mg/mL),7.5 mL fill volume
Endpoints
Primary Outcome Measures :
Occurrence of treatment emergent adverse events (TEAEs) up to week 252 of maintenance treatment [ Time Frame: Up to 252 Weeks ]
Secondary Outcome Measures :
The reoccurrence of a GPP flare defined by GPPGA [ Time Frame: Up to 252 Weeks ]
Time to first achievement of a GPPGA score of 0 or 1 (Patients received flare rescue Treatment) [ Time Frame: Up to 252 Weeks ]
A GPPGA pustulation sub-score of 0 indicating no visible pustules, by visit [ Time Frame: Up to 252 Weeks ]
Change from baseline in Psoriasis Symptom Scale (PSS) score, by visit [ Time Frame: Up to 252 Weeks ]
Occurrence of treatment emergent adverse events (TEAEs) up to week 252 of maintenance treatment [ Time Frame: Up to 252 Weeks ]
Secondary Outcome Measures :
The reoccurrence of a GPP flare defined by GPPGA [ Time Frame: Up to 252 Weeks ]
Time to first achievement of a GPPGA score of 0 or 1 (Patients received flare rescue Treatment) [ Time Frame: Up to 252 Weeks ]
A GPPGA pustulation sub-score of 0 indicating no visible pustules, by visit [ Time Frame: Up to 252 Weeks ]
Change from baseline in Psoriasis Symptom Scale (PSS) score, by visit [ Time Frame: Up to 252 Weeks ]
Inclution Criteria
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
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
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
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
The Estimated Number of Participants
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Taiwan
18 participants
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Global
120 participants
