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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03886246
Recruitment Status : Recruiting
First Posted : March 22, 2019
Last Update Posted : February 19, 2020
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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
Generalized Pustular Psoriasis Drug: Spesolimab Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 171 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
Estimated Primary Completion Date : August 19, 2027
Estimated Study Completion Date : December 9, 2027


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




Primary Outcome Measures :
  1. Occurrence of treatment emergent adverse events (TEAEs) up to week 252 of maintenance treatment [ Time Frame: Up to 252 Weeks ]

Secondary Outcome Measures :
  1. The reoccurrence of a GPP flare defined by GPPGA [ Time Frame: Up to 252 Weeks ]
  2. Time to first achievement of a GPPGA score of 0 or 1 (Patients received flare rescue Treatment) [ Time Frame: Up to 252 Weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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 651330 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.
  • Further exclusion criteria apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03886246


Contacts
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Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
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United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Mark Lebwohl    +001 (212) 844-3288    mark.lebwohl@mountsinai.org   
France
HOP Saint-Louis Recruiting
Paris, France, 75010
Contact: Hervé Bachelez    +33 (0)1 42 49 98 17    herve.bachelez@aphp.fr   
HOP Robert Debré Recruiting
Reims, France, 51092
Contact: Manuelle-Anne Viguier    +33 (0)3 26 78 43 43    mviguier@chu-reims.fr   
Germany
Charité - Universitätsmedizin Berlin Recruiting
Berlin, Germany, 10117
Contact: Kamran Ghoreschi    +49 (30) 450 518 062    kamran.ghoreschi@charite.de   
Klinikum der Universität München - Campus Innenstadt Recruiting
München, Germany, 80337
Contact: Franziska Rueff    +49 (89) 440056661    Franziska.Rueff@med.uni-muenchen.de   
Malaysia
Hospital Sultanah Aminah Active, not recruiting
Johor Bahru, Malaysia, 80100
Hospital Sultan Ismail Active, not recruiting
Johor Bahru, Malaysia, 81100
Hospital Pakar Sultanah Fatimah Active, not recruiting
Muar, Malaysia, 84000
Taiwan
National Taiwan University Hospital Active, not recruiting
Taipei, Taiwan, 10002
Thailand
Ramathibodi Hospital Recruiting
Bangkok, Thailand, 10400
Contact: Natta Rajatanavin    +66 2 2011211    natta.rama@gmail.com   
Sponsors and Collaborators
Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03886246    
Other Study ID Numbers: 1368-0025
2018-003080-56 ( EudraCT Number )
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

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, except for the following exclusions:

  1. Studies in products where Boehringer Ingelheim is not the license holder;
  2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;
  3. Studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).

Requestors can use the following link http:// trials.boehringer-ingelheim.com/ to:

  1. find information in order to request access to clinical study data, for listed studies.
  2. request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases