Status:
TERMINATED
A Study to Test Long-term Treatment With Spesolimab in People With Palmoplantar Pustulosis (PPP) Who Took Part in Previous Studies With Spesolimab
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Palmoplantar Pustulosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is open to people with palmoplantar pustulosis who took part in previous clinical studies of a medicine called spesolimab. Participants who benefited from spesolimab treatment in the previo...
Eligibility Criteria
Inclusion
- Signed and dated written informed consent for the current trial 1368-0024, 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 in one of the parent trials without premature discontinuation
- Patients who have obtained an individual health benefit, per investigator judgement (e.g. PPP PGA of 0 (clear) or 1 (almost clear) or other clinical improvement), from treatment in the parent 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
Exclusion
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial
- Patients who experienced study treatment-limiting adverse events during the parent trial
- Severe, progressive, or uncontrolled condition such as renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof
- Patients with congestive heart disease, as assessed by the investigator
- Patient with a transplanted organ (with exception of a corneal transplant \> 12 weeks prior to screening in parent trial) or who have ever received stem cell therapy (e.g., Prochymal)
- Known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease (e.g. splenomegaly)
- Any documented active or suspected malignancy or history of 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
- Patients who have developed active or severe infective disease and opportunistic infections/infective diseases
- Further exclusion criteria apply
Key Trial Info
Start Date :
September 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2023
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT04493424
Start Date
September 4 2020
End Date
May 15 2023
Last Update
October 17 2025
Active Locations (66)
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1
Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, United States, 35205
2
University of Missouri Health System
Columbia, Missouri, United States, 65212
3
The Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, United States, 08520
4
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213