A Study to Test Long-term Treatment With Spesolimab in People With Palmoplantar Pustulosis (PPP) Who Took Part in Previous Studies With Spesolimab
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|ClinicalTrials.gov Identifier: NCT04493424|
Recruitment Status : Recruiting
First Posted : July 30, 2020
Last Update Posted : May 19, 2022
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 previous studies can join this study.
The purpose of this study is to find out how safe spesolimab is and whether it helps people with palmoplantar pustulosis in the long-term. Participants are in this study for up to 5 years. During this time they visit the study site every month to get spesolimab injections under the skin.
At study visits, doctors check the severity of participants' palmoplantar pustulosis and collect information on any health problems of the participants.
|Condition or disease||Intervention/treatment||Phase|
|Palmoplantar Pustulosis||Drug: Spesolimab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Long Term Safety Trial of Spesolimab Treatment in Patients With Palmoplantar Pustulosis (PPP) Who Have Completed Previous BI Spesolimab Trials|
|Actual Study Start Date :||September 4, 2020|
|Estimated Primary Completion Date :||March 25, 2029|
|Estimated Study Completion Date :||July 25, 2029|
Experimental: Treatment group
Up to 260 weeks
- Occurrence of treatment emergent adverse events (TEAEs) [ Time Frame: Up to week 260 ]
- Percent change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) from baseline in parent trial [ Time Frame: Up to week 260 ]
- Proportion of patients with Palmoplantar Pustulosis Area and Severity Index 50% (PPP ASI50) compared to baseline in parent trial [ Time Frame: Up to week 260 ]
- Proportion of patients with Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) of 0 (clear) or 1 (almost clear) [ Time Frame: Up to week 260 ]
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): NCT04493424
|Contact: Boehringer Ingelheimfirstname.lastname@example.org|