An open-label, long-term extension trial of spesolimab treatment in adult patients with Hidradenitis Suppurativa (HS)

Phase 2

Completed

• Conditions: a skin disease called hidradenitis suppurativa; Verneuil's disease; 10040798

• Registration Number: NL-OMON56233
• Lead Sponsor: IQVIA RDS Netherlands B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 3

Inclusion Criteria

- Patients who have completed treatment in the parent HS spesolimab trial
(1368-0052) without premature discontinuation.

Exclusion Criteria

- 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
1368-0052 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.
- Any condition which in the opinion of the investigator affects the safety of
the patient, the patient's ability to participate in this trial or could
compromise the quality of data.
- Any suicidal behaviour in the past 2 years (i.e. actual attempt, interrupted
attempt, aborted attempt, or preparatory acts or behaviour).
- Any suicidal ideation of type 4 or 5 on the C-SSRS in the past 3 months (i.e.
active suicidal thoughts with method and intent but without specific plan, or
active suicidal thoughts with method, intent and plan).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the occurrence of treatment emergent adverse events<br /><br>(TEAEs) up to the end of the maintenance treatment period including REP (i.e.,<br /><br>16 weeks after the last study treatment).</p><br>