A Study Investigating Long-term Treatment With Spesolimab in People With a Skin Disease Called Hidradenitis Suppurativa Who Completed a Previous Clinical Trial

Overview

About this study

The primary objective of this trial is to assess the long-term safety of spesolimab in patients with HS who have completed the 1368-0052 PoCC trial and are qualified for entry into this trial. The secondary objectives are to evaluate effectiveness at a lower dose than tested in PoCC trial.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Patients who have completed treatment in the parent HS spesolimab trial (1368-0052) without premature discontinuation.
  • Signed and dated written informed consent in accordance with ICH Harmonized Guideline for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
  • WOCBP1 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 the patient information and consent form.

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 new documented active or suspected malignancy except appropriately treated basal cell carcinoma, squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.
  • Use of any restricted medication or any drug considered by the investigator likely to interfere with the safe conduct of the study since the last visit of the 1368-0052 parent trial.
  • History of allergy/hypersensitivity to the systemically administered trial medication agent or its excipients.
  • Major surgery (major according to the investigator’s assessment) planned during this extension trial (e.g., hip replacement, aneurysm removal, stomach ligation), as assessed by the investigator.
  • 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).
  • Currently enrolled in another investigational device or drug trial, except for 1368-0052.
  • Previous participation in this trial.

Eligibility last updated 9/10/21. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Afsaneh Alavi, M.D.

Closed for enrollment

Contact information:

Gabrielle Klemme

(507) 266-7838

Klemme.Gabrielle@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20521960

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