Pilot Study of Dapansutrile Capsules in Schnitzler's Syndrome

• Status: Recruiting
• Trial end date: 2023-02-28
• Target enrollment: 0
• Participant gender: All

Summary

This is a pilot, open-label Phase 2, single-center, repeat dose, single cohort, proof-of-concept, safety, pharmacodynamics and efficacy study of dapansutrile capsules to be conducted in subjects with Schnitzler's syndrome (SchS) currently well controlled by anakinra therapy. At least 5 but no more than 10 subjects will be enrolled.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Olatec Therapeutics LLC
• Collaborator: Radboud University
• Treatments: Dapansutrile

Criteria

Inclusion Criteria:

1. Male and female subjects 18 years old or older

2. Prior diagnosis of Schnitzler's syndrome

3. Presence of Schnitzler's syndrome that is well controlled by and responsive to anakinra for at least 6 weeks prior to the Screening/Baseline visit

4. Grade 0 SchS symptoms at the Screening/Baseline visit

5. Acceptable overall medical condition to be safely enrolled in and to complete the study (with specific regard to cardiovascular, renal and hepatic conditions) in the opinion of the Investigator

6. Ability to provide written informed consent prior to initiation of any study-related procedures, and ability, in the opinion of the Investigator, to understand and comply with all the requirements of the study as outlined in the protocol.

Exclusion Criteria:

1. Pregnant, nursing or intent to become pregnant during the study

2. Not responsive or well controlled by anakinra therapy for at least 6 weeks prior to the Screening/Baseline visit

3. Use or planned use of any prohibited concomitant medications/therapies such as immunotherapies or corticosteroids during the study (until relapse and resumption of anakinra injections)

4. Active infection within 3 days prior to the Screening/Baseline visit

5. History of or known positive for HIV, Hepatitis B surface antigen (HBsAg) or antibodies to Hepatitis C Virus (HCV)

6. Any other concomitant medical or psychiatric conditions, including alcohol or substance abuse, diseases or prior surgeries that in the opinion of the Investigator would impair the subject from safely participating in the trial and/or completing protocol requirements

7. Enrollment in any trial and/or use of any investigational product or device within the immediate 30-day period prior to the Screening/Baseline visit

8. Enrollment in any study previously sponsored by Olatec Therapeutics LLC, specifically Study OLT1177-01, Study OLT1177-02, Study OLT1177-03, Study OLT1177-04 or Study OLT1177-05