Schnitzler's syndrome MedDRA version: 20.0 Level: PT Classification code 10062908 Term: Schnitzler's syndrome System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: Dapansutrile Capsules
Product Code: OLT1177 Capsules
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: dapansutrile
CAS Number: 54863-37-5
Current Sponsor code: OLT1177
Other descr
Sponsors
Olatec Therapeutics LLC
Eligibility
Sex/Gender
All
Inclusion 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 a stable dose of anakinra for at least 3 months 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 and other prohibited medications as outlined in the protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
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 or Study OLT1177-04 or Study OLT1177-05
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To assess the safety, tolerability, and pharmacokinetics of dapansutrile capsules after oral administration in subjects with chronic, well-controlled Schnitzler’s syndrome ;Secondary Objective: - To assess the clinical activity of dapansutrile capsules, including the change in symptoms of Schnitzler’s syndrome, upon withdrawal of anakinra therapy - To assess the pharmacodynamics and changes in inflammatory biomarkers after oral administration of dapansutrile capsules, upon withdrawal of anakinra therapy, and after all therapy has ended ;Primary end point(s): The primary endpoints are those related to the safety objective of the study, specifically: - Physical examination (abbreviated general and site specific examination) - Vital Signs (pulse, resting blood pressure, temperature, respiration rate) - Safety laboratory measures (chemistry, hematology, urinalysis and CRP) - Adverse Events (AEs) during the clinical trial ;Timepoint(s) of evaluation of this end point: - Physical examination: Screening/Baseline (Day 1), Day 14 (targeted), Day 21 (targeted) and Symptom Onset (targeted) visits - Vital Signs: Screening/Baseline (Day 1), Day 5, Day 9, Day 14, Day 15, Day 16, Day 18, Day 21 and Symptom Onset visits - Safety laboratory measures: Screening/Baseline (Day 1), Day 5, Day 9, Day 14, Day 21 and Symptom Onset Visits - Adverse Events: throughout the clinical trial until Day 42 or resolution | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The proportion of subjects with Grade 0 or 1 SchS symptoms at the Day 14 visit (primary efficacy outcome) - Photographs of the posterior torso and/or other non-identifying areas of the body that display(ed) urticarial rash at Baseline - Investigator Global Assessment of Disease Activity (5-point NRS) - Subject Global Assessment of Disease Activity (11-point NRS; by diary) - Subject Skin Assessment (5-point NRS; by diary) - Ear (tympanic) body temperature measurements (by diary) - Subject Global Evaluation of Treatment - Pharmacodynamics (PD) biomarkers - Pharmacokinetics (PK; plasma concentration of dapansutrile);Timepoint(s) of evaluation of this end point: - Grade 0 or 1 SchS symptoms: composite index - Photographs: Screening/Day 1, Days 5, 9, 14, 21 and Symptom Onset (SOV) visits; and Day 15, 16 and 18 if in-clinic visits - Inv. Global Assessment of Disease Activity: Screening/Day 1, Days 5, 9, 14, 21 and SOV; and Day 15, 16 and 18 if in-clinic visits - Subject Global Asmt of Disease Activity: by diary; daily from Day 1 until SOV or Day 21 visit (whichever occurs latest) - Subject Skin Asmt: by diary; daily from Day 1 until SOV or Day 21 visit (whichever occurs latest) - Body temp: by diary; daily from Day 1 until SOV or Day 21 visit (whichever occurs latest) - Subject Global Eval of Treatment: Day 14 - PD: Screening/Day 1, Days 5, 9, 14, 15, 16, 18 21 and SOV visits - PK: Screening/Day 1, Days 5, 9, 14, 15,16, 18, 21and SOV visits | — |
Countries
Netherlands
Contacts
Public ContactClinical Trials Inquiries
Olatec Therapeutics
Outcome results
None listed