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    EudraCT Number:2017-003282-98
    Sponsor's Protocol Code Number:OLT1177-07
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-01-16
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2017-003282-98
    A.3Full title of the trial
    A Pilot, Open-Label, Phase 2, Single-Center, Repeat Dose, Proof-of-Concept Safety, Pharmacodynamics and Efficacy Study of Orally Administered Dapansutrile Capsules in Subjects with Schnitzler’s Syndrome
    Een Pilot, Open-Label, Phase 2, Single-Center, Repeat Dose, Proof-of-Concept Safety naar Farmacodynamiek en Efficacy van Oraal Toegediende Dapansutrile Capsules bij Patiënten met het syndroom van Schnitzler
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pilot Study of Dapansutrile Capsules in Schnitzler’s Syndrome
    Pilot studie naar het gebruik van dapansutrile capsules bij het syndroom van Schnitzler
    A.4.1Sponsor's protocol code numberOLT1177-07
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorOlatec Therapeutics LLC
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportOlatec Therapeutics LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOlatec Therapeutics
    B.5.2Functional name of contact pointClinical Trials Inquiries
    B.5.3 Address:
    B.5.3.1Street Address800 Fifth Avenue, Suite 25D
    B.5.3.2Town/ cityNew York, NY
    B.5.3.3Post code10065
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1833652 8321
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDapansutrile Capsules
    D.3.2Product code OLT1177 Capsules
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdapansutrile
    D.3.9.1CAS number 54863-37-5
    D.3.9.2Current sponsor codeOLT1177
    D.3.9.3Other descriptive nameDAPANSUTRILE
    D.3.9.4EV Substance CodeSUB184700
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Schnitzler's syndrome
    Syndroom van Schnitzler
    E.1.1.1Medical condition in easily understood language
    Schnitzler's syndrome
    Syndroom van Schnitzler
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10062908
    E.1.2Term Schnitzler's syndrome
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To assess the safety, tolerability, and pharmacokinetics of dapansutrile capsules after oral administration in subjects with chronic, well-controlled Schnitzler’s syndrome
    E.2.2Secondary objectives of the trial
    - 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
    E.2.3Trial contains a sub-study No
    E.3Principal 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.
    E.4Principal 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
    E.5 End points
    E.5.1Primary 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
    E.5.1.1Timepoint(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
    E.5.2Secondary 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)
    E.5.2.1Timepoint(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
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS (telephone follow-up visit)
    LVLS (telefoon contact)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 10
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After the subject has complete the study, he/she will return to their standard of care therapy (specifically anakinra) and will return to the care of his/her primary care provider.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-01-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-07
    P. End of Trial
    P.End of Trial StatusOngoing
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