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    Summary
    EudraCT Number:2018-004176-35
    Sponsor's Protocol Code Number:RIST4721-201
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-01-02
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2018-004176-35
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Palmoplantar Pustulosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Palmoplantar Pustulosis
    A.4.1Sponsor's protocol code numberRIST4721-201
    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 SponsorAristea Therapeutics Inc.
    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 supportAristea Therapeutics Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationbioskin GmbH
    B.5.2Functional name of contact pointClinical Trial Manager
    B.5.3 Address:
    B.5.3.1Street AddressBurchardstr 17
    B.5.3.2Town/ cityGamburg
    B.5.3.3Post code20095
    B.5.3.4CountryGermany
    B.5.4Telephone number00494060689744
    B.5.5Fax number00494060689730
    B.5.6E-mailkarolin.boecker@bioskinCRO.com
    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.3.2Product code RIST4721
    D.3.4Pharmaceutical form Oral solution
    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 INNRIST4721
    D.3.9.1CAS number 1418112-77-2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number to 9
    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.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral solution
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Palmoplantar Pustulosis
    E.1.1.1Medical condition in easily understood language
    Palmoplantar Pustulosis
    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 LLT
    E.1.2Classification code 10050185
    E.1.2Term Palmoplantar pustulosis
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is:
    • To assess the efficacy of RIST4721 versus placebo in adult subjects with moderate to severe palmoplantar pustulosis (PPP) using a range of efficacy endpoints
    E.2.2Secondary objectives of the trial
    The secondary objective is:
    • To assess the safety of RIST4721 versus placebo in adult subjects with moderate to severe PPP
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, a subject must meet all of the following criteria at the screening and Day –1 visits, unless specified otherwise:
    1. Male or female subject, aged 18–70 years at the time of consent.
    2. Subject has at least a 6-month history of PPP as defined by the presence of pustules on palms and/or soles, but without evidence of infection on palms and soles (information obtained from medical chart or subject’s physician, or directly from the subject).
    3. Subject has moderate or severe PPP, as defined by PPPASI ≥8 and PPPGA ≥3 at Day –1, and a minimum of 8 fresh pustules at screening (fresh pustule count on both right/left palms and soles) and 20 fresh pustules at Day –1 (fresh pustule count on both right/left palms and soles).
    4. Subject who wants to use an emollient should agree to use the same emollient, at the same frequency of application for 7 days before Day –1 and throughout the study. Note: However, on the day of scheduled visits, subjects cannot apply emollient before their scheduled visit time.
    5. For female subject of childbearing potential involved in any sexual intercourse that could lead to pregnancy: the subject must agree to use a highly effective contraceptive method, from at least 4 weeks before Day –1 until at least 4 weeks after the last study drug administration. Highly effective contraceptive methods include hormonal contraceptives (combined oral contraceptive, patch, vaginal ring, injectable, or implant), intrauterine devices or intrauterine systems, male partner(s) vasectomy, tubal ligation, or a double-barrier method of contraception (barrier methods include male condom, female condom, cervical cap, diaphragm, and contraceptive sponge) in conjunction with spermicide. Note: Subjects who are on a hormonal contraceptive must have been on a stable dose for at least 4 weeks before Day –1. Note: The above list of contraceptive methods does not apply to subjects who are abstinent for at least 4 weeks before Day –1 and will continue to be abstinent from penile - vaginal intercourse throughout the study. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant.
    Note: For countries where double-barrier methods are not accepted as highly effective contraception, then this option must not be considered. Note: A female of nonchildbearing potential is defined as follows: – Female who has had surgical sterilization (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy). – Female who has had a cessation of menses for at least 12 months without an alternative medical cause, and a follicle-stimulating hormone (FSH) test confirming nonchildbearing potential (refer to laboratory reference ranges for confirmatory levels).
    6. Female subject of childbearing potential has a negative serum pregnancy test at screening and negative urine pregnancy test at Day –1.
    7. Female subject agrees to not have egg retrieval during the study and for 1 month after the last study drug administration.
    8. Male subject agrees to use condom and spermicide from Day –1 until at least 3 months after the last study drug administration.
    9. Male subject agrees not to donate sperm during the study and for 3 months after the last study drug administration.
    10. Subject has negative tuberculosis (TB) infection test. Subject will be evaluated for latent TB infection with a purified protein derivative (PPD) test or a QuantiFERON-TB Gold test, if one has not been performed in the last 6 months. Subjects who demonstrate evidence of latent TB infection (either PPD ≥5 mm of induration or positive QuantiFERON-TB Gold test, irrespective of bacille Calmette-Guérin vaccination status) will not be allowed to participate in the study. Subjects with documented completed treatment for latent TB will be allowed to participate in the study without retesting.
    11. Subject must be capable of giving written informed consent, which must be personally signed and dated by the subject and obtained prior to any trial-related activities.
    12. Subject must be willing to comply with all study procedures and must be available for the duration of the study.
    E.4Principal exclusion criteria
    1. Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
    2. In the opinion of the investigator performing the initial examination, the subject should not participate in the trial (eg, due to probable noncompliance or inability to understand the nature, meaning, and consequences of the trial, and give adequately informed consent).
    3. Subject has evidence of erythrodermic, generalized pustular psoriasis, predominantly guttate psoriasis, or drug induced psoriasis.
    4. Subject has a history of skin disease or presence of skin condition (except psoriasis) that, in the opinion of the investigator, would interfere with the study assessments.
    5. Subject has moderate to severe psoriasis, as defined by plaque psoriasis covering ≥10% of his/her total BSA at Day –1.
    6. Subject is known to have immune deficiency or is immunocompromised.
    7. Subject has a history of cancer or lymphoproliferative disease within 5 years prior to Day –1. Subjects with successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or successfully treated localized carcinoma in situ of the cervix are not to be excluded.
    8. Subject had a major surgery within 8 weeks prior to Day –1 or has a major surgery planned during the study.
    9. Subject has any clinically significant medical condition or ECG/physical/laboratory/vital signs abnormality that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results.
    10. Subject has positive results for hepatitis B surface antigens (HBsAg), antibodies to hepatitis B core antigens (anti-HBc), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
    11. Any clinically significant history of infection (except for localized herpes simplex) within 4 weeks prior to Day –1.
    12. Subject has absolute neutrophil count 1.8 x 109/L at screening.
    13. Subject has ALT, AST or total bilirubin values ≥2 times the upper limit of normal (ULN), or other clinical evidence of significant hepatic impairment (eg, ascites, peri-umbilical veins, oesophageal varices) at screening.
    14. Subject has a history of clinically significant anemia or Hgb value ≤10 g/dL at screening.
    15. Subject has a creatinine clearance ≤60 ml/min at screening (calculated with MDRD formula).
    16. Subject has used any topical medication to treat PPP, including corticosteroids, retinoids, vitamin D analogues (such as calcipotriol), or tar, within 2 weeks prior to Day –1.
    17. Subject has used topical dapsone within 2 weeks prior to Day –1.
    19. Subject has used strong systemic cytochrome P450 3A4/5 inhibitors or inducers within 4 weeks or 5 half-lives, whichever is longer, prior to baseline (Day –1) (topical cytochrome P450 3A4/5 inducers or inhibitors with known limited systemic availability may be permitted). Examples of strong systemic cytochrome P450 3A4/5 inhibitors or inducers are provided in Table 3.
    20. Subject has received any UV-B phototherapy (including tanning beds) or excimer laser within 4 weeks prior to Day –1.
    21. Subject has had PUVA treatment within 4 weeks prior to Day –1. 22. Subject has received any marketed or investigational biological agent within 12 weeks or 5 half-lives (whichever is longer) prior to Day –1.
    23. Subject is currently receiving a nonbiological investigational product or investigational device or has received one within 4 weeks prior to Day –1.
    24. Subject had excessive sun exposure or has used tanning booths within 4 weeks prior to Day –1, or subject is planning a trip where excessive sun exposure is expected, or is not willing to minimize natural and artificial sunlight exposure during the study. Use of sunscreen products and protective apparel are recommended when exposure cannot be avoided.
    25. Subject has a known or suspected allergy to RIST4721 or any component of the study drug.
    26. Subject has a known history of clinically significant drug or alcohol abuse in the last year prior to Day –1.
    27. Close affiliation with the investigator (eg, a close relative), including any study staff of the sites or persons working at the CRO or subject is an employee of sponsor.
    28. Subject is institutionalized because of legal or regulatory order.
    29. For subjects consenting to biopsies only: – Subject has a history of an allergic reaction or significant sensitivity to lidocaine or other local anesthetics. – Subject has a history of hypertrophic scarring or keloid formation in scars or suture sites. – Subject has taken anticoagulant medication, such as heparin, LMW heparin, warfarin, antiplatelets (except low-dose aspirin, which will be allowed), within 2 weeks prior to Day –1, or has a contraindication to skin biopsies. NSAIDs will not be considered antiplatelets and will be allowed.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoints:
    • Relative change from baseline in fresh pustule count at Day 28
    • Relative change from baseline in total pustule count at Day 28
    E.5.1.1Timepoint(s) of evaluation of this end point
    EOT
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints:
    • Absolute change from baseline in fresh pustule count at Day 28
    • Absolute change from baseline in total pustule count at Day 28
    • Proportion of subjects achieving at least a 50% reduction in fresh pustule count at Day 28
    • Proportion of subjects achieving at least a 50% reduction in total pustule count at Day 28
    Secondary Safety Endpoints:
    • Incidence of TEAEs
    • Changes in vital signs, ECG, and laboratory tests

    Exploratory Endpoints:
    • Absolute change from baseline in fresh pustule count at Day 7, Day 14, and Day 21
    • Relative change from baseline in fresh pustule count at Day 7, Day 14, and Day 21
    • Absolute change from baseline in total pustule count at Day 7, Day 14, and Day 21
    • Relative change from baseline in total pustule count at Day 7, Day 14, and Day 21
    • Proportion of subjects achieving a 50% reduction in fresh pustule count at Day 7, Day 14, and Day 21
    • Proportion of subjects achieving a 75% reduction in fresh pustule count at Day 7, Day 14, Day 21, and Day 28
    • Proportion of subjects achieving a 50% reduction in total pustule count at Day 7, Day 14, and Day 21
    • Proportion of subjects achieving a 75% reduction in total pustule count at Day 7, Day 14, Day 21, and Day 28
    • Absolute change from baseline in PPPASI at Day 7, Day 14, Day 21, and Day 28
    • Relative change from baseline in PPPASI at Day 7, Day 14, Day 21, and Day 28
    • Proportion of subjects achieving a PPPASI-50 at Day 7, Day 14, Day 21, and Day 28
    • Proportion of subjects achieving a PPPASI-75 at Day 7, Day 14, Day 21, and Day 28
    • Absolute change from baseline in PPPGA at Day 7, Day 14, Day 21, and Day 28
    • Relative change from baseline in PPPGA at Day 7, Day 14, Day 21, and Day 28
    • Proportion of subjects achieving a PPPGA of clear (0) or almost clear (1) with a 2-point decrease at Day 7, Day 14, Day 21, and Day 28
    • Proportion of subjects achieving at least a 2-point decrease in PPPGA at Day 7, Day 14, Day 21, and Day 28
    • Absolute change from baseline in PPSI at Day 7, Day 14, Day 21, and Day 28
    • Proportion of subjects achieving a PPSI-50 at Day 7, Day 14, Day 21, and Day 28
    • Proportion of subjects achieving a PPSI-75 at Day 7, Day 14, Day 21, and Day 28
    • Relative change from baseline in PPSI at Day 7, Day 14, Day 21, and Day 28
    • Absolute change from baseline in pain VAS at Day 7, Day 14, Day 21, and Day 28
    • Relative change from baseline in pain VAS at Day 7, Day 14, Day 21, and Day 28
    • Absolute change from baseline in DLQI at Day 7, Day 14, Day 21, and Day 28
    • Relative change from baseline in DLQI at Day 7, Day 14, Day 21, and Day 28
    • Absolute change from baseline in BSA at Day 7, Day 14, Day 21, and Day 28
    • Relative change from baseline in BSA at Day 7, Day 14, Day 21, and Day 28
    • Absolute change from baseline in PASI at Day 7, Day 14, Day 21, and Day 28
    • Relative change from baseline in PASI at Day 7, Day 14, Day 21, and Day 28
    • Absolute change from baseline in PGA at Day 7, Day 14, Day 21, and Day 28
    • Relative change from baseline in PGA at Day 7, Day 14, Day 21, and Day 28
    E.5.2.1Timepoint(s) of evaluation of this end point
    EOT
    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 No
    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.7.1.3.1Other 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Germany
    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
    The end of the study is defined as completion of the last visit or procedure shown in the schedule of events for the last enrolled subject in the trial globally for all sites.
    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 months8
    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 months11
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 No
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 30
    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)
    none
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-04-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-11
    P. End of Trial
    P.End of Trial StatusOngoing
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