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    Summary
    EudraCT Number:2020-005431-70
    Sponsor's Protocol Code Number:CRN00808-09
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-08-04
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2020-005431-70
    A.3Full title of the trial
    A Randomized, Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Paltusotine in Subjects with Acromegaly Treated with Long-acting Somatostatin Receptor Ligands.
    Estudio multicéntrico, aleatorizado, para evaluar la seguridad y eficacia de paltusotina en pacientes con acromegalia tratados con análogos de la somatostatina de acción prolongada.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Evaluate the Safety and Efficacy of Paltusotine in Subjects with Acromegaly
    Estudio para evaluar la seguridad y eficacia de paltusotina en pacientes con acromegalia.
    A.3.2Name or abbreviated title of the trial where available
    PATHFNDR-1
    A.4.1Sponsor's protocol code numberCRN00808-09
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04837040
    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 SponsorCrinetics Pharmaceuticals, 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 supportCrinetics Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCrinetics Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointCrinetics Clinical Trials
    B.5.3 Address:
    B.5.3.1Street Address10222 Barnes Canyon Road, Bldg. 2
    B.5.3.2Town/ citySan Diego
    B.5.3.3Post codeCA 92121
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@crinetics.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.3.1Product namePaltusotine
    D.3.2Product code CRN00808
    D.3.4Pharmaceutical form Tablet
    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 INNPaltusotine
    D.3.9.1CAS number 2172870-89-0
    D.3.9.2Current sponsor codeCRN00808
    D.3.9.3Other descriptive namePaltusotine
    D.3.9.4EV Substance CodeSUB194845
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 placeboTablet
    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
    Acromegaly
    Acromegalia
    E.1.1.1Medical condition in easily understood language
    Acromegaly is typically caused by a growth hormone (GH) secreting tumor in the pituitary.
    La acromegalia suele estar causada por un tumor que segrega la hormona del crecimiento (GH) en la hipófisis.
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10000599
    E.1.2Term Acromegaly
    E.1.2System Organ Class 10014698 - Endocrine 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 evaluate the effect of paltusotine versus placebo on IGF 1 response
    Evaluar el efecto de la paltusotina frente al placebo en la respuesta del IGF-1.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of paltusotine versus placebo on IGF 1 level
    To evaluate the effect of paltusotine versus placebo on GH response
    To evaluate the effect of paltusotine versus placebo on acromegaly symptoms.
    Evaluar el efecto de la paltusotina frente al placebo en los niveles de IGF-1.
    Evaluar el efecto de la paltusotina frente al placebo en la respuesta de la GH.
    Evaluar el efecto de la paltusotina frente al placebo en los síntomas de la acromegalia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male and female subjects ≥18 years of age
    2.Confirmed diagnosis of acromegaly and controlled (as measured by IGF-1 ≤1.0×ULN) via stable dose of protocol defined somatostatin receptor ligand therapy.
    3.Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, or using effective method(s) of birth control.
    4-Willing to provide signed informed consent.
    1.Sujetos masculinos y femeninos ≥18 años de edad.
    2.Diagnóstico confirmado de acromegalia y controlada (medido por IGF-1 ≤1.0×LSN) mediante una dosis estable de terapia de ligando del receptor de somatostatina definida por el protocolo.
    3. Las mujeres no deben estar embarazadas ni en periodo de lactancia, y deben ser quirúrgicamente estériles, posmenopáusicas o utilizar métodos anticonceptivos eficaces.
    4.Estar dispuestas a proporcionar un consentimiento informado firmado.
    E.4Principal exclusion criteria
    1.Treatment naïve acromegaly subjects
    2.Prior treatment with paltusotine.
    3.History of pituitary radiation therapy.
    4.History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years
    5.Use of any investigational drug within the past 30 days or 5 half-lives, whichever is longer.
    6.Known history of HIV, hepatitis B, or active hepatitis C.
    7.History of alcohol or substance abuse in the past 12 months.
    8.Cardiovascular conditions or medications associated with prolonged QT or those which predispose subjects to heart rhythm abnormalities.
    9.Subjects with symptomatic cholelithiasis.
    10.Subjects with clinically significant abnormal findings during the Screening Period, or any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardize the subject's safety or ability to complete the study
    11.Subjects currently taking pasireotide LAR (within 24 weeks prior to Screening) or pegvisomant, dopamine agonists, or short acting somatostatin analogs (with 12 weeks prior to Screening)
    1.Sujetos con acromegalia sin tratamiento.
    2.Tratamiento previo con paltusotina.
    3.Antecedentes de radioterapia hipofisaria.
    4. Antecedentes o presencia de enfermedades malignas, excepto carcinomas de células basales y escamosas de la piel adecuadamente tratados en los últimos 5 años.
    5.Uso de cualquier medicamento en investigación en los últimos 30 días o 5 semi-vidas, lo que sea más largo.
    6.Antecedentes conocidos de VIH, hepatitis B o hepatitis C activa.
    7.Antecedentes de abuso de alcohol o sustancias en los últimos 12 meses.
    8.Afecciones cardiovasculares o medicamentos asociados con la prolongación del QT o que predispongan a los sujetos a sufrir anomalías del ritmo cardíaco.
    9.Sujetos con colelitiasis sintomática.
    10.Sujetos con hallazgos anormales clínicamente significativos durante el período de cribado, o cualquier otra condición médica o hallazgos de laboratorio que, en opinión del investigador, puedan poner en peligro la seguridad del sujeto o su capacidad para completar el estudio.
    11. Sujetos que estén tomando actualmente pasireotida de acción prolongada (dentro de las 24 semanas anteriores a la selección) o pegvisomant, agonistas de la dopamina o análogos de la somatostatina de acción corta (dentro de las 12 semanas anteriores a la selección)
    E.5 End points
    E.5.1Primary end point(s)
    •Proportion of subjects who maintain biochemical response in IGF 1 (≤1.0×the upper limit of normal [ULN]) at the End of the Randomized Control Phase (EOR)
    Proporción de pacientes que logran mantener una respuesta bioquímica basada en los niveles de IGF-1 (≤1,0×LSN) al final de la fase de randomización.
    E.5.1.1Timepoint(s) of evaluation of this end point
    36 weeks for the primary endpoint.
    36 semanas para el criterio de valoración principal.
    E.5.2Secondary end point(s)
    •Change from baseline in IGF-1, in units of ULN, to EOR
    •Proportion of subjects with GH <1.0 ng/mL at Week 34, out of those who had GH <1.0 ng/mL at Screening
    •Change from baseline in Total Acromegaly Symptoms Diary (ASD) score to EOR.
    - Variación en los niveles de IGF-1 respecto a los niveles iniciales, en unidades de LSN, en la visita FFA.
    - Proporción de pacientes con niveles de GH <1,0 ng/ml en la semana 34, entre los que presentaban niveles de GH <1,0 ng/ml en la selección.
    - Variación en la puntuación total del diario de síntomas de acromegalia (DSA), respecto a la puntuación inicial, en la visita FFA.
    E.5.2.1Timepoint(s) of evaluation of this end point
    36 weeks for the secondary endpoint.
    36 semanas para el criterio de valoración secundario.
    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 Yes
    E.6.10Pharmacogenetic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Brazil
    Israel
    Peru
    Russian Federation
    Serbia
    United States
    Austria
    Belgium
    Bulgaria
    France
    Germany
    Hungary
    Italy
    Poland
    Spain
    United Kingdom
    Argentina
    E.8.7Trial has a data monitoring committee Yes
    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
    Last visit of the last subject in the study
    Última visita del último paciente en el estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 42
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 19
    F.4.2.2In the whole clinical trial 52
    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)
    Extended treatment will be available to eligible subjects who complete the RC phase. They may enter the OLE and continue or initiate treatment with paltusotine until EOT: 96 weeks.
    El tratamiento prolongado estará disponible para los sujetos elegibles que completen la fase tratamiento. Podrán entrar en la OLE y continuar o iniciar el tratamiento con paltusotina hasta el fin de tratamiento: 96 semanas.
    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 Decision2021-08-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-29
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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