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    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2021-001703-32
    Sponsor's Protocol Code Number:CRN00808-08
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-03-10
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2021-001703-32
    A.3Full title of the trial
    A Randomized, Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Paltusotine in Subjects with Non-pharmacologically Treated Acromegaly
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study where subjects with non-pharmacologically treated acromegaly will be randomly allocated to receive either paltusotine or placebo.
    A.3.2Name or abbreviated title of the trial where available
    PATHFNDR-2
    A.4.1Sponsor's protocol code numberCRN00808-08
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05192382
    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 Address6055 Lusk Blvd
    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 (Free base)
    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
    E.1.1.1Medical condition in easily understood language
    Acromegaly is typically caused by a growth hormone (GH) secreting tumor in the pituitary.
    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
    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 IGF-1 response
    To evaluate the effect of paltusotine versus placebo on GH response
    To evaluate the effect of paltusotine versus placebo on acromegaly symptoms
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Willing and able to provide written informed consent prior to any study-related procedures.
    2. Willing and able to comply with the study procedures as specified in the protocol and comply with the study treatment administration.
    3. Subjects ≥18 years of age at the time of Screening, who fall into 1 of the following 3 groups are eligible to participate in the study.
    • Medically naïve group (Group 1): Those who have not been previously treated with acromegaly medications (including LA-SRLs) who at Screening have IGF 1 ≥1.3×ULN (the lower limit for eligibility is mean IGF-1 of 1.25×ULN when rounded to 2 decimal places) confirmed by the central laboratory test at S1. Group 1 subjects must have had at least 1 pituitary surgery 3
    months or more prior to Screening.
    • Previously Treated group (no treatment within previous 4 months) (Group 2): Subjects who have last been treated with acromegaly medications at least 4 months prior to Screening and who have IGF 1 ≥1.3×ULN (the lower limit for
    eligibility is mean IGF-1 of 1.25 when rounded to 2 decimal places) confirmed by the central laboratory test at S1.
    • Washout group (Group 3): Subjects at Screening who are receiving stable treatment (no change in dose for 3 months prior to Screening) with octreotide or lanreotide monotherapy, who have IGF-1 ≤1.0×ULN (the upper limit for eligibility is mean IGF-1 of 1.04 when rounded to 2 decimal places) at Screening Visit 1 and are willing to washout of their medication during the Screening Period. Any form of pretrial octreotide or lanreotide monotherapy (long- or short-acting [SC, IM, or oral]) can be washed out
    and will determine the duration of the Screening Period. After informed consent is provided, the subject should not receive further pretrial acromegaly medication. IGF-1 must rise at least 30% from the first Screening Visit to the last Screening Visit and to ≥1.1×ULN (the lower limit for eligibility is mean IGF-1 of 1.05 when rounded to 2 decimal places) confirmed by the central laboratory test at S2 or S3, if needed) to qualify for enrollment.
    4. Previous diagnosis of acromegaly confirmed by the Investigator and approved by the Medical Monitor. This requires evaluable documentation of a pituitary adenoma.
    5. If currently using thyroid hormone therapy, the subject should be adequately treated based on clinical status and free thyroxine concentration measured during Screening and on a stable dose of thyroid hormone for at least 8 weeks prior to Screening.
    6. Females who engage in heterosexual intercourse must be of non childbearing potential, defined as either surgically sterile (i.e., hysterectomy, bilateral salpingectomy, or bilateral oophorectomy), OR be postmenopausal with at least 1 year of amenorrhea, OR must agree to use either a highly effective or a clinically acceptable method of contraception from the beginning of Screening until at least 30 days after the last dose of study drug.
    7. If the subject is male, the subject should agree to use a condom when sexually active with a female partner of childbearing potential from Screening until at least 30 days after the last dose of study drug (or be surgically sterile [i.e., vasectomy with documentation]; or remain abstinent [when this is in line with the preferred and usual lifestyle]. Male subjects should also agree to not donate sperm for the duration of the study and until at least 30 days after the last dose of study drug.
    E.4Principal exclusion criteria
    1. History of ineffectiveness or significant intolerance of octreotide or lanreotide treatment, as determined by the Investigator.
    2. History of pituitary radiation therapy within 3 years of Screening.
    3. Subjects with adrenal insufficiency, diabetes insipidus, or central hypogonadism who are not receiving adequate hormone replacement therapy at the time of Screening, as determined by the Investigator.
    4. High risk pituitary tumor pattern as defined by:
    • Compression of the optic chiasm or invasion of adjacent brain structures (other than sphenoid sinus or cavernous sinus)
    • History of tumor growth within 1 year after surgery or radiation (unless it occurred during a period of medical therapy interruption)
    • Anticipated requirement for neurosurgical intervention or radiation therapy within the time course of the study.
    • Pituitary carcinoma currently or at any time in the past.
    5. History of major surgery/surgical therapy for any cause within 4 weeks prior to Screening.
    6. Diabetes mellitus treated with insulin for less than 6 weeks prior to the study entry, or with change in total daily insulin dose by >15% within 6 weeks prior to Screening.
    7. History of unstable angina or acute myocardial infarction within the 12 weeks preceding the Screening Visit or other clinically significant cardiac disease at the time of screening as judged by the Investigator.
    8. Known history of hepatitis B or human immunodeficiency virus, or active hepatitis C infection.
    9. Active malignant disease within the last 5 years with exception of basal and squamous cell carcinoma of the skin with complete local excision and resected carcinoma in situ of cervix.
    10. Concomitant mental condition rendering him/her unable to understand the nature, scope, and possible consequences of the study, and/or evidence of poor compliance with medical instructions.
    11. Use of the following medications as outlined:
    Any history of acromegaly medication use (G1 only)
    • Lanreotide depot or octreotide LAR (within 16 weeks before Screening) (G2 only)
    • Pasireotide LAR (within 24 weeks prior to Screening)
    • Pegvisomant (within 16 weeks before Screening)
    • Dopamine agonists (within 16 weeks before Screening)
    • Any combination of 2 or more acromegaly medications at Screening
    • Proton pump inhibitors (from start of Screening) until the end of the study
    12. Current use of oral estrogen replacement therapy for <12 weeks prior to Screening.
    13. Current use of medications that are strong inducers of CYP3A4 within 2 weeks prior to Screening
    14. Known allergy or hypersensitivity to any of the test materials or related compounds.
    15. Active COVID-19 confirmed or suspected based on clinical symptoms.
    16. Symptomatic cholelithiasis.
    17. Clinically significant concomitant disease including but not limited to cardiovascular disease, severe renal insufficiency (estimated glomerular filtration rate <30 mL/min/1.73 m2), or significant liver disease (including cirrhosis).
    18. 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.
    19. Systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg during Screening. If the initial measurement is out of range, it may be repeated 2 more times after 15 minutes and the last assessment should be used to determine subject’s eligibility.
    20. Resting (at least 10 minutes) palpated pulse rate <45 bpm or >105 bpm during Screening. If either of these criteria is met, the assessment should be repeated 2 more times and the last assessment should be used to determine the subject’s eligibility.
    21. QT interval corrected using Fridericia’s formula (QTcF) >480 msec (or corrected QT [QTc] interval >500 msec in the presence of complete bundle branch block) or PR interval >240 msec during Screening based on a central reading of an average of 3 ECGs each separated in time by approximately 1 minute after the subject has rested quietly in the supine position for at least 10 minutes without significant stimulation (noise, television, etc.).
    22. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >3×ULN, and/or total bilirubin >1.5×ULN during Screening. Subjects with previously diagnosed Gilbert’s syndrome not accompanied by other hepatobiliary disorders and associated with total bilirubin <3.5 mg/dL (<51.3 µmol/L) will be permitted.
    23. Poorly controlled diabetes mellitus defined as having a hemoglobin A1c (HbA1c) ≥8.5% (≥69 mmol/mol), or estimated HbA1c based on fructosamine if HbA1c is not evaluable (e.g., due to hemoglobinopathies).
    24. Female subjects who are pregnant or lactating. Subjects must have a negative pregnancy test during Screening and prior to the first dose of study drug.
    25. Known history of, or current alcohol or drug abuse, within the last year.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects who achieve biochemical response in IGF-1 (≤1.0× the upper limit of normal [ULN]) at the End of the Randomized Control Phase (EOR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks for the primary endpoint.
    E.5.2Secondary end point(s)
    Change from baseline in IGF-1, in units of ULN, to EOR

    Proportion of subjects who achieve IGF-1 <1.3×ULN at EOR
    Proportion of subjects with GH <1 ng/mL at Week 22
    Change from baseline in Total Acromegaly Symptoms Diary (ASD) score to EOR
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 weeks for the secondary endpoint.
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA31
    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
    Argentina
    Peru
    Brazil
    China
    India
    Israel
    United Kingdom
    United States
    Bulgaria
    France
    Germany
    Greece
    Hungary
    Italy
    Poland
    Spain
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    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: 84
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 37
    F.4.2.2In the whole clinical trial 98
    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)
    An End of Study (EOS) Visit will occur at Week 228 to collect final safety data and other assessments as detailed in the SOAs. The EOS is defined as the date of the last visit of the last subject in the study.

    Subjects who complete the 24-week RC phase or who meet rescue criteria and complete the 24 week RC phase with rescue medication can continue participation in the OLE phase.
    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 Decision2022-05-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-24
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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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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