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    Summary
    EudraCT Number:2021-006233-19
    Sponsor's Protocol Code Number:COMP401
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-05-10
    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 ConcernedIreland - HPRA
    A.2EudraCT number2021-006233-19
    A.3Full title of the trial
    Efficacy and safety of COMP360 psilocybin therapy in anorexia nervosa: a proof-of-concept study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of COMP360 psilocybin therapy in anorexia nervosa: a proof-of-concept study
    A.4.1Sponsor's protocol code numberCOMP401
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05481736
    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 SponsorCOMPASS Pathfinder Limited
    B.1.3.4CountryUnited Kingdom
    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 supportCOMPASS Pathfinder Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCOMPASS Pathfinder Limited
    B.5.2Functional name of contact pointMatthew Anderton
    B.5.3 Address:
    B.5.3.1Street Address3rd Floor, 1 Ashley Road
    B.5.3.2Town/ cityAltrincham, Cheshire
    B.5.3.3Post codeWA14 2DT
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailclinicaloperations@compasspathways.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 nameCOMP360
    D.3.4Pharmaceutical form Capsule
    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 INNPsilocybine
    D.3.9.1CAS number 520-52-5
    D.3.9.3Other descriptive namePsilocybin
    D.3.9.4EV Substance CodeSUB10158MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.IMP: 2
    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 nameCOMP360
    D.3.4Pharmaceutical form Capsule
    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 INNPsilocybine
    D.3.9.1CAS number 520-52-5
    D.3.9.3Other descriptive namePsilocybin
    D.3.9.4EV Substance CodeSUB10158MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 placeboCapsule
    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
    Anorexia Nervosa (AN)
    E.1.1.1Medical condition in easily understood language
    Anorexia Nervosa (AN)
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Objective
    -To assess the efficacy of COMP360 with psychological support in improving AN symptoms.
    E.2.2Secondary objectives of the trial
    Safety Objective
    - To assess the safety and tolerability of COMP360 delivered under supportive conditions.

    Secondary Objectives
    -To assess the effects of COMP360 on associated obsessive compulsive symptoms typical of AN.
    -To assess effects of COMP360 on weight gain in participants with AN.

    Please refer to protocol for the exploratory objectives.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed ICF.
    2. Any sex and aged 18 years or above at screening.
    3. Meeting criteria for AN either restrictive or binge-purging type, according to the DSM-5, based on medical records, clinical assessment, BMI, documented completion of MINI 7.0.2, and EDE at screening.
    4. Have successfully discontinued all prohibited medications for a period of at least two weeks prior to baseline. For fluoxetine (Prozac), immediate cessation at screening period visit 1a followed by at least four weeks of washout will be required prior to baseline.
    5. Has a history of disordered eating with duration of at least 3 years prior to screening, that is consistent with AN.
    6.BMI ≥15 kg/m2 and ≤20 kg/m2. For participants with a BMI <16 kg/m2 and >18.5 kg/m2 at screening, the approval from the Medical Monitor will be required. Any participant with a BMI >18.5 kg/m2 must meet all of criteria for AN except that, despite significant weight loss, the individual’s weight is within or above the normal range.
    7. Have a CGI-S score≥4, corresponding to at least moderately ill, at both screening and baseline.
    8. Being otherwise medically stable at screening determined by clinical interview, clinical laboratory values, vital signs, ECG, and medical history.
    9. Have at least one documented prior attempt at treatment in the past 3 years.
    10. Agree to have the study team maintain contact with an identified companion for the duration of the study.
    11. Able to complete all protocol required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits.
    E.4Principal exclusion criteria
    Exclusion of potentially confounding psychiatric diseases and therapies:
    1. Prior or ongoing bipolar disorder, any psychotic disorder, including schizophrenia, schizophreniform disorder, schizoaffective disorder, brief psychotic disorder, antisocial personality disorder, or any serious psychiatric comorbidity as assessed by medical history and a structured clinical interview (MINI 7.0.2).
    2. Prior or ongoing paranoid, schizoid, schizotypal, histrionic, narcissistic personality disorder based on medical history and clinical judgment.
    3. Prior psychotic episode (including substance induced or due to a medical condition) as documented in medical history, reported by the participant, or determined according to clinical judgment.
    4. Family history of psychosis in a biological first-degree relative, as reported by the participant
    5. Borderline personality disorder as demonstrated by medical history, the MINI Plus — BPD and clinical judgment.
    6. Significant suicide risk as defined by (1) suicidal ideation as endorsed on items 4 or 5 on the C-SSRS within the past year, at screening or at baseline, or; (2) suicidal behaviours within the past year or; (3) clinical assessment of significant suicidal risk during participant interview.
    7. Current (within last year) alcohol or substance use disorder as informed by the DSM-5 assessed via the MINI 7.0.2, and urine toxicology at screening.
    8. Other personal circumstances and behaviour judged to be incompatible with establishment of rapport or safe exposure to psilocybin.
    9. Exposure to psilocybin, or any other psychedelics, such as ayahuasca, mescaline, LSD, or peyote within the past year.

    General medical exclusion criteria:
    1. A participant reported average weight loss (>1 kg per week) in the 4 weeks prior to screening.
    2. Significant weight loss (>1 kg per week) measured between screening and baseline.
    3. Clinically significant abnormal findings, on the physical examination at screening and baseline.
    4. A participant who is pregnant, nursing, or planning to conceive. Males and females who engage in sexual intercourse which could result in pregnancy, must agree to use a highly effective contraceptive method (as listed in Protocol Section 10.1.2) throughout their participation in the study. Participants of childbearing potential must have a negative serum pregnancy test at screening, and negative urine pregnancy test at baseline. Participants should be informed not to donate sperm during the study period or for at least three months after COMP360 administration.
    5. Clinically significant laboratory test abnormalities at screening including full blood count (hemoglobin <10 g/dL), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 × upper limit of normal (ULN), total bilirubin ≥ 1.5 × ULN or alkaline phosphatase ≥ 2.5 × ULN, reduced glomerular filtration rate (GFR< 60) or creatinine > 1.5 × ULN.
    6. Abnormal serum potassium levels (<3.6 mmol/L) at screening to exclude risk of hypokalaemia.
    7. Gilbert’s syndrome.
    8. Cardiovascular conditions: recent stroke (<1 year prior to signing ICF), recent myocardial infarction (<1 year prior to signing ICF), uncontrolled hypertension (blood pressure >140/90 mmHg), bradycardia (<50 beats per minute [bpm]), elongated corrected QT interval by Fredericia (QTcF; >450 ms for men and >470 ms for women), clinically significant arrhythmia (<1 year prior to signing the ICF) based on vital signs and ECG measurement at screening and baseline and medical history.
    9. Diabetes type 1 or uncontrolled diabetes type 2.
    10. Epilepsy or history of seizures.
    11. Positive urine drug screen for illicit drugs or drugs of abuse at screening and/or baseline. Any positive urine drug test will be reviewed with participants to determine the pattern of use and eligibility will be determined at the investigator’s discretion in conjunction with the medical monitor.
    12. Current enrolment in any investigational drug or device study or participation in such within 30 days of screening.
    13. Any other clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal or any other major concurrent illness that, in the opinion of the investigator, may interfere with the interpretation of the study results or constitute a health risk for the participant if he/she takes part in the study.
    14. Hypersensitivity to the investigational medicinal product (IMP) or any of the excipients.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in the EDE global score at week 4 (COMP360 25 mg vs 1 mg).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Change from baseline in the EDE global score at week 4 (COMP360 25 mg vs 1 mg).
    E.5.2Secondary end point(s)
    To assess COMP360 25 mg versus 1 mg for the following:

    - Change from baseline in Y-BOCS at week 4.
    - Change from baseline in weight at week 12.

    Safety, as assessed by:

    - Adverse events (AEs)
    - ECG
    - Blood pressure and pulse variability during dosing session
    - Vital signs (including orthostatic vital signs)
    - Clinical laboratory tests
    - Suicidality assessed via the C-SSRS
    - BPRS+
    - mDESS

    Please refer to the protocol for exploratory endpoints.
    E.5.2.1Timepoint(s) of evaluation of this end point
    To assess COMP360 25 mg versus 1 mg for the following:

    - Change from baseline in Y-BOCS at week 4.
    - Change from baseline in weight at week 12.

    Change in safety endpoints throughout the course of the study.
    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 No
    E.6.7Pharmacodynamic No
    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 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 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
    United Kingdom
    United States
    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
    LVLS
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 48
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 15
    F.4.2.2In the whole clinical trial 60
    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)
    Standard care
    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 Decision2023-01-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-14
    P. End of Trial
    P.End of Trial StatusOngoing
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