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    Summary
    EudraCT Number:2021-005288-31
    Sponsor's Protocol Code Number:MORF-057-201
    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:2022-05-19
    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 number2021-005288-31
    A.3Full title of the trial
    A Phase 2a, Open-label, Single-arm Study to Evaluate the Efficacy, Safety, and Tolerability of MORF-057 in Adults with Moderately to Severely Active Ulcerative Colitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2a study to evaluate the Efficacy, Safety, and Tolerability of MORF-057 in Ulcerative Colitis
    A.4.1Sponsor's protocol code numberMORF-057-201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05291689
    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 SponsorMorphic Therapeutic, 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 supportMorphic Therapeutic, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMorphic Therapeutic, Inc.
    B.5.2Functional name of contact pointDirector of Clinical Development
    B.5.3 Address:
    B.5.3.1Street Address35 Gatehouse Drive, A2
    B.5.3.2Town/ cityWaltham
    B.5.3.3Post codeMA 02451
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1617-816-1464
    B.5.6E-mailmichael.choi@morphictx.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 nameMORF-057
    D.3.2Product code MORF-057
    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 INNMORF-057
    D.3.9.3Other descriptive nameMORF-057
    D.3.9.4EV Substance CodeSUB269330
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to Severe Ulcerative Colitis
    E.1.1.1Medical condition in easily understood language
    Ulcerative Colitis
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effects of MORF-057 on histologic improvement at Week 12
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of MORF-057
    To evaluate the effect of MORF-057 on clinical improvement at Week 12
    To characterize the PK of MORF-057
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 18 to 85 years of age, inclusive, at the time of signing the Informed Consent Form (ICF).
    2. Participant has had signs/symptoms of moderately to severely active UC for at least 3 months prior to
    Screening, and the diagnosis was confirmed during the Screening Period with the
    following criteria: a Modified MCS of 5 to 9 (inclusive) with an MES ≥2 (confirmed by
    central reader).
    3. Has an RHI Score of 10 or greater
    4. Has evidence of UC extending at least 15 cm from the anal verge
    5. Is an AT-naïve participant or a participant who had an inadequate response, loss of response, or intolerance to no more than 3 drugs in 2 classes of the following:
    a. TNF-α antagonists, including infliximab, adalimumab, or golimumab
    b. Interleukin (IL)-12/IL-23 antagonists, including ustekinumab
    c. JAK antagonists, including tofacitinib and upadacitinib
    d. S1P receptor agonists, including ozanimod
    e. Any investigational product with the same mechanism as one of those outlined
    above (5a through 5d)
    f. Integrin inhibitors, including vedolizumab (participants in the Exploratory Cohort
    only)
    6. Meets the following wash out criteria of prior UC therapy relative to study Day 1:
    a. TNF-α antagonists: at least 8 weeks
    b. IL-12/IL-23 antagonists, including ustekinumab: at least 8 weeks
    c. JAK antagonists, including tofacitinib and upadacitinib: at least 2 weeks
    d. S1P receptor agonists, including ozanimod: at least 4 weeks
    7. If the participant has been receiving any of the non-prohibited medications for UC listed below, he/she must discontinue use at least 5 half-lives before study Day 1 or must agree to maintain stable doses of these concomitant medications starting from the time specified below until the end of the Safety Follow-up Period, with the exception of tapering oral corticosteroid dose after 12 weeks of being in the trial.
    a. 5-Aminosalicylates (not exceeding 4.8 g per day): at least 2 weeks prior to studyDay 1
    b. Oral corticosteroids (not exceeding prednisone 30 mg per day, budesonide 9 mg per day, or equivalent): at least 2 weeks prior to study Day 1
    c. 6-Mercaptopurine (any stable dose): at least 4 weeks prior to study Day 1
    d. Azathioprine (any stable dose): at least 4 weeks prior to study Day 1
    e. Methotrexate (any stable dose): for at least 4 weeks prior to study Day 1
    8. In the opinion of the Investigator, the patient can fully participate in all aspects of this
    clinical study
    9. Has a body mass index (BMI) within the range of 18.0 and 40.0 kg/m2 (inclusive) at Screening
    10. A participant is eligible to participate if he/she agrees to abide by the guidelines set forth in this protocol regarding contraception requirements
    11. For the study Treatment Period and at least 28 days after receiving the last dose of MORF-057, male participants must agree not to donate sperm and female participants must agree not to donate eggs (ova, oocytes).
    12. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol

    Exploratory Cohort Inclusion Criteria:
    In addition to meeting Inclusion Criteria 1 through 12, the following criteria must be met for participants to be included in the Exploratory Cohort:
    13. Those intolerant to (e.g. infusion-related skin reaction, allergy, or side effects unrelated to α4β7 inhibition) or secondary non-responders to vedolizumab who have been dosed within the past 5 years with the drug. Up to 5 of the 10 Exploratory Cohort participants may be included based on clinical criteria only. The remaining participants must also meet at least 1 of the following criteria:
    a. Documented vedolizumab levels in blood of ≤10 µg/mL 6 to 8 weeks after their most recent dose or at what is considered clinical trough. If the participant has had vedolizumab levels in blood tested and documented in their medical chart prior to Screening, the test does not need to be repeated.
    b. Non-saturating receptor occupancy of vedolizumab in blood 6 to 8 weeks after their most recent dose
    c. Documented presence of anti-drug antibodies against vedolizumab. If the participant has had a positive anti-drug antibody test that has been documented prior to Screening, the test does not need to be repeated.
    *Note: Secondary non-response is defined as having initially responded to Induction therapy and then had recurrence of symptoms after receiving at least 2 of the Maintenance doses, 300 mg every 8 weeks (discontinuation despite clinical benefit does not qualify).
    14. The participants should also have received their last dose of vedolizumab at least 6 weeks prior to study Day 1 to allow sufficient washout
    E.4Principal exclusion criteria
    1. Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or CD or has clinical findings suggestive of CD.
    2. Has current evidence of un-resected colonic dysplasia or un-resected adenomatous colonic polyps or evidence of toxic megacolon, abdominal abscess, symptomatic colonic stricture, fistula, stoma, ileostomy, or colostomy at Screening.
    3. Currently requires or is anticipated to require surgical intervention for UC during the study or is planning to undergo major surgery during the study period.
    4. Has had a surgical procedure requiring general anesthesia within 30 days prior to Screening.
    5. Has a history of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, demyelinating, or neurodegenerative disease. For questions about whether this applies to a specific case, consult with the Medical Monitor.
    6. Has positive findings on a subjective neurological screening questionnaire or progressive multifocal leukoencephalopathy (PML) subjective symptom checklist during Screening or prior to the administration of the first dose of study drug on study Day 1
    7. Has an active bacterial, viral or parasitic pathogenic enteric infection, including Clostridium difficile; has cytomegalovirus, hepatitis B or C virus, or human immunodeficiency virus (HIV); had an infection requiring hospitalization or intravenous antimicrobial therapy,
    or an opportunistic infection within 3 months prior to Screening; had any infection requiring oral antimicrobial therapy within 2 weeks prior to Screening; or has a history of more than 1 episode of herpes zoster or any episode of disseminated herpes zoster infection
    8. Has a positive diagnostic tuberculosis (TB) test at Screening (defined as a positive QuantiFERON test). If the participant has had a confirmed negative QuantiFERON or other Interferon Gamma Release Assay test within 90 days prior to Screening, the test does not need to be repeated. In cases where the QuantiFERON test result is indeterminate, the participant may have the test repeated once, and if the second test is negative, the participant will be eligible. In the event the second test also has an indeterminate result or QuantiFERON is unavailable, the Investigator has the option to perform a purified protein derivative (PPD) skin test. If the PPD reaction is <5 mm, then the participant is eligible. If the reaction is ≥5 mm or PPD testing is not done, the participant is not eligible. An exception can be made for participants with a history of latent TB who are currently receiving treatment for latent TB per local standard care, who will initiate treatment for latent TB before the first dose of study drug, or who have documentation of completing appropriate treatment for latent TB within 2 years prior to study Day 1.
    9. Tests positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) during the Screening Period. Participants who test positive for SARS-CoV-2 can undergo retesting throughout the Screening Period. Testing to be performed according to site-specific testing procedures and country-specific requirements.
    10. Had any vaccination (including live virus vaccinations) within 3 weeks prior to study Day 1.
    11. Has a concurrent, clinically significant, serious, unstable comorbidity (such as uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder) that, in the judgement of the Investigator, would compromise compliance with the protocol, interfere with interpretation of the study results, or pre-dispose participants to safety risks.
    12. Has a known primary or secondary immunodeficiency.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline to Week 12 in the Robarts Histopathology Index (RHI) Score
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 0, Week 12
    E.5.2Secondary end point(s)
    - Frequencies and proportions for treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), and TEAEs leading to study drug discontinuation
    - Change from baseline to Week 12 in the Modified Mayo Clinic Score (MCS)
    - MORF-057 concentration in plasma
    - Plasma PK parameters
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Frequencies and proportions for treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), and TEAEs leading to study drug discontinuation
    between administration of the first dose of study drug and 7 days after the last dose of study drug

    - Change from baseline to Week 12 in the Modified Mayo Clinic Score (MCS)
    Week 0, Week 12

    - MORF-057 concentration in plasma
    Week 0 - Week 52

    - Plasma PK parameters
    Week 0 - Week 52
    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 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.8.3 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 concerned15
    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 States
    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
    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 days1
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days8
    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: 26
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 35
    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)
    Possibility to enroll into the Extension study.
    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 Decision2022-07-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-05-23
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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