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    Summary
    EudraCT Number:2020-000659-11
    Sponsor's Protocol Code Number:GLPG3970-CL-210
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-07-23
    Trial results View 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 number2020-000659-11
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety, tolerability, efficacy, and pharmacokinetics of GLPG3970, administered orally for 6 weeks in adult subjects 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 study evaluating the effects of GLPG3970 given as an oral treatment for 6 weeks in adults with ulcerative colitis
    A.4.1Sponsor's protocol code numberGLPG3970-CL-210
    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 SponsorGalapagos NV
    B.1.3.4CountryBelgium
    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 supportGalapagos NV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGalapagos NV
    B.5.2Functional name of contact pointClinical trial information desk
    B.5.3 Address:
    B.5.3.1Street AddressGeneraal De Wittelaan L11 A3
    B.5.3.2Town/ cityMechelen
    B.5.3.3Post code2800
    B.5.3.4CountryBelgium
    B.5.4Telephone number+3215342 900
    B.5.5Fax number+3215342 901
    B.5.6E-mailrd@glpg.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 nameGLPG3970
    D.3.2Product code G1567970
    D.3.4Pharmaceutical form Powder and solvent for 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 INNNot applicable
    D.3.9.2Current sponsor codeG1567970
    D.3.9.3Other descriptive nameGLPG3970
    D.3.9.4EV Substance CodeSUB198844
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 placeboPowder and solvent for oral 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
    Ulcerative Colitis
    E.1.1.1Medical condition in easily understood language
    Inflammatory Bowel Diseases
    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 100000004856
    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 effect of GLPG3970 compared to placebo on the signs and symptoms of Ulcerative Colitis (UC) in subjects with moderately to severely active UC.
    E.2.2Secondary objectives of the trial
    - To evaluate the safety and tolerability of GLPG3970 compared to placebo in subjects with moderately to severely active UC.
    - To characterize the pharmacokinetics (PK) of GLPG3970 in subjects with moderately to severely active UC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject must be able and willing to comply with the clinical study protocol requirements and must sign and date the informed consent form (ICF) as approved by the Independent Ethics Committee (IEC) / Institutional Review Board (IRB), prior to any screening evaluations.
    2. Subjects must be ≥18 and <65 years of age, on the date of signing the ICF.
    3. Documented diagnosis of UC of ≥3 months. The criteria for documentation of UC diagnosis based on endoscopy will be medical record documentation, and/or a colonoscopy report dated ≥3 months before screening, which shows features consistent with UC.
    4. Treatment-experienced subjects with moderately to severely active disease, who have either previously demonstrated inadequate clinical response, loss of response, or intolerance to at least 1 course of standard-of-care (SoC) therapy for UC (i.e. steroids [oral or parenteral,
    including but not limited to prednisone, prednisolone, budesonide], 5-aminosalicylate [5- ASA] derivatives [including but not limited to mesalamine, sulfasalazine], anti-metabolites [including but not limited to azathioprine, 6 mercaptopurine, methotrexate], anti-TNF
    agents, anti-integrins, Janus kinase [JAK] inhibitors), as confirmed by the investigator.
    5. Moderately to severely active UC as determined at screening by:
    a. Centrally-read endoscopic evidence of disease activity (MCS-ES ≥2 OR UCEIS ≥4) with a minimum disease extent of 15 cm from anal verge; AND
    b. MCS SF subscore ≥1; AND
    c. MCS RB subscore ≥1.
    6. Subjects currently receiving the following SoC therapies for UC are eligible providing they have been on a stable dose for the designated period of time and are anticipated to be stable throughout the study:
    a. oral corticosteroids (prednisone ≤20 mg/day or equivalent or budesonide ≤3 mg/day) stable dose for at least 2 weeks prior to first IP dosing.
    b. oral 5-ASA compounds (mesalamine ≤4 g/day or sulfasalazine ≤4 g/day) stable dose for at least 4 weeks prior to first IP dosing.
    c. oral thiopurines (azathioprine ≤2.5 mg/kg/day and 6-mercaptopurine 1.5 mg/kg/day) stable dose for at least 12 weeks prior to first IP dosing, or methotrexate ≤20 mg/week, stable dose for at least 12 weeks prior to first investigational product (IP) dosing.

    This list only contains the key inclusion criteria.
    E.4Principal exclusion criteria
    1. Diagnosis of Crohn’s disease, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic megacolon.
    2. Prior surgical intervention for UC (e.g. colectomy, partial colectomy, ileostomy or colostomy) or likely requirement for surgery for UC, during the study.
    3. History or evidence of incompletely resected colonic mucosal dysplasia.
    4. Exhibit acute severe UC per the following criteria:
    a. bloody diarrhea ≥6/day AND
    b. any of the following signs of systemic toxicity:
    Body temperature (oral or tympanic) ≥37.8°C OR
    Resting pulse (after 5 min seated position) >90 beats per min OR
    hemoglobin <105 g/L, OR
    erythrocyte sedimentation rate >30 mm/h; OR
    C-reactive protein (CRP) >30 mg/L.
    5. Screening stool sample positive for ova and/or parasites, Clostridium difficile toxin, Escherichia coli, Salmonella species (spp), Shigella spp, Campylobacer spp or Yersinia spp.
    6. Subject testing positive at screening for SARS-CoV-2 infection as detected by real time polymerase chain reaction (RT-PCR), subjects presenting any signs or symptoms as detected at baseline following careful physical examination (e.g. cough, fever, headaches, fatigue, dyspnea, myalgia, anosmia, dysgeusia, anorexia, sore throat, others) or reporting any signs and symptoms for the preceding 2 weeks, or subjects who have been exposed to individuals with confirmed or suspected diagnosis of SARS-CoV-2 within 2 weeks prior to baseline. In addition, any other locally applicable standard diagnostic criteria may also apply to rule out SARS-CoV-2 infection.

    This list only contains the key exclusion criteria.
    E.5 End points
    E.5.1Primary end point(s)
    - Change from baseline in total Mayo Clinical Score (MCS) at Week 6.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At baseline and at Week 6
    E.5.2Secondary end point(s)
    - Number, incidence, and severity of treatment-emergent adverse events.
    - Observed GLPG3970 plasma trough concentrations (Ctrough).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Various timepoints during the trial as per clinical study design.
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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 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 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
    Georgia
    Moldova, Republic of
    Ukraine
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months7
    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: 30
    F.1.3Elderly (>=65 years) No
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 7
    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)
    After the subject has completed the study, the subject will receive a financial compensation, or depending on the country, the study physician may offer the option of a course of post-study medication approved for the treatment of ulcerative colitis at no cost and for a duration of up to 6 months.
    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 Decision2020-09-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-08-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-05-31
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