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    EudraCT Number:2018-003831-31
    Sponsor's Protocol Code Number:MS1819/18/02
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-12-02
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2018-003831-31
    A.3Full title of the trial
    A multicenter, open-label Phase 2 study with escalating doses of MS1819-SD on top of a stable dose of PPEs, to investigate the efficacy and safety of this combination for the compensation of severe exocrine pancreatic insufficiency in CF patients not fully compensated with only PPEs
    Estudio Fase 2, multicéntrico y abierto de dosis ascendentes de MS1819-SD añadido a dosis estables de enzimas pancreáticas porcinas para investigar la eficacia y la seguridad de dicha combinación en la compensación de la insuficiencia pancreática exocrina grave en pacientes con fibrosis quística que no están totalmente cubiertos únicamente con enzimas pancreáticas porcinas.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MS1819-SD phase II clinical trial for Exocrine Pancreatic Insufficiency caused by Cystic Fibrosis.
    Ensayo clínico fase II de MS1819-SD para insuficiencia pancreática exocrina causada por fibrosis quística
    A.4.1Sponsor's protocol code numberMS1819/18/02
    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 SponsorAzurRx
    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 supportAzurRx
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzurRx
    B.5.2Functional name of contact pointR&D Program Director
    B.5.3 Address:
    B.5.3.1Street AddressJardin des Entreprises - 290, Chemin de St-Dionisy
    B.5.3.2Town/ cityLanglade
    B.5.3.3Post code30980
    B.5.4Telephone number+34961244000
    B.5.5Fax number+33(0)466 67 41 77
    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 nameMS1819-SD
    D.3.4Pharmaceutical form Capsule, hard
    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 INNLipase Lip2 from Yarrowia lipolytica
    D.3.9.3Other descriptive nameLIPASE LIP2
    D.3.9.4EV Substance CodeSUB130343
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number700 to 2240
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 Yes
    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
    Exocrine Pancreatic Insufficiency
    Insuficiencia pancreática exocrina
    E.1.1.1Medical condition in easily understood language
    Exocrine Pancreatic Insufficiency
    Insuficiencia pancreática exocrina
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10033628
    E.1.2Term Pancreatic insufficiency
    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
    Primary efficacy objective: To determine the efficacy of escalating doses of MS1819-SD on top of a stable dose of Porcine Pancreatic Extracts (PPEs) on triglyceride digestion assessed by coefficient of fat absorption (CFA) in patients with severe Exocrine Pancreatic Insufficiency (EPI) caused by cystic fibrosis (CF) and not fully compensated with only PPEs.
    Primary safety objective: To assess the safety and tolerability of escalating doses of MS1819-SD on top of a stable dose of PPEs in patients with severe EPI caused by CF.
    Objetivo de eficacia principal: Determinar la eficacia de los incrementos de dosis de MS1819-SD además de una dosis estable de extractos pancreáticos porcinos (PPE) sobre la digestión de los triglicéridos evaluada mediante el coeficiente de absorción grasa (CFA) en pacientes con insuficiencia pancreática exocrina (IPE) grave causada por fibrosis quística (FQ) y no compensada por completo únicamente con PPE.
    Objetivo de seguridad principal: Evaluar la seguridad y tolerabilidad de los incrementos de dosis de MS1819-SD además de una dosis estable de PPE en
    pacientes con IPE grave causada por FQ.
    E.2.2Secondary objectives of the trial
    Not Applicable
    No procede
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed and dated informed consent form.
    2. Age > or = 12 years at the time of screening
    3. Male or female.
    4. Under stable dose of PPE ≥ 1 month. Stable dose is defined as dose of medication not changed during this time period and the medication must be commercially available and be administered in the recommended dose range.
    5. A nutritional status as defined by:
    a. BMI < or = 22.0 kg/m2 for female patients
    b. BMI < or = 23.0 kg/m2 for male patients
    c. BMI < or = 50th percentile for patients 12 to < 18 years of age.
    6. Cystic fibrosis (CF), based on at least 2 clinical features consistent with CF in the opinion of the investigator and a sweat chloride concentration > 60 mmol/L by pilocarpine iontophoresis.
    7. Fecal pancreatic elastase-1 < 100 µg/g of stools at screening.
    8. Baseline CFA < 80% with a maximum daily dose of 10,000 lipase units/kg/day.
    9. Clinically stable with no documented evidence of significant respiratory symptoms that would require administration of intravenous antibiotics, oxygen supplementation, or hospitalization within the 30 days of screening.
    10. Male and female patients, if of childbearing potential, must use a reliable method of contraception during the study. A reliable method of birth control is defined as one of the following: oral or injectable contraceptives, intrauterine device, contraceptive implants, tubal ligation, hysterectomy, or a double-barrier method (diaphragm with spermicidal foam or jelly, or a condom), abstinence or vasectomy. Periodic abstinence (calendar, symptom-thermal, or post-ovulation methods) is not an acceptable method of contraception. The preferred and usual lifestyle of the patient must also be evaluated in determining if sexual abstinence is a reliable method of birth control.
    11. Be considered as reliable and capable of adhering to the protocol, according to the judgment of the investigator.
    1. Formulario de consentimiento informado firmado y fechado.
    2. Edad > o = 12 años en el momento de la selección.
    3. Sexo masculino o femenino.
    4. Con una dosis estable de PPE > o = 1 mes. La dosis estable se define como la dosis de medicación no modificada durante este periodo de tiempo y la medicación debe estar disponible comercialmente y administrarse en el intervalo de dosis recomendado.
    5. Un estado nutricional que se define por:
    a. IMC < o = 22,0 kg/m2 para pacientes femeninos
    b. IMC < o = 23,0 kg/m2 para pacientes masculinos
    c. IMC < o = percentil 50 para pacientes de 12 a < 18 años.
    6. Fibrosis quística (FQ), basada en al menos 2 síntomas clínicos compatibles con FQ en opinión del investigador Y concentración de cloruro en sudor > 60 mmol/l mediante iontoforesis de pilocarpina.
    7. Elastasa pancreática fecal-1 < 100 µg/g de heces en la selección.
    8. CFA inicial < 80 % con una dosis diaria máxima de 10 000 unidades de lipasa/kg/día
    9. Clínicamente estable sin prueba documentada de síntomas respiratorios significativos que requieran la administración de antibióticos intravenosos, oxigenoterapia u hospitalización en los 30 días previos a la selección.
    10. Los pacientes masculinos y femeninos, si están en edad fértil, deben usar un método anticonceptivo fiable durante el estudio. Un método anticonceptivo fiable se define como uno de los siguientes: anticonceptivos orales o inyectables, dispositivos intrauterinos, implantes anticonceptivos, ligadura de trompas, histerectomía o un método de doble barrera (diafragma con crema o gel espermicida, o un preservativo), abstinencia o vasectomía. La abstinencia periódica (métodos de calendario, sintotérmico o postovulación) no es un método anticonceptivo aceptable. También se debe evaluar el estilo de vida preferido y habitual del paciente para determinar si la abstinencia sexual es un método anticonceptivo fiable.
    11. Se considerará fiable y capaz de cumplir el protocolo según el criterio del investigador.
    E.4Principal exclusion criteria
    1. Established or suspected fibrosing colonopathy.
    2. Total or partial gastrectomy.
    3. A history of solid organ transplant or significant surgical resection of the bowel; significant resection of the bowel is defined as any resection of the terminal ileum or ileocecal valve. Patients who have had qualitative, long-term changes in nutritional status after any other bowel resection (eg, increased of new need for pancreatic enzyme supplementation compared with preoperative status to maintain the same nutritional status) should also be excluded.
    4. Any chronic diarrheal illness unrelated to pancreatic insufficiency (eg, infectious gastroenteritis, sprue, inflammatory bowel disease)
    5. Known hypersensitivity or other severe reaction to any ingredient of the investigational medicinal product (IMP).
    6. Bilirubin > 1.5 times upper limit normal (ULN).
    7. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times ULN.
    8. Alkaline phosphatase (ALP) > 5 times ULN.
    9. Gamma glutamyltransferase (GGT) > 5 times ULN.
    10. Signs and/or symptoms of liver cirrhosis or portal hypertension (eg, splenomegaly, ascites, esophageal varices), or documented liver disease unrelated to CF
    11. Known allergy to the stool marker.
    12. Feeding via an enteral tube during 6 months before screening
    13. Routine use of anti-diarrheals, anti-spasmodics, or cathartic laxatives, or a change in chronic osmotic laxatives (eg, polyethylene glycol) regimen in the previous laxative therapy within the last 12 months before screening
    14. History of severe constipation with < 1 evacuation/week under appropriate laxative therapy within the last 12 months before screening.
    15. Documentation of distal intestinal pseudo-obstruction syndrome within the last 12 months before screening.
    16. Forced Expiratory Volume < or = 30% at the screening visit.
    17. Lactation or known pregnancy or positive pregnancy test at both screening and baseline for women of childbearing potential.
    18. Participation in another clinical study involving an IMP within 30 days before inclusion or concomitantly with this study.
    19. Poorly controlled diabetes according the investigator’s judgement.
    1. Colonopatia fibrosante establecida o sospechosa.
    2. Gastrectomía total o parcial.
    3. Antecedentes de trasplante de órganos sólidos o resección quirúrgica significativa del intestino; la resección significativa del intestino se define como cualquier resección del ileon terminal o la válvula ileocecal. También se debe excluir a los pacientes que hayan tenido cambios cualitativos a largo plazo en el estado nutricional después de cualquier otra resección intestinal (p. ej., aumento de nueva necesidad de suplemento de enzima pancreática en comparación con el estado preoperatorio para mantener el mismo estado nutricional).
    4. Cualquier enfermedad diarreica crónica no relacionada con la insuficiencia pancreática (p. ej., gastroenteritis infecciosa, esprue, enfermedad intestinal inflamatoria).
    5. Hipersensibilidad diagnosticada u otra reacción grave a cualquier ingrediente del producto en investigación (PEI).
    6. Bilirrubina > 1,5 veces el límite superior normal (LSN).
    7. Alanina aminotransferasa (ALT) o aspartato aminotransferasa (AST) > 5 veces el LSN.
    8. Fosfatasa alcalina (ALP) > 5 veces el LSN.
    9. Gamma glutamil transferasa (GGT) > 5 veces el LSN.
    10. Señales o síntomas de cirrosis hepática o hipertensión portal (p. ej., esplenomegalia, ascitis, varices esofágicas), o enfermedad hepática diagnosticada no relacionada con la FQ.
    11. Alergia diagnosticada al marcador de heces.
    12. Alimentación enteral durante 6 meses antes de la selección.
    13. Administración rutinaria de antidiarreicos, antiespasmódicos o laxantes catárticos, o cambio en la posología de laxantes osmóticos crónicos (p. ej., polietilenglicol) en la terapia laxante previa en los últimos 12 meses antes de la selección.
    14. Antecedentes de estreñimiento grave con < 1 evacuación/semana bajo la terapia laxante adecuada en los últimos 12 meses antes de la selección.
    15. Documentación de síndrome de seudoobstrucción intestinal distal en los últimos 12 meses antes de la selección.
    16. Volumen espiratorio forzado < o = 30 % en la visita de selección.
    17. Lactancia o embarazo diagnosticado o positivo en prueba de embarazo tanto en la selección como en la evaluación inicial para mujeres en edad fértil.
    18. Participación en otro estudio clínico que implique un PEI en los últimos
    30 días antes de la inclusión o de manera concomitante con este estudio.
    19. Diabetes con un control deficiente según el criterio del investigador.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint:
    • Change in CFA from baseline (V2) to visits of phase C (V4, V5 and V6).

    Primary Safety Endpoints:
    Safety data, including all observed AEs with a particular focus on immunoallergic events and digestive symptomatology.
    Criterio de valoración de eficacia principal:
    • Cambio del CFA de la evaluación inicial (V2) en las visitas V4, V5 y V6 de la Fase C

    Criterios de valoración de seguridad principales:
    • Datos de seguridad, que incluyen todos los AA observados centrándose en particular en acontecimientos inmunoalérgicos y sintomatología digestiva.
    E.5.1.1Timepoint(s) of evaluation of this end point
    V4 - V5 and V6
    V4 - V5 y V6
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints:
    Key secondary endpoints:
    • Change from Phase B in the mean number of daily evacuations during the days of the stool collection period in each cycle in Phase C.
    • Change from Phase B in the mean consistency of stools assessed by the Bristol scale during the stool collection period in each cycle in Phase C.

    Secondary Safety Endpoints
    In addition to primary safety endpoints, laboratory test results will be summarized:
    • Fasting glucose.
    • Urinalysis
    • Hematology: Hematocrit, Hemoglobin, Erythrocyte count (RBC), Leukocytes (WBC), Absolute counts of: Neutrophils (segmented), Neutrophils juvenile (bands), Lymphocytes, Monocytes, Eosinophils, Basophils and Platelets.
    • Biochemistry: Serum concentration of: Sodium, Potassium, Chloride, Bicarbonate, Blood urea nitrogen (BUN), Total Calcium, Phosphorus, Magnesium, Albumin, Prealbumin, Total protein, Creatinine, Alkaline phosphatase, Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Lactate deshydrogenase (LDH), Total bilirubin, Direct bilirubin, Uric Acid.
    • Fasting Lipid Profile: Total cholesterol, Triglycerides, Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL) and Very Low Density Lipoprotein (VLDL)
    • Serum vitamins A, D, E and K.
    • Activated partial thromboplastin time (aPTT), Prothrombin time/International normalized ratio (PT/INR)
    • Immunogenic assessment for circulating levels of LIP2 lipase.
    • Antibodies against LIP2.
    Criterios de valoración de eficacia secundarios:
    Criterios de valoración secundarios claves:
    • Cambio respecto a la Fase B en el número medio de evacuaciones diarias durante los días del periodo de recogida de heces en cada ciclo en la Fase C.
    • Cambio respecto a la Fase B en la consistencia media de las heces evaluadas mediante la escala de Bristol durante el periodo de recogida de
    heces en cada ciclo en la Fase C.

    Criterios de valoración de seguridad secundarios:
    Además de los criterios de valoración de seguridad principales, los resultados
    de las pruebas de laboratorio indicarán:
    • Glucosa en ayunas.
    • Análisis de orina.
    • Hematología: hematocrito, hemoglobina, recuento de eritrocitos, leucocitos, recuentos absolutos de: neutrófilos (segmentados), neutrófilos juveniles (bandas), linfocitos, monocitos, eosinófilos, basófilos y plaquetas.
    • Bioquímica: concentración sérica de: sodio, potasio, cloruro, bicarbonato, nitrógeno ureico en sangre (BUN), calcio total, fósforo, magnesio, albúmina, prealbúmina, proteínas totales, creatinina, fosfatasa alcalina, alanina aminotransferasa (ALT), aspartato aminotransferasa (AST), lactato deshidrogenasa (LDH), bilirrubina total, bilirrubina directa, ácido úrico.
    • Perfil lipídico en ayunas: colesterol total, triglicéridos, lipoproteínas de baja densidad (LDL), lipoproteínas de alta densidad (HDL) y lipoproteínas de muy baja densidad (VLDL)
    • Vitaminas séricas A, D, E y K.
    • Tiempo de tromboplastina parcial activada (aPTT), tiempo de protrombina/índice internacional normalizado (PT/INR)
    • Evaluación inmunogénica de niveles circulantes de lipasa LIP2.
    • Anticuerpos contra LIP2.
    E.5.2.1Timepoint(s) of evaluation of this end point
    V4 - V5 and V6
    V4 - V5 yV6
    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. 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 Yes
    E. trial design description
    Esquema de aumento de dosis
    Escalating doses scheme
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    Ultima visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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 Yes
    F.1.1Number of subjects for this age range: 8
    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) Yes
    F. of subjects for this age range: 8
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 16
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 24
    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)
    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 Decision2020-01-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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