Stránka klinických studií Nct

Summary
EudraCT Number:2022-002389-33
Sponsor's Protocol Code Number:CNTO1959CRD3007
National Competent Authority:Spain - AEMPS
Clinical Trial Type:EEA CTA
Trial Status:Temporarily Halted
Date on which this record was first entered in the EudraCT database:2023-01-12
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
A. Protocol Information
A.1Member State ConcernedSpain - AEMPS
A.2EudraCT number2022-002389-33
A.3Full title of the trial
A Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Guselkumab for the Treatment of Participants with Crohn’s Disease After Surgical Resection
Estudio aleatorizado, en doble ciego y controlado con placebo, para evaluar la seguridad y la eficacia del guselkumab en el tratamiento de participantes con enfermedad de Crohn tras la resección quirúrgica
A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
Prevention of Recurrence post Operatively with Guselkumab Relative to Endoscopy and Symptoms
Prevención de la recurrencia postoperatoria con guselkumab en relación a la endoscopia y los síntomas
A.3.2Name or abbreviated title of the trial where available
PROGRESS
PROGRESS
A.4.1Sponsor's protocol code numberCNTO1959CRD3007
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 SponsorJanssen-Cilag International 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 supportJanssen Research & Development
B.4.2CountryUnited States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisationParexel International
B.5.2Functional name of contact pointClinical Trial Information
B.5.3 Address:
B.5.3.1Street Address70 Sir John Rogerson's Quay
B.5.3.2Town/ cityDublin
B.5.3.3Post code2
B.5.3.4CountryIreland
B.5.6E-mailclinicaltrial.enquiries@parexel.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 nameGuselkumab
D.3.2Product code CNTO1959
D.3.4Pharmaceutical form Solution for injection
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPSubcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNGuselkumab
D.3.9.2Current sponsor codeCNTO1959
D.3.9.3Other descriptive nameGuselkumab
D.3.9.4EV Substance CodeSUB179789
D.3.10 Strength
D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number100
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.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 Yes
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 Yes
D.3.11.13.1Other medicinal product typeMonoclonal antibody
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 nameGuselkumab
D.3.2Product code CNTO1959
D.3.4Pharmaceutical form Solution for injection
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPSubcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNGuselkumab
D.3.9.2Current sponsor codeCNTO1959
D.3.9.3Other descriptive nameGuselkumab
D.3.9.4EV Substance CodeSUB179789
D.3.10 Strength
D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number100
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.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 Yes
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 Yes
D.3.11.13.1Other medicinal product typeMonoclonal antibody
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 placeboSolution for injection
D.8.4Route of administration of the placeboSubcutaneous use
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Crohn’s Disease After Surgical Resection
Enfermedad de Crohn después de resección quirúrgica
E.1.1.1Medical condition in easily understood language
Inflammatory bowel disease (IBD)
Enfermedad intestinal inflamatoria (EII)
E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 20.0
E.1.2Level PT
E.1.2Classification code 10011401
E.1.2Term Crohn's disease
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 efficacy of guselkumab treatment versus placebo in preventing endoscopic recurrence of CD in participants after surgery
Evaluar la eficacia del tratamiento con guselkumab frente al placebo para prevenir la recurrencia endoscópica de la CD en los participantes después de la cirugía
E.2.2Secondary objectives of the trial
- To evaluate clinical remission without disease recurrence in participants treated with guselkumab versus placebo after surgery
- To evaluate disease recurrence in participants treated with guselkumab versus placebo after surgery
- To evaluate symptoms such as stool frequency and abdominal pain scores in guselkumab versus placebo after surgery
- To evaluate the safety of guselkumab in participants with CD in the postoperative period
- The evaluate the efficacy of guselkumab in limiting steroid use and preventing clinical recurrence of patients in clinical remission
- Evaluar la remisión clínica sin recurrencia de la enfermedad en los participantes tratados con guselkumab, frente a placebo, después de la cirugía
- Evaluar la recurrencia de la enfermedad en los participantes tratados con guselkumab, frente a placebo, después de la cirugía
- Evaluar los síntomas como la frecuencia de las deposiciones y las puntuaciones de dolor abdominal en los participantes tratados con guselkumab, frente a placebo, después de la cirugía
- Evaluar la seguridad del guselkumab en participantes con CD en el periodo posoperatorio
- Evaluar la eficacia del guselkumab en la reducción del uso de corticosteroides y en la prevención de la recurrencia clínica de los pacientes en remisión clínica
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
1. Participants ≥18 (or the legal age of consent in the jurisdiction in which the study is taking place).
2. Have a documented diagnosis of CD confirmed by endoscopic, histologic, and/or radiologic studies prior to resection or by tissue obtained at resection.
3. Have undergone an ileocolonic surgical resection (ie, an intestinal resection with an ileocolonic anastomosis) for CD with the following criteria:
- Have no known active CD anywhere in the gastrointestinal (GI) tract, including the findings at surgery,
- Be able to undergo randomization no later than 49 days after surgery, and at least 10 days after surgery (or 8 days after resumption of bowel activity, eg, in case of postoperative ileus),
- Ileocolonic resection was not for the purpose of removing known dysplasia,
- If ileocolonic resection occurs > 10 years since the diagnosis of CD and only fibrostenotic stricturing is present, then length of stricture must be > 10 cm
4. Have a baseline CDAI < 200.

Please refer to protocol for the complete list of inclusion criteria.
1. Participantes >= 18 (o la edad legal de consentimiento en la jurisdicción en la que se lleva a cabo el estudio).
2. Tener un diagnóstico documentado de Enfermedad de Crohn (EC) confirmado por estudios endoscópicos, histológicos y/o radiológicos antes de la resección o por tejido obtenido en la resección.
3. Haber sido sometido a una resección quirúrgica ileocolónica (es decir, una resección intestinal con una anastomosis ileocolónica) por EC con los siguientes criterios:
- No tener EC activa conocida en ninguna parte del tracto gastrointestinal (GI), incluidos los hallazgos en la cirugía,
- Ser capaz de someterse a la aleatorización a más tardar 49 días después de la cirugía y al menos 10 días después de la cirugía (u 8 días después de la reanudación de la actividad intestinal, por ejemplo, en caso de íleo posoperatorio),
- La resección ileocolónica no fue con el propósito de eliminar la displasia conocida,
- Si la resección ileocolónica ocurre > 10 años desde el diagnóstico de EC y solo hay estenosis fibroestenótica, entonces la longitud de la estenosis debe ser > 10 cm
4. Tener un CDAI basal < 200.

Consulte el protocolo para ver la lista completa de criterios de inclusión.
E.4Principal exclusion criteria
1. Has complications of CD, such as symptomatic strictures or stenoses, short bowel syndrome, a draining (ie, functioning) stoma or ostomy, or any other manifestation, that might be anticipated to require surgery, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with guselkumab.
2. Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before baseline, or 8 weeks before baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery.
3. Have had any active perianal disease within 3 months of screening (except skin tags) or have had any draining fistula within 3 months of screening unless the fistula was removed at the index surgery.
4. Had, in association with their most recent intra-abdominal surgery, postoperative complications such as, but not limited to, postoperative intraabdominal abscess, wound dehiscence, anastomotic leak, the need for a second operation, or have evidence of macroscopically active CD which was not resected at the time of surgery or had active CD in regions beyond the site of surgery in the GI tract within 1 year of the time of enrolment.

7. Has or has had any other clinically significant infection (eg, hepatitis, sepsis, pneumonia, or pyelonephritis, enteric infection), within 8 weeks before the first dose of study intervention. Treated and resolved infections, not considered clinically significant at the discretion of the investigator need not be exclusionary (ie, acute upper respiratory tract infection, uncomplicated urinary tract infection, and clinically resolved infections related to the participant’s Crohn’s-related surgical resection).

Please refer to protocol for the complete list of exclusion criteria.
1. Tiene complicaciones de EC, como estenosis o estenosis sintomáticas, síndrome de intestino corto, un estoma u ostomía que drena (es decir, funciona), o cualquier otra manifestación, que pueda anticiparse que requiera cirugía, podría impedir el uso del CDAI para evaluar la respuesta al tratamiento, o posiblemente confundiría la capacidad de evaluar el efecto del tratamiento con guselkumab.
2. Actualmente tiene o se sospecha que tiene un absceso. Los abscesos cutáneos y perianales recientes no son excluyentes si se drenan y tratan adecuadamente al menos 3 semanas antes del inicio, u 8 semanas antes del inicio para los abscesos intraabdominales, siempre que no haya necesidad anticipada de cirugía adicional.
3. Haber tenido alguna enfermedad perianal activa dentro de los 3 meses previos a la selección (excepto papilomas cutáneos) o haber tenido alguna fístula con drenaje dentro de los 3 meses previos a la selección, a menos que la fístula se haya extirpado en la cirugía índice.
4. Tuvo, en asociación con su cirugía intraabdominal más reciente, complicaciones posoperatorias como, entre otras, absceso intraabdominal posoperatorio, dehiscencia de la herida, fuga anastomótica, la necesidad de una segunda operación o evidencia de EC macroscópicamente activa que no fue resecado en el momento de la cirugía o tenía EC activa en regiones más allá del sitio de la cirugía en el tracto GI dentro de 1 año del momento de la inscripción.

7. Tiene o ha tenido cualquier otra infección clínicamente significativa (p. ej., hepatitis, sepsis, neumonía o pielonefritis, infección entérica), dentro de las 8 semanas anteriores a la primera dosis de la intervención del estudio. Las infecciones tratadas y resueltas, que no se consideren clínicamente significativas a discreción del investigador, no necesitan ser excluyentes (es decir, infección aguda de las vías respiratorias superiores, infección del tracto urinario sin complicaciones e infecciones resueltas clínicamente relacionadas con la resección quirúrgica relacionada con la enfermedad de Crohn del participante).

Consulte el protocolo para ver la lista completa de criterios de exclusión.
E.5 End points
E.5.1Primary end point(s)
Endoscopic Recurrence as defined by a modified Rutgeerts score of i2a or greater
Recurrencia endoscópica en la semana definida por una puntuación de Rutgeerts modificada de i2a o mayor.
E.5.1.1Timepoint(s) of evaluation of this end point
Week 48
Semana 48
E.5.2Secondary end point(s)
- Clinical remission without disease recurrence at Week 48
- Time-to-disease recurrence at the main study database lock
- Abdominal pain free at Week 48
- Time-to-recurrence of symptoms
- Frequency and type of AEs and serious adverse events
- Steroid free clinical remission at Week 48
- Remisión clínica sin recurrencia de la enfermedad en la semana 48
- Tiempo hasta la recurrencia de la enfermedad en el bloqueo de la base de datos del estudio principal
- Sin dolor abdominal en la semana 48
- Tiempo hasta la recurrencia de los síntomas
- Frecuencia y tipo de EA y eventos adversos graves
- Remisión clínica libre de esteroides en la semana 48
E.5.2.1Timepoint(s) of evaluation of this end point
Week 48 or as otherwise noted
Semana 48 o según se indique
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) 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 concerned9
E.8.5The trial involves multiple Member States Yes
E.8.5.1Number of sites anticipated in the EEA88
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
Australia
Canada
Korea, Republic of
United States
Austria
France
Poland
Netherlands
Spain
Czechia
Germany
Italy
Belgium
Hungary
United Kingdom
Serbia
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 years4
E.8.9.1In the Member State concerned months1
E.8.9.1In the Member State concerned days27
E.8.9.2In all countries concerned by the trial years4
E.8.9.2In all countries concerned by the trial months7
E.8.9.2In all countries concerned by the trial days27
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: 300
F.1.3Elderly (>=65 years) Yes
F.1.3.1Number of subjects for this age range: 70
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 state36
F.4.2 For a multinational trial
F.4.2.1In the EEA 219
F.4.2.2In the whole clinical trial 370
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)
Patients who end their participation in the trial will return to their primary physician to determine standard of 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 Decision2023-03-27
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2023-01-31
P. End of Trial
P.End of Trial StatusTemporarily Halted

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