Clinical Trials Nct-pagina

Summary
EudraCT Number:2021-005528-39
Sponsor's Protocol Code Number:78934804UCO2001
National Competent Authority:Spain - AEMPS
Clinical Trial Type:EEA CTA
Trial Status:Ongoing
Date on which this record was first entered in the EudraCT database:2022-08-17
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 number2021-005528-39
A.3Full title of the trial
A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis
Estudio de fase 2b, aleatorizado, en doble ciego, controlado con principio activo y con placebo, de grupos paralelos y multicéntrico, para evaluar la eficacia y la seguridad de la combinación de guselkumab y golimumab como tratamiento de inducción y de mantenimiento en participantes con colitis ulcerosa activa de grado moderado o severo
A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
Efficacy and Safety of Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis
Eficacia y seguridad de la terapia de combinación de guselkumab y golimumab en participantes con colitis ulcerosa de grado moderado o severo.
A.3.2Name or abbreviated title of the trial where available
DUET-UC
A.4.1Sponsor's protocol code number78934804UCO2001
A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05242484
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 LLC
B.5.2Functional name of contact point-
B.5.3 Address:
B.5.3.1Street Address-
B.5.3.2Town/ city-
B.5.3.3Post code-
B.5.3.4CountrySpain
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 nameJNJ-78934804
D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
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 number50
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNGolimumab
D.3.9.1CAS number 476181-74-5
D.3.9.2Current sponsor codeCNTO148
D.3.9.3Other descriptive nameGolimumab
D.3.9.4EV Substance CodeSUB25638
D.3.10 Strength
D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number50
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 typeCombination of the monoclonal antibodies Guselkumab and Golimumab
D.IMP: 2
D.1.2 and D.1.3IMP RoleComparator
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 in pre-filled syringe
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: 3
D.1.2 and D.1.3IMP RoleComparator
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 nameGolimumab
D.3.2Product code CNTO148
D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
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 INNGolimumab
D.3.9.1CAS number 476181-74-5
D.3.9.2Current sponsor codeCNTO148
D.3.9.3Other descriptive nameGolimumab
D.3.9.4EV Substance CodeSUB25638
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 in vial
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
Moderately to Severely Active Ulcerative Colitis
Colitis ulcerosa activa de grado moderado o severo
E.1.1.1Medical condition in easily understood language
Inflammatory bowel disease (IBD)
Enfermedad inflamatoria intestinal (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 20.1
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 efficacy of JNJ-78934804 at Week 48 compared with each monotherapy (guselkumab alone and golimumab alone)
Evaluar la eficacia de JNJ-78934804 en la semana 48 frente a cada producto en monoterapia (guselkumab solo y golimumab solo)
E.2.2Secondary objectives of the trial
1 To evaluate the efficacy of JNJ-78934804 compared with each monotherapy across a range of outcome measures
2 To evaluate the efficacy of JNJ-78934804 at Week 24 compared with placebo
3 To evaluate the safety of JNJ-78934804 compared with each monotherapy and placebo
4 To evaluate the pharmacokinetics (PK) and immunogenicity of JNJ-78934804 compared with each monotherapy
1. Evaluar la eficacia de JNJ-78934804 frente a cada producto en monoterapia en cuanto a diversos resultados
2. Evaluar la eficacia de JNJ-78934804 en la semana 24 frente al placebo
3. Evaluar la seguridad de JNJ-78934804 frente a cada producto en monoterapia y frente al placebo
4. Evaluar la farmacocinética (pharmacokinetics, PK) y la inmunogenia de JNJ-78934804 frente a cada producto en monoterapia
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
•Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to baseline
•Moderately to severely active UC as assessed by the modified mayo score
•Demonstrated inadequate response, loss of response, or intolerance to at least one biologic or novel oral with biologic-like activity
•If female and of childbearing potential, must meet the contraception and reproduction requirements


For an overview of all the inclusion criteria please refer to protocol section 5.1
- Diagnosis confirmada de colitis ulcerosa (CU) durante al menos 3 meses antes de la referencia.
- CU activa de moderada a severa determinada por la escala Mayo modificada.
- Respuesta inadecuada demostrada, perdida de respuesta o intolerancia a al menos un tratamiento biológico o tratamiento oral novedoso con actividad similar a la de un biológico.
- Si el paciente es mujer y con potencial de concebir, debe cumplir los requerimientos de reproducción y de anticoncepción.

Para un resumen de todos los criterios de inclusión, refiérase a la sección 5.1 del protocolo.
E.4Principal exclusion criteria
•Has severe extensive colitis as defined in the protocol
•Extent of inflammatory disease limited to the rectum
•Participants with current diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or crohn's disease (CD)
•Has a history of, or ongoing, chronic or recurrent infectious disease
•Currently has a malignancy or a history of malignancy within 5 years before screening (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ that has been treated with no evidence of recurrence within 12 months of first dose of study intervention)


For an overview of all the exclusion criteria please refer to protocol section 5.2
- Tiene colitis extensiva severa como se define en el protocolo.
- La extensión de la enfermedad inflamatoria de limita al recto.
- Pacientes con una diagnosis actual de colitis indeterminada, colitis microscópica, colitis isquémica o enfermedad de Crohn (EC).
- Tiene un historial de, o padece actualmente, una enfermedad infecciosa crónica o recurrente.
- Actualmente tiene un tumor maligno o un historial de tumor/es maligno/s en los 5 años previos a la selección (con la excepción de cáncer de piel no melanoma o carcinoma de cuello uterino in situ que haya sido tratado sin evidencia de recurrencia dentro de los 12 meses posteriores a la primera dosis de la intervención del estudio)


Para un resumen de todos los criterios de inclusión, refiérase a la sección 5.2 del protocolo.
E.5 End points
E.5.1Primary end point(s)
Clinical remission at Week 48
Remisión clínica en la semana 48
E.5.1.1Timepoint(s) of evaluation of this end point
At Week 48
En la semana 48
E.5.2Secondary end point(s)
1 Combination of histological remission and endoscopic improvement
2 Clinical remission of JNJ-78934804 at Week 24 compared with placebo
3 Frequency and type of AEs, serious adverse events (SAEs)
4 Serum concentrations of guselkumab and golimumab over time
5 Incidence and titers of antibodies to guselkumab and golimumab
6 Incidence of neutralizing antibodies to guselkumab and golimumab
1. Combinación de remisión histológica y mejora endoscópica
2. Remisión clínica de JNJ-78934804 en la semana 24 comparada con placebo
3. Frecuencia y tipo de acontecimientos adversos (adverse events, AE) y acontecimientos adversos graves (serious adverse events, SAE)
4. Concentraciones séricas de guselkumab y golimumab a lo largo del tiempo
5. Incidencia y títulos de anticuerpos contra el guselkumab y golimumab
6. Incidencia de anticuerpos neutralizantes contra el guselkumab y golimumab
E.5.2.1Timepoint(s) of evaluation of this end point
1 - At Week 48
2 - At Week 24
1- En la semana 48
2- En la semana 24
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 Yes
E.6.4Safety Yes
E.6.5Efficacy Yes
E.6.6Pharmacokinetic Yes
E.6.7Pharmacodynamic Yes
E.6.8Bioequivalence No
E.6.9Dose response Yes
E.6.10Pharmacogenetic No
E.6.11Pharmacogenomic Yes
E.6.12Pharmacoeconomic No
E.6.13Others Yes
E.6.13.1Other scope of the trial description
Immunogenicity
Inmunogenicidad
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) Yes
E.8.2.2Placebo Yes
E.8.2.3Other Yes
E.8.2.3.1Comparator description
Guselkumab y Golimumab (Monoterapia)
Guselkumab and Golimumab (Monotherapy)
E.8.2.4Number of treatment arms in the trial6
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 concerned8
E.8.5The trial involves multiple Member States Yes
E.8.5.1Number of sites anticipated in the EEA115
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
Argentina
Australia
Brazil
Canada
Chile
China
Egypt
Hong Kong
India
Israel
Japan
Jordan
Korea, Republic of
Malaysia
Mexico
New Zealand
Taiwan
United States
Austria
Estonia
Finland
France
Latvia
Lithuania
Poland
Sweden
Bulgaria
Netherlands
Spain
Switzerland
Czechia
Germany
Greece
Italy
Belgium
Bosnia and Herzegovina
Croatia
Denmark
Georgia
Hungary
Ireland
Norway
Portugal
Russian Federation
Slovakia
Slovenia
Turkey
Ukraine
United Kingdom
Serbia
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
The end of study is considered as the last scheduled study assessment shown in the SoA ( Schedule of activities) for the last participant or if a decision has been made by the sponsor not to pursue an indication in UC and appropriate follow-up has been completed.
Se considerará que se ha alcanzado el fin del estudio cuando el último participante se haya sometido a la última evaluación programada del estudio que se muestra en el Calendario de actividades (Schedule of activities, SoA) o si el promotor toma la decisión de no proseguir el desarrollo en la indicación de CU y se ha completado el seguimiento
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 months9
E.8.9.1In the Member State concerned days0
E.8.9.2In all countries concerned by the trial years5
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: 550
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 state24
F.4.2 For a multinational trial
F.4.2.1In the EEA 118
F.4.2.2In the whole clinical trial 550
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)
Participants who complete treatment and who are eligible for continued access program (post- study access or other open-label extension study under a different/separate protocol), all others participants will return to their normal treatment.
Los participantes que completen el tratamiento y que sean elegibles para ello, pasarán al programa de acceso continuo (acceso posterior al estudio o un estudio de extensión abierto bajo un protocolo diferente/separado); todos los demás participantes volverán a su tratamiento normal.
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 Decision2022-11-25
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2022-10-13
P. End of Trial
P.End of Trial StatusOngoing

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