Klinikai vizsgálatok Nct

Summary
EudraCT Number:2022-002788-30
Sponsor's Protocol Code Number:IMVT-1401-3202
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:2023-01-10
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 number2022-002788-30
A.3Full title of the trial
A Phase 3, Multi-center, Randomized, Quadruple-masked, Placebo-controlled Study of Batoclimab for the Treatment of Participants with Active Thyroid Eye Disease (TED)
Estudio de fase III, multicéntrico, aleatorizado, cuádruple ciego y controlado con placebo de batoclimab para el tratamiento de participantes con enfermedad ocular tiroidea (EOT) activa
A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
Phase 3 Study to Assess Batoclimab in Participants with Active Thyroid Eye Disease
Estudio fase III para evalauar Batoclimab en participantes con enfermedad ocular tiroidea (EOT) activa
A.4.1Sponsor's protocol code numberIMVT-1401-3202
A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05524571
A.5.4Other Identifiers
Name:INDNumber:141988
A.7Trial is part of a Paediatric Investigation Plan Yes
A.8EMA Decision number of Paediatric Investigation PlanP/452/2022
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorImmunovant Sciences, GmbH
B.1.3.4CountrySwitzerland
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 supportImmunovant Sciences GmbH
B.4.2CountrySwitzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisationImmunovant Sciences GmbH
B.5.2Functional name of contact pointCentral Study Contact
B.5.3 Address:
B.5.3.1Street AddressViaduktstrasse 8
B.5.3.2Town/ cityBasel
B.5.3.3Post code4051
B.5.3.4CountrySwitzerland
B.5.4Telephone number18007970414
B.5.6E-mailclinicaltrials@immunovant.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 nameBatoclimab
D.3.2Product code IMVT-1401
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 INNBatoclimab
D.3.9.1CAS number 2187430-05-1
D.3.9.2Current sponsor codeIMVT-1401
D.3.9.3Other descriptive nameRVT-1401, HL161BKN, HBM9161
D.3.10 Strength
D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
D.3.10.2Concentration typerange
D.3.10.3Concentration number155 to 185
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 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 placeboSolution for injection in pre-filled syringe
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
Thyroid Eye Disease (TED)
Enfermedad Ocular Tiroidea (EOT)
E.1.1.1Medical condition in easily understood language
Thyroid Eye Disease (TED)
Enfermedad Ocular Tiroidea (EOT)
E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 23.1
E.1.2Level LLT
E.1.2Classification code 10084358
E.1.2Term Thyroid eye disease
E.1.2System Organ Class 100000004853
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 batoclimab 680 mg subcutaneously (SC) once a week (QW) for 12 weeks followed by 340 mg SC QW for 12 weeks versus placebo on proptosis responder rate at Week 24
Evaluar la eficacia de 680 mg de batoclimab por vía subcutánea (s.c.) una vez a la semana (1 v/sem) durante 12 semanas, seguido de 340 mg s.c. 1 v/sem durante 12 semanas, en comparación con placebo en la tasa de respuesta de proptosis en la semana 24.
E.2.2Secondary objectives of the trial
• To evaluate the efficacy of batoclimab compared to placebo as assessed by proptosis and Clinical Activity Score (CAS)
• To evaluate the efficacy of batoclimab compared to placebo as assessed by CAS
• To evaluate the efficacy of batoclimab compared to placebo assessed by change in binding anti-TSHR antibodies (Abs)
• To evaluate the efficacy of batoclimab compared to placebo as assessed by Gorman score for diplopia
• To evaluate the efficacy of batoclimab compared to placebo as assessed by proptosis
• To evaluate the efficacy of batoclimab compared to placebo as assessed by Graves’ ophthalmology-specific quality of life (GO-QOL)
• To evaluate the efficacy of batoclimab compared to placebo as assessed by motility
• Evaluar la eficacia de batoclimab en comparación con placebo evaluada mediante la proptosis y la puntuación de actividad clínica (PAC).
• Evaluar la eficacia de batoclimab en comparación con placebo evaluada mediante PAC.
• Evaluar la eficacia de batoclimab en comparación con placebo evaluada mediante el cambio en los anticuerpos (Ac) de unión anti-TSHR.
• Evaluar la eficacia de batoclimab en comparación con placebo evaluada mediante la puntuación de Gorman para la diplopía.
• Evaluar la eficacia de batoclimab en comparación con placebo evaluada mediante la proptosis.
• Evaluar la eficacia de batoclimab en comparación con placebo evaluada mediante el cuestionario de calidad de vida específica de oftalmología de Graves (GO-QOL).
• Evaluar la eficacia de batoclimab en comparación con placebo evaluada mediante la motilidad.
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
1. Are ≥18 years of age at screening.

2. Have a clinical diagnosis of TED associated with active, moderate to severe TED with a CAS ≥4 in either eye at screening and Baseline.

3. Have moderate to severe active TED, as defined by European Group on Graves' Orbitopathy (EUGOGO) guidelines.

4. Have onset of active TED within 12 months prior to screening.

5. Have documented evidence of detectable anti-TSHR-Ab at screening.

6. Are not expected to require immediate surgical intervention and are not planning corrective surgery/irradiation or medical therapy for TED during the course of the study.

7. Are euthyroid with the baseline disease under control or have mild hypo- or hyperthyroidism.

Additional inclusion criteria are defined in the protocol.
1. Tener ≥ 18 años en la selección.

2. Tener un diagnóstico clínico de EOT asociada a EOT activa, moderada o grave, con una PAC ≥4 en cualquiera de los ojos en la selección y al inicio.

3. Tener EOT activa moderada o grave (que no pone en riesgo la vista, pero tiene un impacto apreciable en la vida diaria), según la definición de las directrices del grupo europeo en orbitopatía de Graves (EUGOGO).

4. Tener el inicio de la EOT activa en los 12 meses anteriores a la selección.

5. Tener evidencia documentada de anticuerpos anti-TSHR detectables en la selección.

6. No se espera que requiera intervención quirúrgica inmediata y no tiene planificada una cirugía o irradiación correctiva ni tratamiento médico para la EOT durante el transcurso del estudio.

7. Tener eutiroidismo con la enfermedad inicial bajo control o tener hipotiroidismo o hipertiroidismo leves.

En el protocolo se definen los demás criterios de inclusión.
E.4Principal exclusion criteria
1. Have decreased best corrected visual acuity due to optic neuropathy.

2. Have at least a 2-point decrease in CAS or ≥2 mm decrease in proptosis between screening and Baseline assessments in either eye.

3. Have used any steroid (intravenous or oral) for the treatment of TED or other conditions within 4 weeks prior to screening.

4. Have used any steroid (Intravenous or oral) with a cumulative dose equivalent to ≥ 1 g of methylprednisolone for the treatment of TED.

5. Have known autoimmune disease other than TED, that, in the opinion of the Investigator, would interfere with the course and conduct of the study.

6. Had previous orbital irradiation or surgery for TED.

Additional exclusion criteria are defined in the protocol.
1. Tener disminución de la mejor agudeza visual corregida debido a neuropatía óptica.

2. Tener al menos una disminución de 2 puntos en la PAC o una disminución de ≥2 mm en la proptosis entre las evaluaciones de selección e inicio en cualquiera de los ojos.

3. Tener enfermedad autoinmunitaria conocida distinta de la EOT, que, en opinión del investigador, interferiría con el transcurso y la realización del estudio.

4. Haber utilizado algún corticoesteroide (intravenoso u oral) para el tratamiento de la EOT u otras afecciones en las 4 semanas anteriores a la selección.

5. Haber utilizado cualquier corticoesteroide (intravenoso u oral) con una dosis acumulada equivalente a ≥1 g de metilprednisolona para el tratamiento de la EOT.

6. Haber recibido irradiación o cirugía orbital previa para la EOT.

En el protocolo se definen los demás criterios de exclusión.
E.5 End points
E.5.1Primary end point(s)
Proportion of proptosis responders (proptosis responder rate) at Week 24 where proptosis responder is defined as the participant with a ≥ 2 mm reduction in the study eye without deterioration (≥ 2 mm increase) in the fellow eye
Proporción de pacientes con respuesta de proptosis (tasa de respuesta de proptosis) en la semana 24, donde el paciente con respuesta de proptosis se define como el participante con una reducción ≥2 mm en el ojo del estudio, sin deterioro (aumento ≥2 mm) en el otro ojo.
E.5.1.1Timepoint(s) of evaluation of this end point
Week 24
Semana 24
E.5.2Secondary end point(s)
• Proportion of participants with proptosis ≥ 2 mm reduction and CAS of ≤ 3 at Week 24 from baseline in the study eye
• Proportion of participants with CAS of 0 or 1 at Week 24 in the study eye
• Mean change from baseline to Week 24 in CAS in the study eye
• Proportion of participants with positive binding anti-TSHR Ab at baseline who achieve seroconversion at Week 24
• Proportion of participants with decrease of at least 1 grade from baseline in Gorman score for diplopia at Week 24 in participants who have diplopia at baseline.
• Mean change from baseline to Week 24 in proptosis (mm) in the study eye
• Proportion of participants with ≥ 6-point increase from baseline in total GO-QOL score at Week 24 in participants who have the ability to increase by ≥ 6-points from baseline
• Proportion of participants with ≥ 8-degree increase from baseline in motility (in at least 1 of 4 directions) at Week 24 in the study eye in participants who have the ability to increase by ≥ 8 degrees from baseline.
• Proporción de participantes con reducción de la proptosis ≥2 mm y PAC ≤3 en la semana 24 con respecto al inicio en el ojo del estudio.
• Proporción de participantes con PAC de 0 o 1 en la semana 24 en el ojo del estudio.
• Cambio medio en la PAC del ojo del estudio con respecto al inicio hasta la semana 24.
• Proporción de participantes con Ac de unión anti-TSHR positivos al inicio que logran la seroconversión en la semana 24.
• Proporción de participantes con una disminución de al menos 1 grado con respecto al inicio en la puntuación de Gorman para la diplopía en la semana 24, en los participantes que tienen diplopía al inicio.
• Cambio medio en la proptosis (mm) del ojo del estudio con respecto al inicio hasta la semana 24.
• Proporción de participantes con un aumento ≥6 puntos con respecto al inicio en la puntuación total de GO-QOL en la semana 24, en los participantes que tienen la capacidad de aumentar en ≥6 puntos con respecto al inicio.
• Proporción de participantes con un aumento ≥8 grados con respecto al inicio en la motilidad (al menos en 1 de las 4 direcciones) del ojo del estudio en la semana 24, en los participantes que tienen la capacidad de aumentar en ≥8 grados con respecto al inicio.
E.5.2.1Timepoint(s) of evaluation of this end point
Week 24
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 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
healthcare economic outcome measures
medida de los resultados económicos de la asistencia sanitaria
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 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 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 concerned7
E.8.5The trial involves multiple Member States Yes
E.8.5.1Number of sites anticipated in the EEA18
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
Canada
Japan
United States
Austria
Latvia
Spain
Switzerland
Czechia
Germany
Belgium
Hungary
Slovakia
Turkey
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 defined as the date of the last visit of the last participant in the study.
El final del estudio se define como la fecha de la última visita del último participante en el estudio.
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 months3
E.8.9.1In the Member State concerned days11
E.8.9.2In all countries concerned by the trial years2
E.8.9.2In all countries concerned by the trial months3
E.8.9.2In all countries concerned by the trial days11
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: 90
F.1.3Elderly (>=65 years) Yes
F.1.3.1Number of subjects for this age range: 10
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 state10
F.4.2 For a multinational trial
F.4.2.1In the EEA 34
F.4.2.2In the whole clinical trial 100
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 will have the option to enroll in study IMVT-1401-3203.
Los participantes tendrán la opción de incluirse en el estudio IMVT-1401-3203.
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 Decision2023-04-12
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2023-02-02
P. End of Trial
P.End of Trial StatusOngoing

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