Clinical Trials Register

Summary
EudraCT Number:	2017-000372-29
Sponsor's Protocol Code Number:	JBT101-SSc-002
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:	2018-02-02
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

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2017-000372-29

A.3

Full title of the trial

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis

Ensayo de fase 3 multicéntrico, aleatorizado, doble ciego, controlado con placebo para evaluar la eficacia y la seguridad de lenabasum en la esclerosis sistémica cutánea difusa

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A study of safety and efficacy of lenabasum in Systemic Sclerosis

Estudio de seguridad y eficacia de lenabasum en la esclerosis sistémica

A.3.2

Name or abbreviated title of the trial where available

A Phase 3 safety and efficacy study of Lenabasum in Systemic Sclerosis

Estudio de fase 3 de Estudio de seguridad y eficacia de lenabasum en la esclerosis sistémica

A.4.1

Sponsor's protocol code number

JBT101-SSc-002

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Corbus pharmaceuticals Inc.
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Corbus Pharmaceuticals, Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	TMC Pharma Services Ltd
B.5.2	Functional name of contact point	Regulatory Services
B.5.3	Address:
B.5.3.1	Street Address	Lodge Farm Barn, Elvetham Park Estate, Fleet Road
B.5.3.2	Town/ city	Hartley Wintney, Hampshire
B.5.3.3	Post code	RG27 8AS
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	+441252842255
B.5.5	Fax number	+441252842277
B.5.6	E-mail	regulatory.services@tmcpharma.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	Yes
D.2.5.1	Orphan drug designation number	EU/3/16/1808
D.3 Description of the IMP
D.3.1	Product name	Lenabasum 5 mg Powder in Capsule
D.3.2	Product code	JBT-101
D.3.4	Pharmaceutical form	Capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Lenabasum
D.3.9.1	CAS number	137945-48-3
D.3.9.2	Current sponsor code	JBT-101
D.3.9.3	Other descriptive name	resunab, ajulemic acid, anabasum
D.3.9.4	EV Substance Code	SUB178399
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	5 to 20
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	Yes
D.2.5.1	Orphan drug designation number	EU/3/16/1808
D.3 Description of the IMP
D.3.1	Product name	Lenabasum 20 mg Powder in Capsule
D.3.2	Product code	JBT-101
D.3.4	Pharmaceutical form	Capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Lenabasum
D.3.9.1	CAS number	137945-48-3
D.3.9.2	Current sponsor code	JBT-101
D.3.9.3	Other descriptive name	resunab, ajulemic acid, anabasum
D.3.9.4	EV Substance Code	SUB178399
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	5 to 20
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Systemic Sclerosis (SSc)

Esclerodermia

E.1.1.1

Medical condition in easily understood language

A disease of the immune system attacking the connective tissue under the skin and around internal organs and blood vessels causing scarring and thickening of the tissue in these areas.

Una enfermedad del sistema inmune que ataca el tejido conectivo subcutáneo y que rodea rodea los oganos internos y vasos sanguineos causando cicatrización y engrosamiento del tejido en esas areas.

E.1.1.2

Therapeutic area

Body processes [G] - Immune system processes [G12]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10012977
E.1.2	Term	Diffuse systemic sclerosis
E.1.2	System Organ Class	100000004859

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the efficacy of lenabasum compared to placebo in the treatment of diffuse cutaneous systemic sclerosis (SSc) by assessing change from baseline in the modified Rodnan skin score (mRSS) at Week 52

Evaluar la eficacia de lenabasum en comparación con placebo en el tratamiento de la esclerosis sistémica (ES) cutánea difusa mediante la evaluación de la variación respecto al momento basal de la puntuación de la escala cutánea de Rodnan modificada (mRSS) en la semana 52

E.2.2

Secondary objectives of the trial

1. To evaluate the efficacy of lenabasum compared to placebo in the treatment of SSc by assessing the change from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) score at Week 52.
2. To evaluate the efficacy of lenabasum compared to placebo in the treatment of SSc by assessing the American College of Rheumatology (ACR) Provisional Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) score at Week 52.
3. To evaluate the efficacy of lenabasum compared to placebo in the treatment of SSc by assessing the change from baseline in the forced vitality capacity (FVC) % score at Week 52.

1. Evaluar la eficacia de lenabasum en comparación con placebo en el tratamiento de la ES mediante la evaluación de la variación respecto al momento basal de la puntuación del Cuestionario de evaluación de la salud-Índice de discapacidad (HAQ-DI) en la semana 52.
2. Evaluar la eficacia de lenabasum en comparación con placebo en el tratamiento de la ES mediante la evaluación de la puntuación del Índice de la respuesta combinada provisional en la esclerosis sistémica cutánea difusa (CRISS) del Colegio americano de reumatología (ACR, American College of Rheumatology) en la semana 52.
3. Evaluar la eficacia de lenabasum en comparación con placebo en el tratamiento de la ES mediante la evaluación de la variación respecto al momento basal del porcentaje del valor teórico de la capacidad vital forzada (CVF) en la semana 52.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Fulfills the 2013 American College of Rheumatology criteria for systemic sclerosis (van den Hoogen et al, 2013).
2. Diffuse cutaneous SSc (skin thickening on upper arms proximal to the elbows, upper legs proximal to the knees, or trunk).
3. ≥ 18 years of age at the time Informed Consent is signed.
4. Written informed consent from the subject.
5. Disease duration ≤ 6 years from the first non-Raynaud’s symptom. If disease duration is > 3 years and ≤ 6 years, then mRSS ≥ 15. Subjects with disease duration > 3 years and ≤ 6 years and mRSS ≥ 15 will be limited to no more than 1/3rd of the subjects.
6. Patient Global Assessment ≥ 3 or MDGA ≥ 3.
7. Overlap with polymyositis, systemic lupus erythematosus, Sjogren’s syndrome, or rheumatoid arthritis is allowed only if the dominant clinical disease is diffuse cutaneous SSc.
8. Stable treatment for SSc ≥ 28 days before Visit 1.
9. Willing to not start or stop any immunosuppressive medications for SSc from Visit 1 through Visit 11, unless a change is considered in the subject’s best medical interest by the site investigator or another physician who has primary responsibility for treating the subject’s SSc.
10. Willing not to use any cannabinoids including recreational marijuana, medical marijuana and other prescription cannabinoids from Screening through Visit 11.
11. Women of childbearing potential must not be pregnant or breastfeeding at Visit 1 and must be using at least one highly effective method of contraception (failure rate < 1% per year) for
at least 28 days before Visit 1 and be willing to continue to use at least one highly effective method of contraception throughout the study and for at least 28 days after discontinuation of study product.
12. Male participants must be willing to follow contraceptive requirements and should not get anyone pregnant while they are taking the study drug or within 28 days after taking the last dose of the study drug, during which time period they or their partner must be willing to use at least one highly effective method of contraception.
13. Able to adhere to the study visit schedule and other protocol requirements.

1. Cumplir con los criterios del American College of Rheumatology criteria for systemic sclerosis 2013 para la esclerosis sistémica (van den Hoogen et al, 2013).
2. ES cutánea difusa (engrosamiento de la piel en la parte superior de los brazos, la parte superior de las piernas o el tronco).
3. ≥ 18 años de edad en el momento de la firma del consentimiento informado.
4. Consnetimiento informado escrito del paciente
5. Duración de la enfermedad ≤ 6 años desde la aparición del primer síntoma que no corresponde al fenómeno de Raynaud. Si la duración de la enfermedad es > 3 años y ≤ 6 años, entonces mRSS ≥ 15.
6. Evaluación global del paciente ≥ 3 o MDGA ≥ 3.
7. La superposición con la polimiositis, lupus eritematoso sistémico, l síndrome de Sjogren o artritis reumatoide solo se permite si la enfermedad clínica dominante es la ES cutánea difusa.
8. Tratamiento estable para ES ≥ 28 días antes de la Visita 1.
9. Disposición a no comenzar o suspender ningún medicamento inmunosupresor para ES desde la Visita 1 hasta la Visita 11, a menos que un cambio sea considerado lo mejor por el investigador del centro u otro médico que tenga la responsabilidad principal de tratar la ES.
10. Disposición a no usar ningún cannabinoide incluyendo marihuana recreativa, marihuana medicinal y otros cannabinoides recetados desde la Selección hasta la Visita 11.
11. Las mujeres en edad fértil no deben estar embarazadas o dando el pecho en la visita 1 y deben usar al menos un método anticonceptivo altamente eficaz (tasa de fracaso <1% por año) durante al menos 28 días antes de la visita 1 y estar dispuestos a continuar.
12. Los participantes masculinos deben estar dispuestos a seguir los requisitos anticonceptivos y no deben dejar embarazada a nadie mientras toman el medicamento del estudio o dentro de los 28 días posteriores a la última dosis del medicamento del estudio, durante los cuales su pareja o ellos deben estar dispuestos a usarlos.
13. Ser capaz cumplir con el calendario de visitas de estudio y otros requisitos de protocolo.

E.4

Principal exclusion criteria

1. Unstable SSc or SSc with end-stage organ involvement at Screening or Visit 1, such as:
a. On an organ transplantation list or has received an organ transplant
b. Renal crisis within 1 year
c. Interstitial lung disease requiring constant oxygen treatment. This excludes oxygen used to aid sleep or exercise.
d. Pulmonary hypertension requiring constant oxygen treatment. This excludes oxygen used to aid sleep or exercise.
e. Gastrointestinal dysmotility requiring total parenteral nutrition or hospitalization within 6 months before Visit 1.
2. Certain medications at Screening or Visit 1, including:
a. Treatment with any oral prednisone > 10 mg per day or equivalent within 28 days before Visit 1. Treatment with intravenous corticosteroids within 28 days before Visit 1 is not allowed, and treatment with intra-articular corticosteroids within 28 days before Visit 1 is allowed.
b. New or increase in doses of any non-corticosteroid immunosuppressive medication within 8 weeks before Screening.
c. Treatment with cyclophosphamide within 3 months before Visit 1.
3. Patients with SSc-like illnesses related to exposures or ingestions.
4. Significant diseases or conditions other than SSc that may influence response to the study product or safety, such as:
a. A new bacterial or viral infection that was treated with oral or intravenous antibiotics or anti-viral treatments within 28 days before Visit 1. This does not include prophylactic antibiotic or anti-viral treatments.
b. Acute or chronic hepatitis B or C infection.
c. Human immunodeficiency virus (HIV) infection.
d. History of active tuberculosis or positive tuberculosis test without a completed course of appropriate treatment or already completed at least 1 month of ongoing appropriate treatment.
e. Evidence of required treatment for cancer (except for treated basal or squamous cell carcinoma of the skin or cervical carcinoma in situ) within 3 years of Visit 1.
5. Any of the following values for laboratory tests at Screening:
a. A positive pregnancy test in WOCBP (also at Visit 1).
b. Hemoglobin < 9 g/dL in males and < 8 gm/dL in females.
c. Neutrophils < 1.0 × 1000000000/L.
d. Platelets < 75 × 1000000000/L.
e. Creatinine clearance < 50 mL/min per the Modification of Diet in Renal Disease (MDRD) Study equation.
f. Aspartate aminotransferase or alanine aminotransferase > 2.0 × upper limit of normal.
6. Any investigational agent within 30 days or 5 therapeutic half-lives of that agent whichever is longer, before Visit 1.
7. Significant diseases or conditions other than SSc or concurrent medical therapies at Screening or Visit 1, including a history of non-compliance with medical treatments, that may put the subject at greater safety risk, influence response to study product, or interfere with study assessments.

1. ES inestable o ES con afectación orgánica terminal en la selección o la visita 1; tales como:
a. Estar incluido en una lista de trasplantes de órganos o haber recibido un trasplante de órganos
b. Crisis renal en el año anterior
c. Enfermedad pulmonar que precisa tratamiento constante con oxígeno. Esto excluye el oxígeno utilizado para ayudar a dormir o hacer ejercicio.
d. Hipertensión pulmonar que precisa tratamiento constante con oxígeno. Esto excluye el oxígeno utilizado para ayudar a dormir o hacer ejercicio.
e. Malabsorción o dismotilidad gastrointestinal que precisa nutrición parenteral total u hospitalización dentro de los 6 meses anteriores a la Visita 1.
2. Ciertas medicaciones en la Visita de selección o Visita 1, incluyendo:
a. Tratamiento con cualquier prednisona oral> 10 mg por día o equivalente dentro de los 28 días previos a la Visita 1. No se permite el tratamiento con corticosteroides intravenosos dentro de los 28 días previos a la Visita 1, y se permite el tratamiento con corticosteroides intraarticulares 28 días antes de la Visita 1.
b. Nueva dosis o aumento de ésta de cualquier medicamento inmunosupresor no corticosteroideo dentro de las 8 semanas previas a la Selección.
c. Tratamiento con ciclofosfamida dentro de los 3 meses anteriores a la Visita 1.
3. Pacientes con enfermedades similares a ES relacionadas a exposiciones o ingestiones.
4. Enfermedades o afecciones significativas distintas de la ES que puedan influir en la respuesta al producto del estudio o la seguridad, tales como:
a. Una nueva infección bacteriana o vírica que se trató con antibióticos orales o intravenosos o tratamientos antivirales dentro de los 28 días anteriores a la Visita 1. Esto no incluye tratamientos antibióticos o antivirales profilácticos.
b. Infección aguda o crónica por hepatitis B o C.
c. Infección por el virus de la inmunodeficiencia humana (VIH).
d. Historial de tuberculosis activa o prueba de tuberculosis positiva sin un curso completo de tratamiento apropiado o ya completado de al menos 1 mes de tratamiento apropiado continuo.
e. Evidencia del tratamiento requerido para el cáncer (excepto el carcinoma basocelular o de células escamosas tratado o el carcinoma cervical in situ) dentro de los 3 años posteriores a la visita 1.
5. Cualquiera de los siguientes valores de las pruebas analíticas en la selección:
a. Un resultado positivo en la prueba de embarazo en las mujeres en edad fértil (también en la Visita 1)
b. Hemoglobina < 9 g/dl para los varones y < 8 g/dl para las mujeres
c. Neutrófilos < 1.0 × 1000000000/L.
d. Plaquetas < 75 × 1000000000/L.
e. Aclaramiento de creatinina < 50 ml/min de acuerdo con la ecuación del estudio Modificación de la dieta en la enfermedad renal(MDRD, Modification of Diet in Renal Disease)
f. Aspartato aminotransferasa o alanina aminotransferasa > 2,0 × límite superior de la normalidad.
6. Cualquier agente en investigación destro de los 30 dias o 5 vidas medias terapéuticas de ese agente, el que sea mayor, antes de la Visita 1.
7. enfermedades significativas o afecciones distintas al ES o tratamiento médico concurrente en la selección o la visita 1, incluidos los antecedentes de incumplimiento de tratamientos médicos, que pudiera implicar un aumento del riesgo para la seguridad del sujeto, influir en la respuesta al producto del estudio o interferir en las evaluaciones del estudio.

E.5 End points

E.5.1

Primary end point(s)

- Efficacy: Modified Rodnan Skin Score (mRSS) (lenabasum 20 mg BID)
- Safety: Treatment Emergent Adverse Events (TEAE) from Day 1

- Eficacia: Puntuación en la escala cutánea de Rodnan modificada (mRSS) (lenabasum 20 mg 2vd)
-Seguridad: Tratamiento de Acontecimientos adversos emergentes (TEAE) desde el día 1

E.5.1.1

Timepoint(s) of evaluation of this end point

at Week 52

En la Semana 52

E.5.2

Secondary end point(s)

Efficacy:
- Health Assessment Questionanaire-Disability Index (HAQ-DI) score (lenabasum 20 mg BID and 5 mg BID)
- American College of Rheumatology (ACR) Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) score (lenabasum 20 mg BID and 5 mg BID)
- mRSS (lenabasum 5 mg BID)
- Forced Vital Capacity (FVC) % predicted (lenabasum 20 mg BID and 5 mg BID)
Safety:
- Tolerability (percentage of subjects discontinuing study treatment due to a TEAE probably or definitely related to study product) of lenabasum treatment and placebo treatment
- Vital signs (systolic and diastolic blood pressure, pulse rate, respiratory rate, body temperature, and weight) recorded at each visit
- Laboratory safety tests obtained at each visit
- Complete blood count with cell differential and platelets
- Metabolic panel that includes renal function, electrolytes, and liver function tests
- Urine dipstick testing for blood, albumin/protein, and glucose
- Physical examinations at Day 1, Week 26, and Week 52
- 12-lead ECGs at Day 1, Week 26, and Week 52

Eficacia:
-Puntuación del Health Assessment Questionanaire-Disability Index (HAQ-DI) (lenabasum 20 mg 2vd y 5 mg 2vd)
-Índice de respuesta combinada del American College of Rheumatology (ACR) en la puntuación de esclerosis sistémica cutánea difusa (CRISS) (lenabasum 20 mg 2vd y 5 mg 2vd)
-mRSS (lenabasum 5 mg 2vd)
-Porcentaje del valor teórico de CVF (lenabasum 20 mg 2vd y 5 mg 2vd)
Seguridad:
-Tolerabilidad (porcentaje de sujetos que suspenden el tratamiento del estudio debido a un AAST probablemente o indudablemente relacionado con el producto del estudio) del tratamiento con lenabasum y del tratamiento con placebo
-Las constantes vitales (presión arterial sistólica y diastólica, frecuencia cardíaca, frecuencia respiratoria, temperatura corporal y peso) registradas en cada visita
-Pruebas analíticas de seguridad obtenidas en cada visita
-Hemograma completo con fórmula leucocitaria y recuento de plaquetas
-Pruebas metabólicas que incluyen función renal, electrolitos y pruebas de la función hepática
-Análisis de orina con tira reactiva para la detección de sangre, albúmina/proteínas y glucosa
-Exploraciones físicas el día 1, la semana 26 y la semana 52
-ECG de 12 derivaciones el día 1, la semana 26 y la semana 52.

E.5.2.1

Timepoint(s) of evaluation of this end point

at Week 52

En la Semana 52

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Australia

Canada

France

Germany

Israel

Italy

Japan

Korea, Republic of

Netherlands

Poland

Spain

Sweden

Switzerland

United States

E.8.7

Trial has a data monitoring committee

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.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

329

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

140

F.4.2.2

In the whole clinical trial

354

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 trial, subjects will continue to receive care for systemic sclerosis from their treating physician. Subjects will remain on their baseline treatment for systemic sclerosis during the trial to reduce the risk of disease flare where study product is discontinued. It is the intent of the Sponsor to offer participation in a separate open-label trial with lenabasum for subjects who complete this trial through to visit 11 (Day 365/Week 52).

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2018-04-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-04-11

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2020-09-23

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