Klinikai vizsgálatok Nct

Summary
EudraCT Number:2022-000430-42
Sponsor's Protocol Code Number:67953964MDD3003_VENTURA-LT
National Competent Authority:Poland - Office for Medicinal Products
Clinical Trial Type:EEA CTA
Trial Status:Ongoing
Date on which this record was first entered in the EudraCT database:2023-01-03
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 ConcernedPoland - Office for Medicinal Products
A.2EudraCT number2022-000430-42
A.3Full title of the trial
An Open-label, Long-term, Safety and Efficacy Study of Aticaprant as Adjunctive Therapy in Adult and Elderly Participants With Major Depressive Disorder (MDD)
A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
a study to evaluate if aticaprant added to a current antidepressant and given up to one year is safe and would help improve depression.
A.3.2Name or abbreviated title of the trial where available
Ventura- LT
A.4.1Sponsor's protocol code number67953964MDD3003_VENTURA-LT
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, LLC
B.4.2CountryUnited States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisationJanssen-Cilag International NV
B.5.2Functional name of contact pointClinical Registry Group
B.5.3 Address:
B.5.3.1Street Address Janssen Biologics BV- Clinical registry group- Archimedesweg 29
B.5.3.2Town/ cityLeiden
B.5.3.3Post code2333CM
B.5.3.4CountryNetherlands
B.5.6E-mailClinicalTrialsEU@its.jnj.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 nameAticaprant
D.3.2Product code JNJ-67953964
D.3.4Pharmaceutical form Tablet
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 INNAticaprant
D.3.9.2Current sponsor codeJNJ-67953964
D.3.9.4EV Substance CodeSUB198023
D.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number10
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
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 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 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
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Major Depressive Disorder (MDD)
E.1.1.1Medical condition in easily understood language
Depression
E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 21.1
E.1.2Level LLT
E.1.2Classification code 10025453
E.1.2Term Major depressive disorder NOS
E.1.2System Organ Class 100000004873
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
To assess the long-term safety and tolerability of aticaprant
E.2.2Secondary objectives of the trial
To assess the long-term efficacy of aticaprant
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
Transferred patients:
- Participants must have completed the Double Blind Treatment Phase of
Study 67953964MDD3001 or Study 67953964MDD3002 study.
- Participant must be medically stable on the basis of physical
examination, medical history, vital signs (including blood pressure), and
12-lead ECG performed at baseline and prior to Open Label treatment
initiation.
Direct entry patients:
- Male or female, aged 18 to 74 years of age, inclusive.
- Be medically stable on the basis of physical examination, medical
history, vital signs, and 12-lead ECG performed at screening and baseline
- Be medically stable on the basis of clinical laboratory tests performed
at screening
- Meet DSM-5 diagnostic criteria for recurrent or single episode MDD,
without psychotic features. Participants 65 years of age or older must
have had the first onset of depression prior to 55 years of age.
- Have had an inadequate response to at least 1 oral antidepressant
treatment, administered at an adequate dose and duration in the current
episode of depression.
- Is receiving and tolerating well a SSRI/SNRI for depressive symptoms
at screening, at a stable dose for at least 6 weeks
- Have a HDRS-17 total score of 20 or higher at the first and second
screening interviews and must not demonstrate a clinically significant
improvement between the first and the second independent HDRS-17 assessments
Please refer to study protocol for full list of inclusion criteria.
E.4Principal exclusion criteria
Transferred-entry participants:
- Participant has been non-compliant with the study intervention
administration in the Double Blind (DB) Treatment Phase in either of
Studies 67953964MDD3001 or 67953964MDD3002
- The evaluation of the benefit versus risk of continued aticaprant
treatment is not favorable for the participant in the opinion of the
investigator.
- Participant is reporting suicidal ideation with intent to act or suicidal
behavior at baseline.
- Participant has taken any prohibited therapies that would not permit
dosing on Day 1, as noted in the pre-study and concomitant therapy
section.
- Participant has any condition or situation/circumstance for which, in
the opinion of the investigator, participation would not be in the best
interest of the participant (eg, compromise the well-being) or that could
prevent, limit, or confound the protocol-specified assessments.
Direct-entry participants:
- Have had in the current depressive episode, no response (treatment
failure) to 5 or more antidepressant treatments including the current
SSRI/SNRI
- Has a history or evidence of clinically meaningful noncompliance with
current antidepressant therapy.
- Has a history of moderate-to-severe substance use disorder including
alcohol use disorder according to DSM-5 criteria within 6 months before
screening
- Has had in the current episode an inadequate response to adequate
course of intravenous or intranasal ketamine or esketamine,
electroconvulsive therapy (i.e, at least 7 treatments), vagal nerve
stimulation, or a deep brain stimulation device
- Has a current homicidal ideation/intent, per the investigator's clinical
judgment, or has suicidal ideation with some intent to act within 3
months prior to the start of the screening phase
Please refer to study protocol for full list of exclusion criteria.
E.5 End points
E.5.1Primary end point(s)
* AEs including AEs of special interest (AESI)
* Change from baseline in vital signs
* Weight/body mass index (BMI)
* Suicidality assessment using the Columbia Suicidality Severity Rating
Scale (C-SSRS)
* Laboratory parameters
* 12-lead ECG
* Assessment of withdrawal symptoms using the Physician Withdrawal
Checklist, 20-item (PWC-20).
* Proportion of participants with clinically relevant sexual dysfunction
over time in the Arizona Sexual Experiences Scale (ASEX) score.
E.5.1.1Timepoint(s) of evaluation of this end point
Throughout the study
E.5.2Secondary end point(s)
Depressive Symptoms, anhedonia symptoms, severity of depressive illness
E.5.2.1Timepoint(s) of evaluation of this end point
starting at baseline, ending at follow-up
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 Yes
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 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 No
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 concerned13
E.8.5The trial involves multiple Member States Yes
E.8.5.1Number of sites anticipated in the EEA101
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
Taiwan
Australia
Belgium
Brazil
Bulgaria
Canada
China
Czechia
France
Hungary
Italy
Japan
Korea, Republic of
Mexico
Poland
Portugal
Serbia
Slovakia
South Africa
Spain
Sweden
United Kingdom
United States
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 schedule of assessments for the last participant in the study
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 months5
E.8.9.1In the Member State concerned days0
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 days12
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: 672
F.1.3Elderly (>=65 years) Yes
F.1.3.1Number of subjects for this age range: 168
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 state11
F.4.2 For a multinational trial
F.4.2.1In the EEA 348
F.4.2.2In the whole clinical trial 840
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)
There is no provision of aticaprant following the end of open label Treatment Phase. Participants will be instructed that aticaprant will not be made available to them after they have completed the OL Treatment Phase (Week 52). Further clinical/standard of care for the treatment of depression will be arranged by the study investigator and/or the participant's treating physician.
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 Decision2023-04-13
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2022-12-06
P. End of Trial
P.End of Trial StatusOngoing

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