E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10004936 |
E.1.2 | Term | Bipolar depression |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the efficacy of JNJ-55308942 compared to placebo on symptoms of depression in participants with bipolar disorders (BD) in a major depressive episode (MDE) at Week 6. |
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E.2.2 | Secondary objectives of the trial |
Secondary Objectives of Special Interest are: 1. To evaluate the efficacy of JNJ-55308942 compared to placebo on symptoms of anhedonia 2. To evaluate the efficacy of JNJ-55308942 compared to placebo on symptoms of depression in participants with BD who are heterozygous or homozygous for a P2X7 GoF SNP biomarker (genetic subgroup analysis) 3. To evaluate the efficacy of JNJ-55308942 compared to placebo on symptoms of depression in participants with BD type I or BD type II (diagnosis subgroup analysis) 4. To evaluate the efficacy of JNJ-55308942 compared to placebo on symptoms of depression in subgroups of patients with specific biomarker profiles (biomarker subgroup analysis) 5. To evaluate the efficacy of JNJ-55308942 compared to placebo on symptoms of depression in a subgroup of patients with messenger ribonucleic acid (mRNA) transcript levels at baseline that exceed the median level for both P2RX7 and IL-1β |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Each potential participant must satisfy all of the following criteria to be enrolled in the study:
Age 1. Any gender, 18 to 64 years of age, inclusive. Participants should be at least 18 years of age or older as per the legal age of consent in the jurisdiction in which the study is taking place.
Type of Participant and Disease Characteristic 2. Presence of one or two copies of a GoF SNP biomarker in the P2RX7 gene. 3. Have a primary DSM-5 diagnosis of BD (Type I or II) without psychotic features, as confirmed by the MINI. 4. Must be experiencing an MDE 5. 5. If currently unmedicated and not received any mood stabilizers or antipsychotics for four weeks before screening. If currently on a stable monotherapy regimen of one of the following mood stabilizers (lithium, valproate forms [e.g., divalproex sodium], or lamotrigine) or one of the following antipsychotics (lurasidone, cariprazine, quetiapine, lumateperone, or olanzapine) four weeks before screening. If currently on a stable adjuctive regimen of one of the following antipsychotics (lurasidone, quetiapine, lumateperone, or olanzapine) and one of the following mood stabilizers (lithium, valproate forms [e.g., divalproex sodium] may be considered for eligibility based on the approved therapies in each market with an eligibility assessment conducted between the investigator and sponsor. Assessment of the stable adjuctive regimen of an antipsychotic and a mood stablizer will be conducted by the investigator and sponsor's clinical judgement and documented for each patient. This regimen must be in place 4 weeks before screening. 6. Medically stable on the basis of physical examination, medical history, and vital signs performed at screening. 7. Medically stable on the basis of clinical laboratory tests performed at screening.
Please refer to protocol for full inclusion criteria. |
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E.4 | Principal exclusion criteria |
Any potential participant who meets any of the following criteria will be excluded from participating in the study:
Medical Conditions 1. Presence of two copies of a first LoF SNP biomarker, and/or has one or two copies of a second LoF SNP biomarker in the P2RX7 gene. 2. Based on the MINI (with Borderline Personality Disorder module) and clinical discretion, has a current DSM-5 diagnosis of: • borderline personality disorder • antisocial personality disorder • eating disorder • suicide behavior disorder • ≥ 4 episodes of mood disturbances (e.g., mania, hypomania, depressed, dysthymia, or hypomania) within the past 12 months • any psychotic disorder 3. Currently meets the DSM-5 criteria for Manic Episode (ME) on the MINI. 4. A YMRS of >12.
Please refer to protocol for full exclusion criteria. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Secondary endpoints of Special Interest: 1. Change in Dimensional Anhedonia Rating Scale (DARS) total score from baseline 2. Change in MADRS total score from baseline
Other secondary endpoints: 3. Vital signs, clinical labs, AEs, ECG, Young Mania Rating Scale (YMRS) score, Columbia Suicide Severity Rating Scale (C-SSRS) score 4. CGI-S 5. Plasma concentrations of JNJ-55308942 6.Self-rated outcomes 7. Response and remission rates
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1, 2 and 7: At week 6 3. Throughout the study 4 and 5. Day 1 (D1), D8, D15, D29 and D43 6. D1, D8, D15, D22, D29, D36 and D43
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Stratified, multicenter study |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 16 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 18 |
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 | No |
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 |
Ukraine |
Russian Federation |
United States |
Poland |
Spain |
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E.8.7 | Trial 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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 9 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 28 |