Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ended
Participants planned
1,200
Countries
1
Sites
2
Opioid Use Disorder
Assess the clinical outcomes of long-term treatment with SUBLOCADE in participants with a history of having, or who currently have, moderate-to-severe OUD (US and Canada) or opioid dependence (Australia and EU)
Key facts
- Sponsor
- Indivior Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Trial duration
- 22 Apr 2024 → 1 Sep 2025
- Decision date (initial)
- 2024-02-15
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Indivior Inc,
External identifiers
- EU CT number
- 2023-505098-34-00
- ClinicalTrials.gov
- NCT05860959
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
Assess the clinical outcomes of long-term treatment with SUBLOCADE in participants with a history of having, or who currently have, moderate-to-severe OUD (US and Canada) or opioid dependence (Australia and EU)
Conditions and MedDRA coding
Opioid Use Disorder
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10079385 | Opioid use disorder | 10037175 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Is an adult ≥ 18 years of age who has signed the ICF
- Plans to receive additional SUBLOCADE injections and has initiated treatment for OUD/opioid dependence with SUBLOCADE within the last 3 months prior to Baseline Visit OR has completed an Indivior SUBLOCADE study (eg, INDV-6000-401, INDV-6000-405) and has received the last dose of SUBLOCADE on that study within 3 months prior to Baseline Visit
Exclusion criteria 2
- Patient participating in any clinical trial requiring medical intervention
- Patient currently using opioids to treat a diagnosis other than OUD/opioid dependence
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Participants achieving DSM-5 remission, early or sustained, (yes/no) while on initial SUBLOCADE treatment by 6 months and 1, 1.5, 2, 2.5, and 3 years from study Baseline
Secondary endpoints 9
- Participants with “no symptoms”or improving by ≥1 DSM-5 severity classification within the last 3 months (moderate to mild, or severe to mild or moderate) relative to study Baseline (yes/no) at Month 6 and Years 1, 2, and 3 (Key Secondary Endpoint)
- Among those starting SUBLOCADE within 3 months of study Baseline, time to achieve early remission for the first time while on initial SUBLOCADE treatment
- Participants achieving DSM-5 sustained remission (yes/no) by 1, 1.5, 2, 2.5, and 3 years while on initial SUBLOCADE treatment
- Time to achieve sustained remission for the first time while on initial SUBLOCADE treatment
- Time to discontinuing initial SUBLOCADE treatment and the corresponding reasons for discontinuation, eg, resolution of OUD (Opioid Use Disorder) symptoms, safety concerns, treatment failure, or seeking alternative MOUD (Moderate Opioid Use Disorder) treatment
- Participants switching from initial SUBLOCADE treatment to another MOUD (yes/no), and the corresponding reasons, eg, safety concerns, treatment failure, seeking alternative MOUD treatment
- The overall treatment duration for participants who stop initial SUBLOCADE treatment as the result of resolution of OUD symptoms
- Participants with any positive opioid use in the past month (yes/no) at Month 6 and Years 1, 2, and 3 while on initial SUBLOCADE treatment
- Participants with opioid overdose requiring intervention (yes/no) while on initial SUBLOCADE treatment at least once during the first 6 months, and during Years 1, 2, and 3
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Subutex 100 mg injektionsvätska, depotlösning
PRD8022787 · Product
- Active substance
- Buprenorphine
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 3.33 mg milligram(s)
- Max total dose
- 100 mg milligram(s)
- Max treatment duration
- 1 Month(s)
- Authorisation status
- Authorised
- ATC code
- N07BC01 — BUPRENORPHINE
- Marketing authorisation
- 58558
- MA holder
- INDIVIOR EUROPE LIMITED
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Subutex 300 mg injektionsvätska, depotlösning
PRD8022790 · Product
- Active substance
- Buprenorphine
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 1 Month(s)
- Authorisation status
- Authorised
- ATC code
- N07BC01 — BUPRENORPHINE
- Marketing authorisation
- 58559
- MA holder
- INDIVIOR EUROPE LIMITED
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Indivior Inc.
- Sponsor organisation
- Indivior Inc.
- Address
- 10710 Midlothian Turnpike Suite 125
- City
- North Chesterfield
- Postcode
- 23235-4776
- Country
- United States
Scientific contact point
- Organisation
- Indivior Inc.
- Contact name
- Lori Hannan, Clinical Project Manager
Public contact point
- Organisation
- Indivior Inc.
- Contact name
- Lori Hannan, Clinical Project Manager
Third parties 2
| Organisation | City, country | Duties |
|---|---|---|
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Other, E-data capture |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring, Code 13, Other, Code 2, Code 5, Data management, E-data capture |
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ended | 50 | 2 |
| Rest of world
Australia, Canada, United States
|
— | 1,150 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Sweden | 2024-04-22 | 2024-06-27 | 2025-08-01 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 21 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D_INDV-6000-406_HCRU_Questionnaire_SE_SE_V1_29Nov2022 | N/A |
| Protocol (for publication) | D_INDV-6000-406_Health_Questionnaire_SE_SE_V1 | 1 |
| Protocol (for publication) | D_INDV-6000-406_MedicalSatisfaction_SE_SE_V1_20Feb2023 | N/A |
| Protocol (for publication) | D_INDV-6000-406_Motivation to Quit Ladder_SE_SE_V1_29Nov2022 | N/A |
| Protocol (for publication) | D_INDV-6000-406_Opoid Craving Rating Scale_SE_SE_V1_29Nov2022 | N/A |
| Protocol (for publication) | D_INDV-6000-406_PEG Scale_SE_SE_V1_29Mar2023 | N/A |
| Protocol (for publication) | D_INDV-6000-406_PROMIS Sleep Disturbance Form_SE_SE_V1_25May21 | 1 |
| Protocol (for publication) | D_INDV-6000-406_Social Demographics_SE_SE_V1_20Feb2023 | N/A |
| Protocol (for publication) | D_INDV-6000-406_SOWS_SE_SE_V1_10Aug2023 | N/A |
| Protocol (for publication) | D1_INDV-6000-406_Protocol_SE_EN_Amend1_ForPub_tracked | Amend 1 |
| Protocol (for publication) | D1_INDV-6000-406_Protocol_SE_EN_ForPub | Amend 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement | 3.0 |
| Recruitment arrangements (for publication) | K1_Recrutiment Arrangement_tracked changes | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adult_redacted | 3.0SWE1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adult_tracked changes_redacted | 3.0SWE1.0 |
| Subject information and informed consent form (for publication) | L2_eConsent Patient Materials_Swedish | N/A |
| Subject information and informed consent form (for publication) | L2_Patient Cloud App_Standard Screens_ Sweden | 2.4 |
| Subject information and informed consent form (for publication) | L2_Storyboard | 5.0 |
| Subject information and informed consent form (for publication) | L2_Video Script_Translation of phrases into Swedish | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | G2_INDV_ 6000-406_SmPC_Subutex Prolonged-release_SE_16Jan2025 | 2 |
| Synopsis of the protocol (for publication) | D1-INDV-6000-406_Synopsis of the Protocol_SE_Swedish_29Mar2023 | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-07 | Sweden | Acceptable 2024-02-06
|
2024-02-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-11 | Sweden | Acceptable | 2025-02-07 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-12 | Sweden | Acceptable 2025-04-24
|
2025-04-29 |