A study to test different doses of BI 1569912 in people with depression who take anti-depressive medicine

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Boehringer Ingelheim International GmbH

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Behavior and Behavior Mechanisms [F01]

Trial duration

31 Jul 2024 → 11 Mar 2025

Decision date (initial)

2024-07-02

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Boehringer Ingelheim International GmbH

External identifiers

EU CT number

2023-507942-10-00

WHO UTN

U1111-1297-3126

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Efficacy, Safety, Dose response

The primary trial objectives are to demonstrate a [...], to evaluate the dose response relationship, and to assess the quantitative treatment effect size.

Conditions and MedDRA coding

Major depressive disorder

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Male and female participants, 18 to 65 years of age, both inclusively at the time of consent.
2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
3. Women of childbearing potential (WOCBP) must be ready and able to use a highly effective method of birth control per ICH M3 (R2) that results in a low failure rate of less than 1% per year when used consistently and correctly plus one additional barrier method. A list of contraception methods meeting these criteria and instructions on the duration of use is provided in the participant information and in the study protocol.
4. Established diagnosis of MDD, single episode or recurrent, as confirmed at the time of screening by the MINI with a duration of current depressive episode ≥8 weeks at the time of screening visit.
5. Hamilton Depression Rating Scale-17 (HDRS-17) – Severity scale score >17.
6. A documented ongoing monotherapy treatment of ≥6 weeks at the randomisation visit, with an SSRI or SNRI specified in the ISF at adequate dose (at least minimum effective dose as per prescribing information). - The participant must adhere to the screening visit dose of the background SSRI/SNRI until the end of the trial (EoS Visit). Participants should be on a stable dose for at least 4 weeks prior to randomisation. - Participants, who, in addition to their monotherapy with an SSRI/SNRI, are taking additional low dose antidepressant medications for purposes other than treating depressive symptoms, are not excluded. The dose must be less than the lowest dose indicated for MDD.
7. In the current episode, participants have shown insufficient treatment response defined by less than 50% response to a maximum of 4 antidepressant treatments of adequate dose and treatment duration (according to Summary of Product Characteristics) as evaluated by the ATRQ.
8. Further inclusion criteria apply.

Exclusion criteria 9

1. Per MINI, have ever met diagnostic criteria for schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar disorder, or delusional disorder.
2. Diagnosis with antisocial, paranoid, schizoid or schizotypal personality disorder, or MDD with psychotic features as per DSM-5 criteria, at the time of screening visit. Any other personality disorder at screening visit that significantly affects current psychiatric status and likely to impact trial participation, as per the judgement of investigator.
3. Diagnosis of any other mental disorder that was the primary focus of treatment within 6 months prior to screening (as per clinical discretion of the investigator).
4. History or presence (upon clinical examination) of seizure disorders or an increased risk of seizures (first degree relative with epilepsy), stroke, brain tumour or any other major neurological illness that could impact participation in the trial.
5. A current or recent history of clinically significant suicidal ideation with intent within the past 3 months, corresponding to a score of 4 or 5 for ideation on the C-SSRS or a suicidal attempt within the past year, as indicated by the C-SSRS at screening visit.
6. Participants with a body mass index (weight [kg]/height [m]²) lower than 18 kg/m² or greater than 40 kg/m2 at screening.
7. Diagnosis of a moderate to severe substance related disorder within 6 months prior to screening visit (with exception of caffeine and tobacco).
8. Positive drug screen (amphetamines, opiates, cocaine, barbiturates, phencyclidine) at screening or Visit 1A (if applicable). Participants with positive cannabis and benzodiazepine drug tests can be included if the investigator confirms that there is no active substance related disorder.
9. Further exclusion criteria apply.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from baseline in MADRS total score at Week 6

Secondary endpoints 6

1. Change from baseline in MADRS total score at Day 8
2. Response defined as ≥50% MADRS reduction from baseline at Day 8
3. Response defined as ≥50% MADRS reduction from baseline at Week 6
4. Remission defined as MADRS total score ≤10 at Week 6
5. Change from baseline in Symptoms of Major Depressive Disorder Scale (SMDDS) total score at Day 8
6. Change from baseline in SMDDS total score at Week 4

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Boehringer Ingelheim International GmbH

Sponsor organisation

Boehringer Ingelheim International GmbH

Address

Binger Strasse 173

City

Ingelheim Am Rhein

Postcode

55216

Country

Germany

Scientific contact point

Organisation

Boehringer Ingelheim International GmbH

Contact name

CT Disclosure & Data Transparency

Public contact point

Organisation

Boehringer Ingelheim International GmbH

Contact name

CT Disclosure & Data Transparency

Third parties 8

Locations

4 EU/EEA countries · 19 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 110 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications