A study to investigate the efficacy of sirukumab in addition to the current antidepressant treatment in adults with depression

• Register: EUCTR
• Last refreshed on: 10 September 2018
• Main ID: EUCTR2014-005206-37-PL
• Date of registration: 12/08/2015
• Prospective Registration: Yes
• Primary sponsor: Janssen-Cilag International N.V.
• Public title: A study to investigate the efficacy of sirukumab in addition to the current antidepressant treatment in adults with depression
• Scientific title: A Double-Blind, Placebo-Controlled, Multicenter Study of Sirukumab as Adjunctive Treatment to a MonoAminergic antidepressant in Adults with Major Depressive Disorder
• Date of first enrolment: 14/09/2015
• Target sample size: 192
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-005206-37
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Canada, Poland, Russian Federation, United Kingdom, United States

Contacts

• Name: Clinical Registry Group
• Affiliation: Janssen Pharmaceutica N.V.

• Name: Clinical Registry Group
• Affiliation: Janssen Pharmaceutica N.V.

Key inclusion & exclusion criteria

Inclusion criteria:
- Participants must have a primary DSM5 diagnosis of MDD
- Must have a HDRS total score greater than or equal to (>=) 18 at screening and predose at Day 1, as recorded by the remote independent rater and must not demonstrate an improvement of > 25 percent (%) on their HDRS total score from the screening to baseline visit
- Must be medically stable on the basis of physical examination, medical history, vital signs, clinical laboratory tests and 12-lead ECG performed at screening. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the subject's source documents and initialed by the
investigator
- Participants with hypothyroidism who are on stable treatment for 3 months prior to screening are required to have thyroid stimulating hormone (TSH) and free thyroxine (FT4) obtained. If the TSH value is
out of range, but FT4 is normal, such cases should be discussed directly with the medical monitor before the subject is enrolled. If the FT4 value is out of range, the participant is not eligible
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 192
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
- Any other current Axis one psychiatric condition, including, but not limited to, MDD with current psychotic features, bipolar disorder (including lifetime diagnosis), obsessivecompulsive disorder, borderline personality disorder, eating disorder (eg, bulimia, anorexia nervosa), or schizophrenia (lifetime). The MINI will be used to screen for comorbid psychiatric diagnoses. As noted above, subjects with a diagnosis of comorbid GAD, PostTraumatic Stress Disorder, Persistent Depressive Disorder, ADHD, Social Anxiety Disorder, Panic Disorder with or without agoraphobia or Nicotine/Caffeine Dependence may be included, if the investigator considers MDD to be the primary diagnosis
- A history of alcohol or substance use disorder (abuse/dependence) within 6 months prior to screening (nicotine and caffeine dependence are not exclusionary)
- A current or recent (within the past year) history of clinically significant suicidal ideation (corresponding to a score of >= 3 for ideation) or any suicidal behavior within the past year, as validated on the CSSRS at screening or baseline. Subjects with a prior suicide attempt of any sort, or history of prior serious suicidal ideation/plan should be carefully screened for current suicidal ideation and only included at the
discretion of the investigator
- More than 3 failed antidepressant treatments (of adequate dose and duration) in the current episode of depression (verified by the MGHATRQ)
- Length of current major depressive episode > 60 months


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Depression
MedDRA version: 19.1 Level: PT Classification code 10012378 Term: Depression System Organ Class: 10037175 - Psychiatric disorders

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Product Name: Sirukumab
Product Code: CNTO136
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Secondary Objective: - To evaluate the overall safety and tolerability of adjunctive sirukumab compared to adjunctive placebo.
- To evaluate the impact of adjunctive sirukumab compared to adjunctive placebo on anhedonia as measured by the change from study baseline to 12-week endpoint on the Snaith Hamilton Pleasure Scale (SHAPS) in subjects with MDD and screening hsCRP = 0.300 mg/dL.
- To evaluate the impact of treatment with adjunctive sirukumab compared to adjunctive placebo on global severity of symptoms of MDD, as measured by the change in the Clinical Global Impression - Severity (CGI-S) scale from study baseline to 12-week endpoint in subjects with MDD and screening hsCRP =0.300 mg/dL.

For an overview of all objectives please refer to the protocol

Timepoint(s) of evaluation of this end point: Baseline upto Week 12

Main Objective: To evaluate the efficacy of sirukumab as adjunctive treatment to antidepressant therapy (monoaminergic antidepressant) where sirukumab (administered as a 50mg subcutaneous (SC) injection at Day 1, Day 28 and Day 56 during the 12- week double-blind treatment period) is compared to adjunctive placebo based on the change from baseline to 12-week endpoint in depressive symptoms as measured by the total score on the Hamilton Depression Rating Scale (HDRS17), in subjects diagnosed with Major Depressive Disorder (MDD) who have had a suboptimal response to the current standard oral antidepressant therapy and have a screening and baseline high sensitivity C-Reactive Protein (hsCRP) =0.300 mg/dL (International System of Units (SI)

Primary end point(s): Change From Baseline in Hamilton Depression Rating Scale (HDRS17)
Total Score at Week 12

Secondary Outcome(s)

Secondary end point(s): 1. Change From Baseline in Snaith Hamilton Pleasure Scale (SHAPS) Total Score at Week 12
2. Change From Baseline in Clinical Global Impression – Severity (CGIS) Total Score at Week 12
3. Change From Baseline in Patient Health Questionnaire (PHQ9) at Week 12
4. Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) at Week 12
5. Number of Participants as Remitters
6. Number of Participants as Responders
7. Number of Participants with Adverse Events (AEs) and Serious AEs
8. The change from baseline to endpoint on the Hamilton Depression Rating Scale (HDRS17) total score

Timepoint(s) of evaluation of this end point: - for nr 1-4 & 6 - Baseline and Week 12
- for nr 5 - Week 12
- for nr 7 - Screening up to End of Followup Phase (approximately up to 32 - 35 weeks)
- for nr 8 - Baseline upto Week 12

Secondary ID(s)

CNTO136MDD2001

Source(s) of Monetary Support

Janssen Research and Development, LLC