An Efficacy and Safety Study of Sirukumab in Participants With Major Depressive Disorder

NCT02473289 | Completed Phase 2 Results DMC

• 3 other identifiers: CR107171CNTO136MDD20012014-005206-37
• Study Type: interventional
• Target: 193
• Locations: 5 countries
• Sites: 46

Brief Summary

The purpose of this study is to evaluate the efficacy of sirukumab as adjunctive treatment to antidepressant therapy (monoaminergic antidepressant) where sirukumab (administered as a 50 milligram (mg) 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 (HDRS), in participants diagnosed with Major Depressive Disorder (MDD) who have had a suboptimal response to the current standard oral antidepressant therapy and have a screening high sensitivity C-Reactive Protein (hsCRP) \>=0.300 milligram per deciliters (mg/dL) (International System of Units (SI) 3.00 mg/L). A cohort of subjects with hsCRP \<0.300 milligram per deciliter will also be enrolled to allow a better understanding of the relationship between CRP and clinical changes.

Conditions

Depressive Disorder, Major

Keywords

Depressive disorder, major; Sirukumab

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Hamilton Depression Rating Scale (HDRS-17) Total Score at Week 12

  The HDRS-17 is a clinician-administered rating scale designed to assess the severity of symptoms in participants diagnosed with depression with a score range of 0 to 52. Each of the 17 items is rated by the clinician on either a 3-point (0 to 2) or a 5-point scale (0 to 4). The point scale used a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A total score (0 to 52) was calculated by adding the scores of all 17 items. For each item as well as the total score, a higher score represents a more severe condition. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.

  Baseline and Week 12

Secondary Outcomes (8)

• Change From Baseline in HDRS-17 Total Score at Weeks 1, 4 and 8

  Baseline, Weeks 1, 4 and 8

• Percentage of Participants With Remission as Assessed by HDRS-17 Total Score at Week 12

  Week 12

• Percentage of Participants With Response as Assessed by HDRS-17 Total Score at Week 12

  Week 12

• Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Score at Weeks 1, 4, 8, 12, 16, and 22

  Baseline and Weeks 1, 4, 8, 12, 16, and 22

• Change From Baseline in Patient Health Questionnaire (PHQ-9) Total Score at Weeks 1, 4, 8, 12, 16, and 22

  Baseline and Weeks 1, 4, 8, 12, 16, and 22

Study Arms (2)

Sirukumab 50 milligram (mg)

EXPERIMENTAL

Participants will receive sirukumab 50 mg as subcutaneous injection on Day 1, 28 and 56.

Drug: Sirukumab 50 mg

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo on Day 1, 28 and 56.

Drug: Placebo

Interventions

Sirukumab 50 mg DRUG

Participants will receive sirukumab 50 mg as subcutaneous injection on Day 1, 28 and 56.

Sirukumab 50 milligram (mg)

Placebo DRUG

Participants will receive matching placebo on Day 1, 28 and 56.

Placebo

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must have a primary DSM-5 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

You may not qualify if:

• Any other current Axis one psychiatric condition, including, but not limited to, MDD with current psychotic features, bipolar disorder (including lifetime diagnosis), obsessive-compulsive 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, Post-Traumatic 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 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 C-SSRS 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 MGH-ATRQ)
• Length of current major depressive episode \> 60 months

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (46)

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Birmingham, Alabama, United States

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Little Rock, Arkansas, United States

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Bellflower, California, United States

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Glendale, California, United States

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Lemon Grove, California, United States

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Orange, California, United States

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Santa Ana, California, United States

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Torrance, California, United States

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Wildomar, California, United States

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Atlanta, Georgia, United States

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Decatur, Georgia, United States

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Chicago, Illinois, United States

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Edgewood, Kentucky, United States

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Baltimore, Maryland, United States

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Grand Rapids, Michigan, United States

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Lebanon, New Hampshire, United States

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Brooklyn, New York, United States

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New York, New York, United States

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Staten Island, New York, United States

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Columbus, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Houston, Texas, United States

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Plano, Texas, United States

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Salt Lake City, Utah, United States

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Edmonton, Alberta, Canada

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Chatham, Ontario, Canada

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Hamilton, Ontario, Canada

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Toronto, Ontario, Canada

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Bełchatów, Poland

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Bydgoszcz, Poland

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Chełmno, Poland

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Gorlice, Poland

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Lublin, Poland

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Karelia, Russia

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Moscow, Russia

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Nizny Novgorod, Russia

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Rostov-on-Don, Russia

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Saint Petersburg, Russia

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Saratov, Russia

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Saratov Region, Russia

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Tomsk, Russia

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Yaroslavl, Russia

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Edinburgh, United Kingdom

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Glasgow, United Kingdom

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Oxford, United Kingdom

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Redruth, United Kingdom

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MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

sirukumab

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: ASSOCIATE DIRECTOR
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2015
• First Posted: June 16, 2015
• Study Start: July 23, 2015
• Primary Completion: May 22, 2018
• Study Completion: May 22, 2018
• Last Updated: April 29, 2025
• Results First Posted: June 11, 2019

Record last verified: 2025-04

Locations

CA (4); RU (9); PL (5); GB (4); US (24)