Trial Outcomes & Findings for A Safety and Efficacy Study of JNJ-42165279 in Participants With Social Anxiety Disorder (NCT NCT02432703)

NCT ID: NCT02432703

Last Updated: 2025-04-29

Results Overview

The LSAS is a 24-item, semi-structured interview on the severity of Social Anxiety Disorder. The LSAS separately assesses fear and avoidance of 24 social situations. The scale is divided into 2 subscales, 13 situations concerning performance anxiety, and 11 situations pertaining to social situations. The 24 items are first rated on a Likert Scale from 0 to 3 on fear felt during the situations (0=none, 1=mild, 2=moderate, 3= severe), and then the same items are rated regarding avoidance of the situation (0=never, 1=occasionally, 2=often, 3=usually) with higher scores indicating greater social anxiety. The LSAS fear/anxiety and avoidance subscale was calculated by summing the 24 fear/anxiety and avoidance item scores of the LSAS, and ranges from 0 to 72. Combining the total scores for the Fear and Avoidance sections provides an overall score with a maximum of 144 points and a minimum of 0 points. Higher scores indicated higher probability of social anxiety disorder (SAD).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 150 participants
• Primary outcome timeframe: Baseline and Week 12
• Results posted on: 2025-04-29

Participant Flow

Among 150 participants, one participant was randomized by error. Only 149 participants received treatment and were included in the analysis.

Participant milestones

Measure	Placebo Participants with social anxiety disorder (SAD) received matching placebo orally once daily for 12 weeks.	JNJ-42165279 25 mg Participants with SAD received JNJ-42165279 25 milligrams (mg) orally once daily for 12 weeks.
Overall Study STARTED	75	74
Overall Study COMPLETED	53	56
Overall Study NOT COMPLETED	22	18

Reasons for withdrawal

Measure	Placebo Participants with social anxiety disorder (SAD) received matching placebo orally once daily for 12 weeks.	JNJ-42165279 25 mg Participants with SAD received JNJ-42165279 25 milligrams (mg) orally once daily for 12 weeks.
Overall Study Adverse Event	1	4
Overall Study Lack of Efficacy	1	0
Overall Study Lost to Follow-up	5	3
Overall Study Withdrawal by Subject	9	6
Overall Study Other	6	5

Baseline Characteristics

A Safety and Efficacy Study of JNJ-42165279 in Participants With Social Anxiety Disorder

Baseline characteristics by cohort

Measure	Placebo n=75 Participants Participants with social anxiety disorder (SAD) received matching placebo orally once daily for 12 weeks.	JNJ-42165279 25 mg n=74 Participants Participants with SAD received JNJ-42165279 25 milligrams (mg) orally once daily for 12 weeks.	Total n=149 Participants Total of all reporting groups
Age, Continuous	37.4 years STANDARD_DEVIATION 13.65 • n=5 Participants	38.3 years STANDARD_DEVIATION 12.53 • n=7 Participants	37.8 years STANDARD_DEVIATION 13.07 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	26 Participants n=7 Participants	52 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants	48 Participants n=7 Participants	97 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	13 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	66 Participants n=5 Participants	61 Participants n=7 Participants	127 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants	18 Participants n=7 Participants	33 Participants n=5 Participants
Race (NIH/OMB) White	45 Participants n=5 Participants	50 Participants n=7 Participants	95 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment AUSTRALIA	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Region of Enrollment CANADA	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Region of Enrollment UNITED STATES	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: Intent-to-treat (ITT) analysis set included all randomized participants who received at least 1 dose of the study agent (either placebo or JNJ-42165279), and had at least 1 assessment in the double-blind treatment phase on any of the efficacy parameters.

The LSAS is a 24-item, semi-structured interview on the severity of Social Anxiety Disorder. The LSAS separately assesses fear and avoidance of 24 social situations. The scale is divided into 2 subscales, 13 situations concerning performance anxiety, and 11 situations pertaining to social situations. The 24 items are first rated on a Likert Scale from 0 to 3 on fear felt during the situations (0=none, 1=mild, 2=moderate, 3= severe), and then the same items are rated regarding avoidance of the situation (0=never, 1=occasionally, 2=often, 3=usually) with higher scores indicating greater social anxiety. The LSAS fear/anxiety and avoidance subscale was calculated by summing the 24 fear/anxiety and avoidance item scores of the LSAS, and ranges from 0 to 72. Combining the total scores for the Fear and Avoidance sections provides an overall score with a maximum of 144 points and a minimum of 0 points. Higher scores indicated higher probability of social anxiety disorder (SAD).

Outcome measures

Measure	Placebo n=68 Participants Participants with social anxiety disorder (SAD) received matching placebo orally once daily for 12 weeks.	JNJ-42165279 25 mg n=66 Participants Participants with SAD received JNJ-42165279 25 milligrams (mg) orally once daily for 12 weeks.
Change From Baseline in Liebowitz Social Anxiety Scale (LSAS) Total Score	-22.4 units on a scale Standard Deviation 23.57	-29.4 units on a scale Standard Deviation 27.47

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: ITT analysis set included all randomized participants who received at least 1 dose of the study agent (either placebo or JNJ-42165279), and had at least 1 assessment in the double-blind treatment phase on any of the efficacy parameters.

The LSAS is a 24-item, semi-structured interview on the severity of Social Anxiety Disorder. The LSAS separately assesses fear and avoidance of 24 social situations. The scale is divided into 2 subscales, 13 situations concerning performance anxiety, and 11 situations pertaining to social situations. The 24 items are first rated on a Likert Scale from 0 to 3 on fear felt during the situations (0=none, 1=mild, 2=moderate, 3= severe), and then the same items are rated regarding avoidance of the situation (0=never, 1=occasionally, 2=often, 3=usually). Combining the total scores for the Fear and Avoidance sections provides an overall score with a maximum of 144 points and a minimum of 0 points. Higher scores indicated higher probability of SAD. The LSAS fear/anxiety and avoidance subscale was calculated by summing the 24 fear/anxiety and avoidance item scores of the LSAS, and ranges from 0 to 72.

Outcome measures

Measure	Placebo n=68 Participants Participants with social anxiety disorder (SAD) received matching placebo orally once daily for 12 weeks.	JNJ-42165279 25 mg n=66 Participants Participants with SAD received JNJ-42165279 25 milligrams (mg) orally once daily for 12 weeks.
Change From Baseline in LSAS Fear/Anxiety and Avoidance Subscales Fear/Anxiety	-10.7 units on a scale Standard Deviation 12.31	-14.6 units on a scale Standard Deviation 13.65
Change From Baseline in LSAS Fear/Anxiety and Avoidance Subscales Avoidance	-11.7 units on a scale Standard Deviation 12.16	-14.9 units on a scale Standard Deviation 14.45

SECONDARY outcome

Timeframe: Week 12

Population: ITT analysis set included all randomized participants who received at least 1 dose of the study agent (either placebo or JNJ-42165279), and had at least 1 assessment in the double-blind treatment phase on any of the efficacy parameters.

Responders are participants with >= 50% improvement from baseline. The LSAS scale consists of 24 items which are divided into 2 subscales that address social interactional (11 items) and performance (13 items) situations. The 24 items are first rated on a Likert Scale from 0 to 3 on fear felt during the situations (0=none, 1=mild, 2=moderate, 3= severe), and then the same items are rated regarding avoidance of the situation (0=never, 1=occasionally, 2=often, 3=usually) with higher scores indicating greater social anxiety. The LSAS fear and avoidance subscale was calculated by summing the 24 fear/anxiety and avoidance item scores of the LSAS, and ranges from 0 to 72. Combining the total scores for the Fear and Avoidance sections provides an overall score with a maximum of 144 points and a minimum of 0 points. Higher scores indicated higher probability of SAD.

Outcome measures

Measure	Placebo n=68 Participants Participants with social anxiety disorder (SAD) received matching placebo orally once daily for 12 weeks.	JNJ-42165279 25 mg n=66 Participants Participants with SAD received JNJ-42165279 25 milligrams (mg) orally once daily for 12 weeks.
Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Improvement From Baseline (Responders) on LSAS Total Score	12.7 percentage of participants	18.6 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: ITT analysis set included all randomized participants who received at least 1 dose of the study agent (either placebo or JNJ-42165279), and had at least 1 assessment in the double-blind treatment phase on any of the efficacy parameters.

Remitters are participants with >= 30% improvement from baseline on LSAS total score. The LSAS scale consists of 24 items which are divided into 2 subscales that address social interactional (11 items) and performance (13 items) situations. The 24 items are first rated on a Likert Scale from 0 to 3 on fear felt during the situations (0=none, 1=mild, 2=moderate, 3= severe), and then the same items are rated regarding avoidance of the situation (0=never, 1=occasionally, 2=often, 3=usually) with higher scores indicating greater social anxiety. The LSAS fear and avoidance subscale was calculated by summing the 24 fear/anxiety and avoidance item scores of the LSAS, and ranges from 0 to 72. Combining the total scores for the Fear and Avoidance sections provides an overall score with a maximum of 144 points and a minimum of 0 points. Higher scores indicated higher probability of SAD.

Outcome measures

Measure	Placebo n=68 Participants Participants with social anxiety disorder (SAD) received matching placebo orally once daily for 12 weeks.	JNJ-42165279 25 mg n=66 Participants Participants with SAD received JNJ-42165279 25 milligrams (mg) orally once daily for 12 weeks.
Percentage of Participants With >=30% Improvement From Baseline (Remitters) on LSAS Total Score	23.6 percentage of participants	42.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: ITT analysis set included all randomized participants who received at least 1 dose of the study agent (either placebo or JNJ-42165279), and had at least 1 assessment in the double-blind treatment phase on any of the efficacy parameters.

The SIGH-A was included to determine the frequency and severity of signs and symptoms of anxiety, including participants with comorbid generalized anxiety disorders (GAD) and major depressive disorder (MDD), and determine both their influence on treatment and their responsiveness to treatment. The SIGH-A scale consists of 14 items with a score of 0 to 4. Higher scores indicated higher severity (0-absent, 1-mild, 2-moderate, 3-severe, 4-incapacitating). The SIGH-A total score was calculated by summing the 14 item scores, and ranges from 0 to 56. Higher scores indicated worse results.

Outcome measures

Measure	Placebo n=68 Participants Participants with social anxiety disorder (SAD) received matching placebo orally once daily for 12 weeks.	JNJ-42165279 25 mg n=66 Participants Participants with SAD received JNJ-42165279 25 milligrams (mg) orally once daily for 12 weeks.
Change From Baseline in Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) Total Score	-3.0 units on a scale Standard Deviation 6.20	-4.2 units on a scale Standard Deviation 5.90

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: ITT analysis set included all randomized participants who received at least 1 dose of the study agent (either placebo or JNJ-42165279), and had at least 1 assessment in the double-blind treatment phase on any of the efficacy parameters.

The HAM-A6 is a 6-item subscale derived from the original Hamilton Anxiety scale (HAM-A). It comprises of five psychic anxiety symptoms: anxious mood, psychic tension, fears, intellectual disturbances, and anxious behavior observed at the interview, as well as one somatic item, muscular tension. Each of the 6 items is rated by the clinician on a 5-point scale ranging from 0 (not present) to 4 (maximum degree). The HAM-A6 score was calculated by summing the 6 item scores, and ranges from 0 to 24. Higher scores indicated greater severity of symptoms.

Outcome measures

Measure	Placebo n=68 Participants Participants with social anxiety disorder (SAD) received matching placebo orally once daily for 12 weeks.	JNJ-42165279 25 mg n=66 Participants Participants with SAD received JNJ-42165279 25 milligrams (mg) orally once daily for 12 weeks.
Change From Baseline in Hamilton Anxiety Scale (HAM)-A6 Score	-1.9 units on a scale Standard Deviation 3.32	-2.3 units on a scale Standard Deviation 3.79

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: ITT analysis set included all randomized participants who received at least 1 dose of the study agent (either placebo or JNJ-42165279), and had at least 1 assessment in the double-blind treatment phase on any of the efficacy parameters.

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.

Outcome measures

Measure	Placebo n=68 Participants Participants with social anxiety disorder (SAD) received matching placebo orally once daily for 12 weeks.	JNJ-42165279 25 mg n=66 Participants Participants with SAD received JNJ-42165279 25 milligrams (mg) orally once daily for 12 weeks.
Change From Baseline in Hamilton Depression Rating Scale (HDRS)-17 Total Score	-0.9 units on a scale Standard Deviation 4.71	-1.8 units on a scale Standard Deviation 3.99

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: ITT analysis set included all randomized participants who received at least 1 dose of the study agent (either placebo or JNJ-42165279), and had at least 1 assessment in the double-blind treatment phase on any of the efficacy parameters.

The HDRS17 anxiety/somatization factor derived from Cleary and Guy's factor analysis of the HDRS17 scale, includes six items from the original 17-item version: the items for psychic anxiety, somatic anxiety, gastrointestinal somatic symptoms, general somatic symptoms, hypochondriasis, and insight. Each of these 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). HDRS17 anxiety/somatization factor total score was calculated as the sum of the 6 item scores ranging from 0 to 18. Higher scores indicated greater severity of symptoms.

Outcome measures

Measure	Placebo n=68 Participants Participants with social anxiety disorder (SAD) received matching placebo orally once daily for 12 weeks.	JNJ-42165279 25 mg n=66 Participants Participants with SAD received JNJ-42165279 25 milligrams (mg) orally once daily for 12 weeks.
Change From Baseline in HDRS17 Anxiety/Somatization Factor Total Score	-0.4 units on a scale Standard Deviation 2.25	-0.9 units on a scale Standard Deviation 2.05

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: ITT analysis set included all randomized participants who received at least 1 dose of the study agent (either placebo or JNJ-42165279), and had at least 1 assessment in the double-blind treatment phase on any of the efficacy parameters.

A 6-item subscale from the HDRS17 (HAM-D6) was analyzed as it had been shown to be a uni-dimensional scale that provided information to core depressive symptoms and was sensitive to treatment response. The six items were: depressed mood, guilt feelings, work and interests, psychomotor retardation, psychic anxiety, and general somatics (tiredness and pains). Each of these 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). General somatics is scored 0 to 2 and all others are scored 0 to 4. The HAM-D6 total score was calculated by summing the 6 items scores, and ranges from 0 to 22. Higher scores indicated greater severity of core symptoms.

Outcome measures

Measure	Placebo n=68 Participants Participants with social anxiety disorder (SAD) received matching placebo orally once daily for 12 weeks.	JNJ-42165279 25 mg n=66 Participants Participants with SAD received JNJ-42165279 25 milligrams (mg) orally once daily for 12 weeks.
Change From Baseline in HAM-D6 Total Score	-0.7 units on a scale Standard Deviation 2.89	-1.0 units on a scale Standard Deviation 2.56

SECONDARY outcome

Timeframe: Week 12

Population: All randomized participants who received at least 1 dose of the study agent (either placebo or JNJ-42165279), and had at least 1 assessment in the double-blind treatment phase on any of the efficacy parameters.

The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention. The CGI-I is rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Percentage of participants with change from baseline (very much improved or much improved and Worsening or no change) in CGI-I score were reported.

Outcome measures

Measure	Placebo n=68 Participants Participants with social anxiety disorder (SAD) received matching placebo orally once daily for 12 weeks.	JNJ-42165279 25 mg n=66 Participants Participants with SAD received JNJ-42165279 25 milligrams (mg) orally once daily for 12 weeks.
Percentage of Participants With Change From Baseline in Clinical Global Impression- Improvement (CGI-I) Score Very much improved or much improved	23.6 percentage of participants	44.1 percentage of participants
Percentage of Participants With Change From Baseline in Clinical Global Impression- Improvement (CGI-I) Score Worsening or no change	45.5 percentage of participants	35.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: ITT analysis set included all randomized participants who received at least 1 dose of the study agent (either placebo or JNJ-42165279), and had at least 1 assessment in the double-blind treatment phase on any of the efficacy parameters.

Responders are participants with >= 50% improvement from baseline in SIGH-A total score. The SIGH-A scale consists of 14 items with a score of 0 to 4. Higher scores indicated higher severity (0-absent, 1-mild, 2-moderate, 3 severe, 4-incapacitating). The SIGH-A total score was calculated by summing the 14 item scores, and ranges from 0 to 56. Higher scores indicated worse results.

Outcome measures

Measure	Placebo n=68 Participants Participants with social anxiety disorder (SAD) received matching placebo orally once daily for 12 weeks.	JNJ-42165279 25 mg n=66 Participants Participants with SAD received JNJ-42165279 25 milligrams (mg) orally once daily for 12 weeks.
Percentage of Participants With >=50% Improvement From Baseline (Responders) in SIGH-A Total Score	47.3 percentage of participants	45.6 percentage of participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

JNJ-42165279 25 mg

Serious events: 2 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=75 participants at risk Participants with social anxiety disorder (SAD) received matching placebo orally once daily for 12 weeks.	JNJ-42165279 25 mg n=74 participants at risk Participants with SAD received JNJ-42165279 25 milligrams (mg) orally once daily for 12 weeks.
Immune system disorders Anaphylactic Reaction	0.00% 0/75 • Up to 20 weeks Safety analysis set included all randomized participants who received at least one dose of study medication (either placebo or JNJ-42165279).	1.4% 1/74 • Up to 20 weeks Safety analysis set included all randomized participants who received at least one dose of study medication (either placebo or JNJ-42165279).
Psychiatric disorders Alcohol Use Disorder	0.00% 0/75 • Up to 20 weeks Safety analysis set included all randomized participants who received at least one dose of study medication (either placebo or JNJ-42165279).	1.4% 1/74 • Up to 20 weeks Safety analysis set included all randomized participants who received at least one dose of study medication (either placebo or JNJ-42165279).

Other adverse events

Measure	Placebo n=75 participants at risk Participants with social anxiety disorder (SAD) received matching placebo orally once daily for 12 weeks.	JNJ-42165279 25 mg n=74 participants at risk Participants with SAD received JNJ-42165279 25 milligrams (mg) orally once daily for 12 weeks.
Gastrointestinal disorders Diarrhoea	2.7% 2/75 • Up to 20 weeks Safety analysis set included all randomized participants who received at least one dose of study medication (either placebo or JNJ-42165279).	6.8% 5/74 • Up to 20 weeks Safety analysis set included all randomized participants who received at least one dose of study medication (either placebo or JNJ-42165279).
Gastrointestinal disorders Nausea	5.3% 4/75 • Up to 20 weeks Safety analysis set included all randomized participants who received at least one dose of study medication (either placebo or JNJ-42165279).	0.00% 0/74 • Up to 20 weeks Safety analysis set included all randomized participants who received at least one dose of study medication (either placebo or JNJ-42165279).
General disorders Fatigue	4.0% 3/75 • Up to 20 weeks Safety analysis set included all randomized participants who received at least one dose of study medication (either placebo or JNJ-42165279).	8.1% 6/74 • Up to 20 weeks Safety analysis set included all randomized participants who received at least one dose of study medication (either placebo or JNJ-42165279).
Infections and infestations Nasopharyngitis	8.0% 6/75 • Up to 20 weeks Safety analysis set included all randomized participants who received at least one dose of study medication (either placebo or JNJ-42165279).	5.4% 4/74 • Up to 20 weeks Safety analysis set included all randomized participants who received at least one dose of study medication (either placebo or JNJ-42165279).
Infections and infestations Upper Respiratory Tract Infection	4.0% 3/75 • Up to 20 weeks Safety analysis set included all randomized participants who received at least one dose of study medication (either placebo or JNJ-42165279).	6.8% 5/74 • Up to 20 weeks Safety analysis set included all randomized participants who received at least one dose of study medication (either placebo or JNJ-42165279).
Nervous system disorders Headache	17.3% 13/75 • Up to 20 weeks Safety analysis set included all randomized participants who received at least one dose of study medication (either placebo or JNJ-42165279).	20.3% 15/74 • Up to 20 weeks Safety analysis set included all randomized participants who received at least one dose of study medication (either placebo or JNJ-42165279).
Psychiatric disorders Insomnia	8.0% 6/75 • Up to 20 weeks Safety analysis set included all randomized participants who received at least one dose of study medication (either placebo or JNJ-42165279).	1.4% 1/74 • Up to 20 weeks Safety analysis set included all randomized participants who received at least one dose of study medication (either placebo or JNJ-42165279).

Additional Information

Senior Director

Janssen Research & Development, LLC

Phone: 844-434-4210

Email: ClinicalTrialDisclosure@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation.
• Publication restrictions are in place

Restriction type: OTHER