NCT03664232 (Envision) is a Phase 2 clinical trial of JNJ-42165279 in Autism Spectrum Disorder, sponsored by Janssen Research & Development, LLC.

Who is sponsoring NCT03664232?

NCT03664232 is sponsored by Janssen Research & Development, LLC.

What drugs are being tested in NCT03664232?

Interventions in NCT03664232: JNJ-42165279, Placebo.

What condition does NCT03664232 study?

NCT03664232 studies Autism Spectrum Disorder.

Is NCT03664232 still recruiting?

NCT03664232 is currently completed. Last updated 23 April 2025.

Are results published for NCT03664232?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-04-23 · How we verify

NCT03664232: Envision

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Investigate the Efficacy, Safety, and Tolerability of JNJ-42165279 in Adolescent and Adult Participants With Autism Spectrum Disorder

Completed Phase 2 Results posted Last updated 23 April 2025

What this trial tests

Phase 2 trial testing JNJ-42165279 in Autism Spectrum Disorder in 78 participants. Completed in 28 October 2022.

Timeline

7 November 2018

Primary endpoint
17 October 2022

28 October 2022

Quick facts

Lead sponsor	Janssen Research & Development, LLC
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	78
Start date	7 November 2018
Primary completion	17 October 2022
Estimated completion	28 October 2022
Sites	9 locations across United States

Drugs / interventions tested

JNJ-42165279 — full drug profile →
Placebo

Conditions studied

Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →

Sponsor

Janssen Research & Development, LLC — full company profile →

Who can join

Adults 13 to 35, any sex, with Autism Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline to Day 85 in the Autism Behavior Inventory (ABI) Core Domain Score (Social Communication and Restrictive Behaviour) Primary · Baseline (Day 1) to Day 85

ABI:62-item questionnaire to track outcomes in autism spectrum disorder (ASD). Each item was answered on 1 of 2 possible dimensions: quality (how well person carries out particular behavior; 1 to 13 items) or frequency (how often particular behavior occurs; 14 to 62 items). Each item was rated on scale of 0 (never) to 3 (very often) for frequency and 0 (without help) to 3 (not at all) for quality. Higher score=severe symptoms/more frequency. ABI core domain score was from 2 domains: social communication (23 items; 3 sub-domains) and repetitive/restrictive behavior (RRB;15 items; 4 sub-domains)

Group	Value	95% CI
Placebo BID	-0.20	± 0.400
JNJ-42165279 25 mg BID	-0.26	± 0.274

Change From Baseline to Day 85 in the ABI Social Communication Domain Score Primary · Baseline (Day 1) to Day 85

ABI was 62-item questionnaire completed on a web/mobile application or on paper. It tracks outcomes in ASD. Each ABI item was answered on 1 of 2 possible dimensions, quality (how well a person carries out a particular behavior; 1 to 13 items) or frequency (how often a particular behavior occurs; 14 to 62 items). Each item was rated on scale of 0 (never) to 3 (very often) for frequency and 0 (without help) to 3 (not at all) for quality. Higher score indicated severe symptoms/more frequency. The ABI social communication domain score consisted of 23 items; with 3 sub-domains. The domain and sub-d

Group	Value	95% CI
Placebo BID	-0.22	± 0.379
JNJ-42165279 25 mg BID	-0.27	± 0.332

Change From Baseline to Day 85 in the ABI Repetitive/Restrictive Behavior (RRB) Domain Score Primary · Baseline (Day 1) to Day 85

ABI is 62-item questionnaire completed on a web/mobile application or on paper. It tracks outcomes in ASD. Each ABI item was answered on 1 of 2 possible dimensions, quality (how well a person carries out a particular behavior; 1 to 13 items) or frequency (how often a particular behavior occurs; 14 to 62 items). Each item was rated on scale of 0 (never) to 3 (very often) for frequency and 0 (without help) to 3 (not at all) for quality. Higher score indicated severe symptoms/more frequency. The ABI RRB domain score consisted of 15 items; with 3 sub-domains. The domain and sub-domain scores were

Group	Value	95% CI
Placebo BID	-0.17	± 0.525
JNJ-42165279 25 mg BID	-0.23	± 0.299

Change From Baseline to Day 85 in the ABI Mood and Anxiety Domain Score Secondary · Baseline (Day 1) to Day 85

ABI was 62-item questionnaire to track outcomes in ASD. Each ABI item was answered on 1 of 2 possible dimensions, quality (how well a person carries out a particular behavior; 1 to 13 items) or frequency (how often a particular behavior occurs; 14 to 62 items). Each item was rated on scale of 0 (never) to 3 (very often) for frequency and 0 (without help) to 3 (not at all) for quality. Higher score indicated severe symptoms/more frequency. ABI mood and anxiety domain had 9 items with 5 sub-domains. ABI mood and anxiety domain and its sub-domains, scores ranged from 0 to 3 with higher scores ind

Group	Value	95% CI
Placebo QD	-0.30	± 0.408
Placebo BID	-0.23	± 0.622
JNJ-42165279 25 mg QD	-0.19	± 0.551
JNJ-42165279 25 mg BID	-0.26	± 0.552

Change From Baseline to Day 85 in the ABI Challenging Behavior Domain Score Secondary · Baseline (Day 1) to Day 85

ABI was 62-item questionnaire to track outcomes in ASD. Each ABI item was answered on 1 of 2 possible dimensions, quality (how well a person carries out a particular behavior; 1 to 13 items) or frequency (how often a particular behavior occurs; 14 to 62 items). Each item was rated on scale of 0 (never) to 3 (very often) for frequency and 0 (without help) to 3 (not at all) for quality. Higher score indicated severe symptoms/more frequency. ABI challenging behavior domain had 7 items with 4 sub-domains. ABI challenging behavior domain and its sub-domains, scores ranged from 0 to 3 with higher sc

Group	Value	95% CI
Placebo QD	-0.27	± 0.329
Placebo BID	-0.22	± 0.533
JNJ-42165279 25 mg QD	-0.20	± 0.411
JNJ-42165279 25 mg BID	-0.20	± 0.532

Change From Baseline to Day 85 in the ABI Self-Regulation Domain Score Secondary · Baseline (Day 1) to Day 85

ABI was 62-item questionnaire to track outcomes in ASD. Each ABI item was answered on 1 of 2 possible dimensions, quality (how well a person carries out a particular behavior; 1 to 13 items) or frequency (how often a particular behavior occurs; 14 to 62 items). Each item was rated on scale of 0 (never) to 3 (very often) for frequency and 0 (without help) to 3 (not at all) for quality. Higher score indicated severe symptoms/more frequency. ABI self-regulation domain had 8 items with 2 sub-domains. ABI self-regulation domain and its sub-domains, scores ranged from 0 to 3 with higher scores indic

Group	Value	95% CI
Placebo QD	-0.31	± 0.272
Placebo BID	-0.20	± 0.510
JNJ-42165279 25 mg QD	-0.11	± 0.364
JNJ-42165279 25 mg BID	-0.18	± 0.380

Change From Baseline to Day 85 in the Aberrant Behavior Checklist (ABC) Subscales Scores Secondary · Baseline (Day 1) to Day 85

The ABC was 58-item behavior rating scale used to measure behavior problems across 5 subscales: irritability (15 items), lethargy (social withdrawal; 16 items), stereotypic behavior (7 items), hyperactivity/ noncompliance (16 items), and inappropriate speech (4 items). Items were rated on a 4-point scale score ranging from 0 (not at all a problem) to 3 (the problem is severe in degree). The total subscale scores ranged from 0 to 45, 0 to 48, 0 to 21, 0 to 48 and 0 to 12 for irritability, lethargy (social withdrawal), stereotypic behavior, hyperactivity, and inappropriate speech respectively. T

Irritability

Group	Value	95% CI
Placebo QD	-5.86	± 5.398
Placebo BID	-3.80	± 6.408
JNJ-42165279 25 mg QD	-2.71	± 6.291
JNJ-42165279 25 mg BID	-4.18	± 8.940

Lethargy/Social Withdrawal

Group	Value	95% CI
Placebo QD	-6.86	± 5.014
Placebo BID	-3.31	± 7.092
JNJ-42165279 25 mg QD	-2.71	± 4.680
JNJ-42165279 25 mg BID	-5.14	± 7.271

Stereotypic Behavior

Group	Value	95% CI
Placebo QD	-1.86	± 2.340
Placebo BID	-1.19	± 3.359
JNJ-42165279 25 mg QD	-0.14	± 1.676
JNJ-42165279 25 mg BID	-1.68	± 3.128

Hyperactivity/Noncompliance

Group	Value	95% CI
Placebo QD	-6.00	± 3.916
Placebo BID	-4.77	± 7.010
JNJ-42165279 25 mg QD	-2.00	± 6.351
JNJ-42165279 25 mg BID	-4.07	± 6.532

Inappropriate Speech

Group	Value	95% CI
Placebo QD	-1.43	± 2.573
Placebo BID	-0.85	± 1.826
JNJ-42165279 25 mg QD	-0.43	± 0.787
JNJ-42165279 25 mg BID	-0.86	± 2.138

Change From Baseline to Day 71 in the Autism Behavior Inventory-Short Form (ABI-S) Domains Scores Secondary · Baseline (Day 1) to Day 71

The ABI-S was the shorter version of ABI. It consists of 24 items across 5 areas: challenging behavior (3 items), mood and anxiety (5 items), restrictive behaviors (7 items), social communication (6 items), and self-regulation (3 items). Each item was answered on 1 of 2 possible dimensions, quality (how well a person carries out a particular behavior or frequency (how often a particular behavior occurs). Each ABI-S domain score was calculated as the sum of the scores in the ABI-S domain divided by the total number of items in this domain. Each item was rated on scales of 0 (never) to 3 (very o

Challenging behavior

Group	Value	95% CI
Placebo QD	0.07	± 0.548
Placebo BID	-0.17	± 0.618
JNJ-42165279 25 mg QD	-0.33	± 0.707
JNJ-42165279 25 mg BID	-0.32	± 0.477

Mood and anxiety

Group	Value	95% CI
Placebo QD	-0.48	± 0.782
Placebo BID	-0.24	± 0.473
JNJ-42165279 25 mg QD	0.32	± 0.179
JNJ-42165279 25 mg BID	-0.21	± 0.624

Restrictive behaviors

Group	Value	95% CI
Placebo QD	-0.14	± 0.440
Placebo BID	-0.12	± 0.580
JNJ-42165279 25 mg QD	0.11	± 0.275
JNJ-42165279 25 mg BID	-0.23	± 0.383

Social communication

Group	Value	95% CI
Placebo QD	-0.37	± 0.431
Placebo BID	-0.38	± 0.520
JNJ-42165279 25 mg QD	-0.23	± 0.480
JNJ-42165279 25 mg BID	-0.31	± 0.425

Self regulation

Group	Value	95% CI
Placebo QD	-0.47	± 0.506
Placebo BID	0.04	± 0.740
JNJ-42165279 25 mg QD	0.13	± 0.447
JNJ-42165279 25 mg BID	-0.29	± 0.637

Change From Baseline to Day 85 in the Autism Behavior Inventory-Clinician Interview (ABI-C) Domains Scores Secondary · Baseline (Day 1) to Day 85

The ABI-C covers the domains of ABI and was intended for completion by the clinician following an interview with caregiver and observation or interview with the individual with ASD, as appropriate. The ABI-C was designed to capture the behaviors of a person with ASD that have occurred over the past week. There were 14 items across each of the 5 domains: challenging behavior (2 items), mood and anxiety (2 items), restrictive behaviors (5 items), social communication (3 items), and self-regulation (2 items). The clinician rates the severity of behaviors or level of impairment on a scale of 1 (no

Challenging behavior

Group	Value	95% CI
Placebo QD	-0.64	± 1.107
Placebo BID	-0.26	± 0.739
JNJ-42165279 25 mg QD	-0.07	± 1.018
JNJ-42165279 25 mg BID	-0.40	± 1.030

Mood and anxiety

Group	Value	95% CI
Placebo QD	-0.36	± 0.690
Placebo BID	-0.44	± 0.859
JNJ-42165279 25 mg QD	-0.07	± 0.450
JNJ-42165279 25 mg BID	-0.60	± 1.270

Restrictive behaviors

Group	Value	95% CI
Placebo QD	-0.29	± 0.430
Placebo BID	-0.47	± 0.686
JNJ-42165279 25 mg QD	-0.43	± 0.582
JNJ-42165279 25 mg BID	-0.52	± 0.863

Social communication

Group	Value	95% CI
Placebo QD	0.05	± 0.300
Placebo BID	-0.59	± 0.669
JNJ-42165279 25 mg QD	-0.05	± 0.525
JNJ-42165279 25 mg BID	-0.70	± 0.993

Self regulation

Group	Value	95% CI
Placebo QD	-0.14	± 0.627
Placebo BID	-0.41	± 1.029
JNJ-42165279 25 mg QD	-0.07	± 0.189
JNJ-42165279 25 mg BID	-0.22	± 0.862

Change From Baseline to Day 85 in the Clinical Global Impression-Severity (CGI-S) Scale Score Secondary · Baseline (Day 1) to Day 85

The CGI-S 7-point scale was a global assessment that measures the clinician's impression of the severity of illness of the participant. A rating scale of 1 to 7 was used, with 1="normal, not at all ill" and 7="among the most extremely ill". Higher score indicated more severe illness.

Group	Value	95% CI
Placebo BID	0.0	-2 – 1
JNJ-42165279 25 mg BID	0.0	-3 – 1

Change From Baseline to Day 85 in the Repetitive Behavior Scale - Revised (RBS-R) Subscale Score Secondary · Baseline (Day 1) to Day 85

The RBS-R was a 43-item report scale to indicate the occurrence of repetitive behaviors and degree to which a behavior was a problem scored on a range between 0 (behavior did not occur) to 3 (behavior occurred and was a severe problem). There are 6 subscale scores: Stereotyped Behavior (items 1 to 6), self-injurious behavior (items 7 to 14), compulsive behavior (items 15 to 22), ritualistic behavior (items 23 to 28), sameness behavior (items 29 to 39), and restricted behavior (items 40 to 43). The ranges for RBS-R subscale scores were stereotyped behavior: 0 to 18; self-injurious behavior: 0 t

stereotyped behavior

Group	Value	95% CI
Placebo QD	-1.6	± 2.07
Placebo BID	-0.6	± 2.34
JNJ-42165279 25 mg QD	-1.0	± 1.83
JNJ-42165279 25 mg BID	-0.8	± 1.89

self-injurious behavior

Group	Value	95% CI
Placebo QD	-1.4	± 1.99
Placebo BID	0.2	± 2.15
JNJ-42165279 25 mg QD	-0.7	± 1.60
JNJ-42165279 25 mg BID	-1.2	± 2.05

compulsive behavior

Group	Value	95% CI
Placebo QD	-1.7	± 4.61
Placebo BID	-0.4	± 2.95
JNJ-42165279 25 mg QD	-1.0	± 1.53
JNJ-42165279 25 mg BID	-0.8	± 2.33

ritualistic behavior

Group	Value	95% CI
Placebo QD	-2.6	± 3.21
Placebo BID	-0.5	± 3.71
JNJ-42165279 25 mg QD	-1.6	± 2.15
JNJ-42165279 25 mg BID	-1.1	± 3.63

sameness behavior

Group	Value	95% CI
Placebo QD	-6.3	± 4.89
Placebo BID	-2.0	± 4.98
JNJ-42165279 25 mg QD	-2.3	± 3.15
JNJ-42165279 25 mg BID	-2.9	± 6.39

restricted behavior

Group	Value	95% CI
Placebo QD	-0.4	± 3.05
Placebo BID	-0.5	± 1.83
JNJ-42165279 25 mg QD	-0.3	± 2.81
JNJ-42165279 25 mg BID	-0.7	± 2.55

Change From Baseline to Day 85 in the Zarit Burden Interview (ZBI) Global Score Secondary · Baseline (Day 1) to Day 85

The ZBI short version scale consists of 22 items designed to assess the psychological burden experienced by a caregiver. Items ask how the caregiver felt and their responses range from 0 to 4, where 0 = never and 4 = nearly always. The ZBI global score was the sum of all item score and ranges from 0 to 88 with higher scores indicating a higher burden. A negative change in the ZBI global score from baseline representing improvement.

Group	Value	95% CI
Placebo QD	-2.0	± 12.12
Placebo BID	-2.2	± 10.89
JNJ-42165279 25 mg QD	-4.3	± 7.83
JNJ-42165279 25 mg BID	-3.9	± 10.20

Adverse events — posted to ClinicalTrials.gov

Time frame: Serious adverse events (SAEs) and other adverse events (AEs): From Day 1 up to 6 days post last dose of study drug (up to 91 days); All-cause mortality: From screening (Day -26) up to 99 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo QD

Serious: 0/7 (0%)

Deaths: 0/7

Placebo BID

Serious: 0/30 (0%)

Deaths: 0/31

JNJ-42165279 25 mg QD

Serious: 0/8 (0%)

Deaths: 0/8

JNJ-42165279 25 mg BID

Serious: 0/32 (0%)

Deaths: 0/32

Other adverse events (18 terms — click to expand)

Reaction	System	Placebo QD	Placebo BID	JNJ-42165279 25 mg QD	JNJ-42165279 25 mg BID
Alanine Aminotransferase Increased	Investigations	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Early Repolarisation Syndrome	Cardiac disorders	—	—	—	—
Motion Sickness	Ear and labyrinth disorders	—	—	—	—
Abdominal Discomfort	Gastrointestinal disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Medical Device Site Rash	General disorders	—	—	—	—
Seasonal Allergy	Immune system disorders	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—
Upper Respiratory Tract Infection	Infections and infestations	—	—	—	—
Ligament Sprain	Injury, poisoning and procedural complications	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—
Increased Appetite	Metabolism and nutrition disorders	—	—	—	—
Lethargy	Nervous system disorders	—	—	—	—
Sedation	Nervous system disorders	—	—	—	—
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Acne	Skin and subcutaneous tissue disorders	—	—	—	—

Data from ClinicalTrials.gov NCT03664232 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the efficacy of JNJ-42165279 compared with placebo in the improvement of symptoms of Autism Spectrum Disorder (ASD) during 12 weeks of treatment using the Autism Behavior Inventory (ABI).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Signalling pathways in autism spectrum disorder: mechanisms and therapeutic implications.
Jiang CC, Lin LS, Long S, Ke XY, et al · · 2022 · cited 157× · PMID 35817793 · DOI 10.1038/s41392-022-01081-0
The effects of inhibition of fatty acid amide hydrolase (FAAH) by JNJ-42165279 in social anxiety disorder: a double-blind, randomized, placebo-controlled proof-of-concept study.
Schmidt ME, Liebowitz MR, Stein MB, Grunfeld J, et al · · 2021 · cited 67× · PMID 33070154 · DOI 10.1038/s41386-020-00888-1
Meet Your Stress Management Professionals: The Endocannabinoids.
deRoon-Cassini TA, Stollenwerk TM, Beatka M, Hillard CJ. · · 2020 · cited 46× · PMID 32868170 · DOI 10.1016/j.molmed.2020.07.002
Therapeutic potential and safety considerations for the clinical use of synthetic cannabinoids.
Sholler DJ, Huestis MA, Amendolara B, Vandrey R, et al · · 2020 · cited 33× · PMID 33086126 · DOI 10.1016/j.pbb.2020.173059
Efficacy and safety of JNJ-42165279, a fatty acid amide hydrolase inhibitor, in adolescents and adults with autism spectrum disorder: a randomized, phase 2, placebo-controlled study.
Klein ME, Bangerter A, Halter RJ, Cooper K, et al · · 2024 · cited 12× · PMID 39414987 · DOI 10.1038/s41386-024-02001-2
Visual Preference for Biological Motion in Children and Adults with Autism Spectrum Disorder: An Eye-Tracking Study.
Kaliukhovich DA, Manyakov NV, Bangerter A, Ness S, et al · · 2021 · cited 10× · PMID 32951157 · DOI 10.1007/s10803-020-04707-w
Cannabinoids, Inner Ear, Hearing, and Tinnitus: A Neuroimmunological Perspective.
Perin P, Mabou Tagne A, Enrico P, Marino F, et al · · 2020 · cited 8× · PMID 33329293 · DOI 10.3389/fneur.2020.505995
ACNP 61<sup>st</sup> Annual Meeting: Poster Abstracts P271-P540.
· 2022 · cited 7× · PMID 36456694 · DOI 10.1038/s41386-022-01485-0

Verify or expand the search:

Other trials of JNJ-42165279

Trials testing the same drug.

NCT03564379 — A Single and Multiple Dose Study to Investigate Safety, Tolerability and Pharmacokinetics of JNJ-42165279 in Healthy Jap · Phase 1 · completed
NCT02498392 — An Efficacy, Safety and Tolerability Study of JNJ-42165279 in Participants With Major Depressive Disorder With Anxious D · Phase 2 · completed
NCT02432703 — A Safety and Efficacy Study of JNJ-42165279 in Participants With Social Anxiety Disorder · Phase 2 · completed

Other recruiting trials for Autism Spectrum Disorder

Currently open trials in the same condition.

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NCT07432776 — Effect of an 8-Week Pickleball Program for Adults With Autism: A Feasibility Trial With a Delayed-Control Design · EARLY_PHASE1 · recruiting

Other Janssen Research & Development, LLC trials

Trials by the same sponsor.

NCT07518186 — A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma · Phase 3 · not yet recruiting
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NCT07499232 — A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease · Phase 3 · not yet recruiting
NCT07438496 — A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus · Phase 3 · recruiting
NCT07227025 — A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer · Phase 1, PHASE2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03664232 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Janssen Research & Development, LLC
Last refreshed: 23 April 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03664232.

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