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Cannabinoid Receptor Agonist

Lenabasum 20 mg for Dermatomyositis (DETERMINE Trial)

Phase 3
Waitlist Available
Led By Victoria P Werth, MD
Research Sponsored by Corbus Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52
Awards & highlights

DETERMINE Trial Summary

This study is evaluating whether a drug called lenabasum can improve muscle strength and function in people with dermatomyositis.

DETERMINE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy of lenabasum 20 mg BID compared to placebo BID as measured by Total Improvement Score (TIS)
Secondary outcome measures
Change in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) activity score
Change in Forced vital capacity (FVC) absolute, in all subjects and those with interstitial lung disease (ILD) at Baseline.
Change in Forced vital capacity (FVC) percent predicted, in all subjects and those with interstitial lung disease (ILD) at Baseline.
+6 more

Side effects data

From 2020 Phase 2 trial • 447 Patients • NCT03451045
73%
Respiratory, thoracic and mediastinal
40%
Infections and infestations
26%
Gastrointestinal disorders
25%
Infective pulmonary exacerbation of cystic fibrosis
25%
General disorders and administration site conditions
25%
Investigations
20%
Nervous system
16%
Musculoskeletal and connective tissues
11%
Psychiatric
6%
Renal and urinary
6%
Skin and subcutaneous
3%
Immune system disorders
1%
Haemoptysis
1%
Distal intestinal obstruction syndrome
1%
Dehydration
1%
Headache
1%
Renal colic
1%
Ureterolithiasis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lenabasum 5 mg BID
Lenabasum 20 mg BID
Placebo

DETERMINE Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Lenabasum 5 mgExperimental Treatment1 Intervention
Subjects will receive lenabasum 5 mg twice daily
Group II: Lenabasum 20 mgExperimental Treatment1 Intervention
Subjects will receive lenabasum 20 mg twice daily
Group III: PlaceboPlacebo Group1 Intervention
Subjects will receive placebo twice daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenabasum 20 mg
2017
Completed Phase 3
~630
Lenabasum 5 mg
2017
Completed Phase 3
~630

Find a Location

Who is running the clinical trial?

Corbus Pharmaceuticals Inc.Lead Sponsor
7 Previous Clinical Trials
1,490 Total Patients Enrolled
1 Trials studying Dermatomyositis
22 Patients Enrolled for Dermatomyositis
Victoria P Werth, MDPrincipal InvestigatorUniversity of Pennsylvania
1 Previous Clinical Trials
5 Total Patients Enrolled
Chester V Oddis, MDPrincipal InvestigatorUniversity of Pittsburgh Department of Medicine/Division of Rheumatology

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
UCLA Division of Rheumatology
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis
2018. "Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03813160.
~28 spots leftby Apr 2025
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