Trial reportThe Journal of investigative dermatology2022
Safety and Efficacy of Lenabasum, a Cannabinoid Receptor Type 2 Agonist, in Patients with Dermatomyositis with Refractory Skin Disease: A Randomized Clinical Trial.
Trial report in The Journal of investigative dermatology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02466243 (A Phase 2, Double-blind, Randomized, Placebo-controlled Study to Investigate the Safety, Tolerability, and Efficacy of JBT-101 in Subjects With Dermatomyositis), which is not on this map. Cited by 31 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 2, Double-blind, Randomized, Placebo-controlled Study to Investigate the Safety, Tolerability, and Efficacy of JBT-101 in Subjects With Dermatomyositis
Who cites it
31 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Non-targeted immunosuppressive and immunomodulatory therapies for idiopathic inflammatory myopathies.The Cochrane database of systematic reviews · 2025Pooled it
- Targeted immunosuppressive and immunomodulatory therapies for idiopathic inflammatory myopathies.The Cochrane database of systematic reviews · 2025Pooled it
- Cannabis and cannabinoids in dermatology: a systematic review and meta-analysis of quantitative outcomes.Frontiers in pharmacology · 2025Pooled it
- Efficacy and Safety of Subcutaneous Abatacept Plus Standard Treatment for Active Idiopathic Inflammatory Myopathy: Phase 3 Randomized Controlled Trial.Arthritis & rheumatology (Hoboken, N.J.) · 2025Trial
- Diverse Lenabasum pathway activation in dermatomyositis patients' blood.Scientific reports · 2025Trial
- Long-Term Safety and Efficacy of Lenabasum, a Cannabinoid Receptor Type 2 Agonist, in Patients with Dermatomyositis with Refractory Skin Disease: Follow-Up Data from a 3-Year Open-Label Extension Study.JID innovations : skin science from molecules to population health · 2025Trial
- Evaluating the Abuse Potential of Lenabasum, a Selective Cannabinoid Receptor 2 Agonist.The Journal of pharmacology and experimental therapeutics · 2024Trial
- The Effects of CB2R Activation on Inflammatory Pathways in Dermatomyositis.Biomedicines · 2026Article
- High acceptance and reported efficacy of cannabis for pain management in patients with rheumatic diseases in Germany: a postlegalisation survey.EULAR rheumatology open · 2025Article
- Dermatomyositis: focus on cutaneous features, etiopathogenetic mechanisms and their implications for treatment.Seminars in immunopathology · 2025Review
- Development and Evaluation of the Dermatomyositis Outcomes for Muscle and Skin as an Outcome Measure in Dermatomyositis Clinical Trials.JID innovations : skin science from molecules to population health · 2025Article
- Understanding the Role of Type I Interferons in Cutaneous Lupus and Dermatomyositis: Toward Better Therapeutics.Arthritis & rheumatology (Hoboken, N.J.) · 2025Review
- Repolarization of inflammatory macrophages into reparative stage targeting cannabinoid receptor2: a potential perspective to dampen lung injury/ARDS.Frontiers in pharmacology · 2025Review
- Critical Analysis of Cytoplasmic Progression of Inflammatory Signaling Suggests Potential Pharmacologic Targets for Wound Healing and Fibrotic Disorders.Biomedicines · 2024Review
- Updates in Dermatomyositis: Newer Treatment Options and Outcome Measures From Dermatologic Perspectives.Annals of dermatology · 2024Review
- Development of the Cutaneous Dermatomyositis Investigator Global Assessment (CDM-IGA): A De Novo IGA of Cutaneous Manifestations of Dermatomyositis.Dermatology and therapy · 2024Article
- The Impact of the CBMolecules (Basel, Switzerland) · 2024Review
- Possible Role of Cannabis in the Management of Neuroinflammation in Patients with Post-COVID Condition.International journal of molecular sciences · 2024Review
- A comprehensive review of dermatomyositis treatments - from rediscovered classics to promising horizons.Expert review of clinical immunology · 2024Review
- Rescue therapy of antisynthetase syndrome with CD19-targeted CAR-T cells after failure of several B-cell depleting antibodies.Rheumatology (Oxford, England) · 2024Article
Corrections and comments
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Authors and funding
15 authors.
Funding
Abstract
backgroundTreatment options are limited for skin disease in dermatomyositis. Lenabasum is a cannabinoid receptor type 2 agonist that triggers the resolution of inflammation.
objectiveThe objective of this study was to evaluate the safety and efficacy of lenabasum in patients with refractory cutaneous dermatomyositis.
designThis study was a single-center, double-blind, randomized, placebo-controlled phase 2 study conducted from July 2015 to August 2017. POPULATION: The population included subjects aged ≥18 years with at least moderately active dermatomyositis skin activity by Cutaneous Dermatomyositis Disease Area and Severity Index activity ≥ 14 and failure or intolerance to hydroxychloroquine.
interventionParticipants received 20 mg lenabasum daily for 28 days and then 20 mg twice per day for 56 days or placebo. MAIN OUTCOMES AND MEASURES: The primary outcome was a change in Cutaneous Dermatomyositis Disease Area and Severity Index activity. Safety and other secondary efficacy assessments were performed till day 113.
resultsA total of 22 subjects were randomized to lenabasum (n = 11) or placebo (n = 11). No serious or severe adverse events were related to lenabasum, and no participants discontinued the study. The adjusted least-squares mean for Cutaneous Dermatomyositis Disease Area and Severity Index activity decreased more for lenabasum, and the difference was significant on day 113 (least-squares mean [standard error] difference = ‒6.5 [3.1], P = 0.038). Numerically greater improvements were seen in multiple secondary efficacy outcomes and biomarkers with lenabasum.
conclusionLenabasum treatment was well tolerated and was associated with greater improvement in Cutaneous Dermatomyositis Disease Area and Severity Index activity and multiple efficacy outcomes.
trial registrationThis study was registered at ClinicalTrials.gov, NCT02466243.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.