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NCT03813160: DETERMINE
Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis
Phase 3 trial testing Lenabasum 20 mg in Dermatomyositis in 176 participants. Completed in 5 October 2021.
31 March 2021
Quick facts
| Lead sponsor | Corbus Pharmaceuticals Inc. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 176 |
| Start date | 17 December 2018 |
| Primary completion | 31 March 2021 |
| Estimated completion | 5 October 2021 |
| Sites | 54 locations across Italy, Japan, Sweden, United Kingdom, Germany, Hungary, Poland, South Korea |
Drugs / interventions tested
- Lenabasum 20 mg — full drug profile →
- Lenabasum 5 mg — full drug profile →
- Placebo
Conditions studied
- Dermatomyositis — all drugs for Dermatomyositis →
Sponsor
Corbus Pharmaceuticals Inc. — full company profile →
Who can join
18 and older, any sex, with Dermatomyositis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of dermatomyositis. Approximately 150 subjects will be enrolled in this study at about 60 sites in North America, Europe, and Asia. The planned duration of double-blind treatment with study drug is up to 52 weeks.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
A Guide to Targeting the Endocannabinoid System in Drug Design.
Stasiulewicz A, Znajdek K, Grudzień M, Pawiński T, et al · · 2020 · cited 76× · PMID 32316328 · DOI 10.3390/ijms21082778 -
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 -
Management of Connective Tissue Disease-related Interstitial Lung Disease.
Ahmed S, Handa R. · · 2022 · cited 24× · PMID 35530438 · DOI 10.1007/s13665-022-00290-w -
Pruritus: A Sensory Symptom Generated in Cutaneous Immuno-Neuronal Crosstalk.
Szöllősi AG, Oláh A, Lisztes E, Griger Z, et al · · 2022 · cited 23× · PMID 35321329 · DOI 10.3389/fphar.2022.745658 -
Clinical pearls and promising therapies in myositis.
Connolly CM, Paik JJ. · · 2023 · cited 8× · PMID 37158055 · DOI 10.1080/1744666x.2023.2212162 -
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 -
Candidate Therapeutics by Screening for Multitargeting Ligands: Combining the CB2 Receptor With CB1, PPARγ and 5-HT4 Receptors.
El-Atawneh S, Goldblum A. · · 2022 · cited 7× · PMID 35295337 · DOI 10.3389/fphar.2022.812745 -
Promising and Upcoming Treatments in Myositis.
Smith LN, Paik JJ. · · 2020 · cited 7× · PMID 32845402 · DOI 10.1007/s11926-020-00943-2
Verify or expand the search:
- PubMed search for NCT03813160
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Lenabasum 20 mg
Trials testing the same drug.
- NCT03451045 — Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis · Phase 2 · completed
- NCT03398837 — Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis · Phase 3 · terminated
Other recruiting trials for Dermatomyositis
Currently open trials in the same condition.
- NCT06672822 — Intralesional Injection of STS in Treatment of Calcinosis · Phase 2 · recruiting
- NCT06698796 — A Study to Understand How the Study Medicine Dazukibart Works in People With Idiopathic Inflammatory Myopathies · Phase 3 · recruiting
- NCT06732674 — Home Based Clinical Management of Interstitial Lung Disease in Systemic Rheumatic Diseases · NA · recruiting
- NCT06686524 — Clinical Study of CD19 Targeted Universal Chimeric Antigen Receptor T Lymphocytes (UCAR-T) for the Treatment of Refracto · Phase 1 · recruiting
- NCT07037472 — Photoacoustic/Ultrasound Imaging in Patients of Dermatomyositis With Calcinosis Cutis: Characteristic Findings and Treat · NA · recruiting
Other Corbus Pharmaceuticals Inc. trials
Trials by the same sponsor.
- NCT07310901 — A 2-part, Phase 1b Clinical Study Designed to Evaluate the Safety, PK, and Efficacy of CRB-913 in Participants With Obes · Phase 1 · recruiting
- NCT06603844 — First-in-human Study of CRB-601-01 to Treat Patients With Advanced Solid Tumor. · Phase 1, PHASE2 · recruiting
- NCT06265727 — A Phase 1/2 Study to Investigate CRB-701 in Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT03451045 — Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis · Phase 2 · completed
- NCT03398837 — Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis · Phase 3 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03813160 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 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 Corbus Pharmaceuticals Inc.
- Last refreshed: 16 August 2022
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/NCT03813160.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing