A Phase 3 interventional study of Lenabasum 20 mg and Lenabasum 5 mg in Dermatomyositis, sponsored by Corbus Pharmaceuticals Inc.. Completed at 54 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-16.
Sponsored by Corbus Pharmaceuticals Inc. · Phase 3, Interventional, and Treatment
Among 94 studies in Dermatomyositis with a site in United States — 30 open to participants now, 33 under way, 6 of them phase 3. Dermatomyositis · United States.
Among the 94 studies in Dermatomyositis with a site in United States, this one is the 12th largest by enrollment of the 73 interventional ones, is one of 4 that started in 2018, is one of 9 in phase 3, and was the 46th registered.
184 studies on the registry are indexed under Dermatomyositis; 63 are open to participants now.
This study's enrollment of 176 is above the median of 35 across 130 interventional studies indexed under Dermatomyositis.
Browse Dermatomyositis studies →30 of the 94 studies in Dermatomyositis with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 50 Dermatomyositis studies recruiting now, 24 (48%) set no upper age limit and 16 (32%) stop at 75 or younger; 15 take children under 18; 6 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →94 studies; the count open now beside each. This study's row is marked.
First in 1990; this study’s year is marked. 4 started in 2018.
Median enrollment 25 across the 73 interventional studies, 540 across the 18 observational. Of the 55 that completed or were terminated, 26 (47%) have results posted.
40 of 94 have an industry lead sponsor. The 10 most frequent:
Corbus Pharmaceuticals Inc. is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
Corbus Pharmaceuticals Inc. has 2 studies filed under Dermatomyositis — fewer than ten, so there is no comparison to draw.
5 of the studies in Dermatomyositis with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06284954argenxA Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis | 2026-11 |
| NCT06371417Chugai PharmaceuticalPhase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial) | 2027-03-31 |
| NCT06298019Stanford UniversityStudy of KYV-101 Anti-CD19 CAR T Therapy in Adult Dermatomyositis | 2027-04 |
| NCT06916806AstraZenecaA Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD5492 in Adult Participants With Systemic Lupus Erythematosus or Idiopathic Inflammatory Myopathies or Rheumatoid Arthritis. | 2027-05-05 |
| NCT07486869University of MiamiEmapalumab MDA5 Rapidly Progressive Interstitial Lung Disease (RP-ILD) Study | 2027-07 |
Among the 94 studies in Dermatomyositis with a site in United States, from their registry updates:
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.
Subjects will be randomized to receive lenabasum 20 mg twice per day, lenabasum 5 mg twice per day, or placebo twice per day in a 2:1:2 ratio. The primary efficacy outcome at Week 28 will compare lenabasum 20 mg BID to placebo the Total Improvement Score (TIS), which is a weighted composite measure of improvement from baseline in six endpoints: Physician Global Assessment of Disease Activity, Physician Assessment of Extramuscular Disease Activity, Patient Global Assessment of Disease Activity, Health Assessment Questionnaire (patient-reported disability), Manual Muscle Testing (MMT), and muscle enzymes.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Fulfill at least one of the following criteria for dermatomyositis:
Disease activity/severity fulfills at least one of the following three criteria:
Stable doses of medications for DM as defined by:
Exclusion Criteria:
Any of the following values for laboratory tests at Screening:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will receive lenabasum 20 mg twice daily
Drug: Lenabasum 20 mg
Subjects will receive lenabasum 5 mg twice daily
Drug: Lenabasum 5 mg
Subjects will receive placebo twice daily
Drug: Placebo
oral capsule
Also known as: JBT-101, anabasum
oral capsule
Also known as: JBT-101, anabasum
oral capsule
Efficacy of lenabasum 20 mg BID compared to placebo BID as measured by Total Improvement Score (TIS)
TIS from IMAC Core Set Measures (CSM) will be calculated following Aggarwal et al (2017) recommendations. Scores are based on a 0 - 100 scale; higher scores indicate better improvement in myositis.
Time frame: Week 28
Subjects who achieve Definition of Improvement (DOI)
Defined as ≥ 3 of 6 core set measures improved by ≥ 20% (relative to Baseline) with no more than 2 core set measures worsening by ≥ 25% (MMT-8 may not decrease by ≥ 25% from baseline)
Time frame: Week 28
Subjects who improve by at least one category on the Investigator Global Assessment (IGA) scale of skin activity
The IGA is used by the investigator to score overall skin disease on a 0 to 4 scale; higher scores indicate greater skin disease.
Time frame: Week 28
Change in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) activity score
CDASI is a validated outcome measure that systematically quantifies cutaneous DM disease activity and damage (Klein et al, 2007; Yassaee et al, 2010) Disease Activity Score is rated using three activity measures. The activity score ranges from 0 to 100. Higher scores indicate greater disease severity.
Time frame: Week 28
Subjects who achieve TIS >= 40 (at least moderate improvement)
TIS from IMAC Core Set Measures (CSM) will be calculated following Aggarwal et al (2017) recommendations. Scores are based on a 0 - 100 scale; higher scores indicate better improvement in myositis.
Time frame: Week 28
TIS in subjects receiving immunosuppressive therapies (including corticosteroids) for > 1 year at Baseline
TIS from IMAC Core Set Measures (CSM) will be calculated following Aggarwal et al (2017) recommendations. Scores are based on a 0 - 100 scale; higher scores indicate better improvement in myositis.
Time frame: Week 52
Change in Forced vital capacity (FVC) absolute, in all subjects and those with interstitial lung disease (ILD) at Baseline.
ILD is defined as a history of fibrosis on chest x-ray, a history of ILD on CT of lungs, and/or FVC% predicted \<80% at Screening or Visit 1
Time frame: Week 28
Change in Forced vital capacity (FVC) percent predicted, in all subjects and those with interstitial lung disease (ILD) at Baseline.
ILD is defined as a history of fibrosis on chest x-ray, a history of ILD on CT of lungs, and/or FVC% predicted \<80% at Screening or Visit 1
Time frame: Week 28
TIS at Visit 10
TIS from IMAC Core Set Measures (CSM) will be calculated following Aggarwal et al (2017) recommendations. Scores are based on a 0 - 100 scale; higher scores indicate better improvement in myositis.
Time frame: Week 52
TIS, lenabasum 5 mg BID versus placebo
TIS from IMAC Core Set Measures (CSM) will be calculated following Aggarwal et al (2017) recommendations. Scores are based on a 0 - 100 scale; higher scores indicate better improvement in myositis.
Time frame: Week 28
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Dec 2018 to primary completion in Mar 2021, 27 months.
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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lenabasum
Corbus Pharmaceuticals Inc.