A Phase 2 interventional study of JBT-101 and Placebo in Dermatomyositis, sponsored by Corbus Pharmaceuticals Inc.. Terminated at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-01-19.
Sponsored by Corbus Pharmaceuticals Inc. · Phase 2, 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 39th largest by enrollment of the 73 interventional ones, is one of 6 that started in 2015, is one of 31 in phase 2, and was the 35th registered.
184 studies on the registry are indexed under Dermatomyositis; 63 are open to participants now.
This study's enrollment of 22 is below 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 to 70 Years · 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. 6 started in 2015.
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:
The purpose of this study is to evaluate the safety, tolerability and efficacy of JBT-101 in adult subjects with skin-predominant, dermatomyositis (DM) that is refractory to at least 3 months treatment with hydroxychloroquine.
Part A: An interventional, double-blind, randomized, placebo-control design will be used to test JBT-101 in about 22 eligible male or female subjects ≥ 18 and ≤ 70 years of age with moderate-to-severe active skin-predominant dermatomyositis.
Part B: A one-year open-label design to test JBT-101 in subjects who completed Part A without permanent discontinuation of study product because of safety or tolerability reasons.
Inclusion Criteria (Part A):
Inclusion Criteria (Part B):
Exclusion Criteria (Part A and B):
Any one 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.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
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.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
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.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Part A: JBT-101 20 mg capsule once a day on Days 1-28, then 20 mg capsule twice a day on Days 29-84. Part B: JBT-101 20 mg twice daily on Days 1 - 365 of the OLE.
Drug: JBT-101
Part A: Placebo capsule once a day on Days 1-28, then placebo capsule twice a day on Days 29-84. Part B: Placebo twice daily on Days 1 - 365 of the OLE.
Drug: Placebo
Part A: 20 mg once daily on Days 1-28, then 20 mg twice daily on Days 29-84. Part B: JBT-101 20 mg twice daily on Days 1 - 365 of the OLE.
Also known as: lenabasum
Part A: Once daily on Days 1-28, then twice daily on Days 29-84. Part B: Placebo twice daily on Days 1 - 365 of the OLE.
Change in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) From Baseline in Part A.
The CDASI is a validated outcome measure that systematically quantifies cutaneous DM disease activity, In the CDASI, DM skin disease activity is scored from 0 to 100 based on the physician's evaluation of erythema, scale, and erosion or ulceration at 15 anatomic locations as well as alopecia, Gottron's sign or papules on the hands, and periungual changes. A 5-point or greater decrease in the CDASI activity score indicates clinically relevant improvement based on statistical analysis using a receiver operating characteristic curve to maximize sensitivity and specificity
Time frame: Part A: 84-day treatment period (Change from the Baseline CDSAI score at Day 84)
Number of Participants With Treatment Emergent Adverse Events as a Measure of Safety and Tolerability
Number of participants with treatment emergent adverse events were assessed as a measure of safety and tolerability
Time frame: Part A: to Day 84
Change in Patient-reported Outcomes From Baseline at 84 Days for Part A
LS mean (SE) change from baseline to Week 6 (Day 84) for lenabasum vs. placebo using a mixed model repeated measures analysis The CDASI is a validated outcome measure that systematically quantifies cutaneous DM disease activity and damage, In the CDASI, the Damage Score is scored from 0 to 32 based on the physician's evaluation of poikiloderma and calcinosis. 0 representing no damage and 32 representing the greatest level of damage.
Time frame: Part A: 84-day treatment period
| Milestone | JBT-101 | Placebo |
|---|---|---|
| Started | 11 | 11 |
| Completed | 11 | 11 |
| Not completed | 0 | 0 |
| Milestone | JBT-101 | Placebo |
|---|---|---|
| Started | 11 | 10 |
| Completed | 0 | 0 |
| Not completed | 11 | 10 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 2 |
| Withdrew: Sponsor decision | 8 | 6 |
| Withdrew: Missing | 2 | 2 |
The CDASI is a validated outcome measure that systematically quantifies cutaneous DM disease activity, In the CDASI, DM skin disease activity is scored from 0 to 100 based on the physician's evaluation of erythema, scale, and erosion or ulceration at 15 anatomic locations as well as alopecia, Gottron's sign or papules on the hands, and periungual changes. A 5-point or greater decrease in the CDASI activity score indicates clinically relevant improvement based on statistical analysis using a receiver operating characteristic curve to maximize sensitivity and specificity
| CDASI Activity Score | Lenabasum | Placebo |
|---|---|---|
| Change in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) From Baseline in Part A. | -8.0 ± 8.16 | -5.5 ± 5.56 |
Number of participants with treatment emergent adverse events were assessed as a measure of safety and tolerability
| Participants | Lenabasum | Placebo |
|---|---|---|
| Any TEAE | 11 | 8 |
| Any serious TEAE | 0 | 0 |
| Any TEAE leading to discontinuation | 0 | 0 |
| Any severe TEAE | 0 | 0 |
| No TEAE | 0 | 3 |
LS mean (SE) change from baseline to Week 6 (Day 84) for lenabasum vs. placebo using a mixed model repeated measures analysis The CDASI is a validated outcome measure that systematically quantifies cutaneous DM disease activity and damage, In the CDASI, the Damage Score is scored from 0 to 32 based on the physician's evaluation of poikiloderma and calcinosis. 0 representing no damage and 32 representing the greatest level of damage.
| CDASI Damage Score | Placebo | Lenabasum 20 mg BID |
|---|---|---|
| Change in Patient-reported Outcomes From Baseline at 84 Days for Part A | -5.5 ± 5.56 | -8.0 ± 8.16 |
Collected over 84 days. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| JBT-101 | 0/11 (0%) | 0/11 (0%) | 11/11 (100%) |
| Placebo | 0/11 (0%) | 0/11 (0%) | 11/11 (100%) |
| Event | JBT-101 | Placebo |
|---|---|---|
| DizzinessNervous system disorders | 5/11 | 2/11 |
| Dry mouthGastrointestinal disorders | 4/11 | 1/11 |
| DiarrhoeaGastrointestinal disorders | 3/11 | 1/11 |
| FatigueGeneral disorders | 1/11 | 3/11 |
| DyspepsiaGastrointestinal disorders | 2/11 | 0/11 |
| NauseaGastrointestinal disorders | 1/11 | 2/11 |
| Upper respiratory tract infectionInfections and infestations | 0/11 | 2/11 |
| FallInjury, poisoning and procedural complications | 2/11 | 0/11 |
| Increased appetiteMetabolism and nutrition disorders | 2/11 | 1/11 |
| HeadacheNervous system disorders | 2/11 | 0/11 |
Numbers reflect all randomized subjects; all subjects were included in the safety, modified intent-to-treat, and per protocol populations
| Age, Continuous(years) | JBT-101 | Placebo | Total |
|---|---|---|---|
| Mean | 53.1 ± 9.31 | 52.5 ± 10.44 | 52.8 ± 9.66 |
| Sex: Female, Male(Participants) | JBT-101 | Placebo | Total |
|---|---|---|---|
| Female | 10 | 11 | 21 |
| Male | 1 | 0 | 1 |
| Ethnicity (NIH/OMB)(Participants) | JBT-101 | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 0 | 3 |
| Not Hispanic or Latino | 8 | 11 | 19 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race(Participants) | JBT-101 | Placebo | Total |
|---|---|---|---|
| White | 11 | 10 | 21 |
| Black or African American | 0 | 1 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
The record gives a start of Jun 2015, a primary completion of Aug 2017 and a completion of Jan 2021. It does not say whether these dates are actual or estimated.
Results were first posted in Jan 2023, 5 years 5 months after primary completion. A results delay was requested in Jan 2019.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Dec 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.