A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis
JBT101-DM-002 A Phase 3 safety and efficacy study of lenabasum in dermatomyositis subjects
Corbus Pharmaceuticals, Inc.
-
+1 781 774 9687
-
CMIC Co., Ltd.
-
-
ClinicalTrialInformation@cmic.co.jp
completed
Aug. 21, 2019
25
Interventional
A multicenter, interventional, double-blind, randomized, placebo-controlled study.
treatment purpose
3
1. Able to understand and voluntarily sign the informed consent
2. Male or female 18 and more years of age at the time of signing the informed consent
3. Fulfill one of the following criteria for DM: a. Bohan and Peter's criteria for probable or definite DM(Bohan and Peter, 1975a; Bohan and Peter 1975b)
b. ACR/EULAR criteria (Lundberg et al, 2017)
4. Subject has active DM as determined by the investigator
5. Disease activity/severity fulfils one of the following three criteria: i. MDGA 3 and more cm (0-10 cm scale) and MMT-8 score 142 and less (out of 150 total possible)
ii. Sum of MDGA, PtGA and EMGA VAS scores is 10 and more cm (all scales individually on 0-10 cm scale)
iii. MDGA 3 and more cm and CDASI activity score of more than 14
6. Stable doses of immunosuppressive medications for DM as defined by: a. Unchanged dose of oral corticosteroids 20 and less mg per day prednisone or equivalent for 4 and more weeks before Visit 1
b. Unchanged dose of immunosuppressive medications other than oral corticosteroids for 8 and more weeks before Screening
7. Willing to not start or stop any immunosuppressive medications for DM from Screening through end of study, unless a change is part of the protocol or considered in the subject's best medical interest by the site investigator or another physician who has primary responsibility for treating the subject's DM.
8. Willing to not use any cannabinoids, including recreational marijuana, medical marijuana and other prescription cannabinoids from Screening through end of study.
9. Able to adhere to the study visit schedule and other protocol requirements and follow study restrictions.
10. Women of childbearing potential (WOCBP) must not be pregnant or breastfeeding and they or their male sexual partner must be using at least one acceptable method of contraception for at least 4 weeks before Visit 1 and be willing to continue its use for at least 4 weeks after discontinuation of study product.
11. Male subjects must be willing to follow acceptable contraceptive requirements and should not get anyone pregnant while they are taking the study product or within 4 weeks after taking the last dose of the study product, during which time period they or their female partner must be willing to use at least one recommended method of contraception.
1. Unstable DM or DM with end-stage organ involvement at Screening or Visit 1, including: a. On an organ transplantation list or has received an organ transplant, except corneal transplant
b. Interstitial lung disease requiring constant oxygen therapy. This excludes oxygen used to aid sleep or exercise
c. Pulmonary hypertension requiring constant oxygen therapy. This excludes oxygen used to aid sleep or exercise
d. Subjects requiring supplemental tube feeding or parenteral nutrition
2. Certain medications at Visit 1, including: a. Treatment with intravenous or intramuscular corticosteroids within 4 weeks before Visit 1 (Note: treatment with intra-articular corticosteroids within 4 weeks before Visit 1 is allowed)
b. Treatment with oral or intravenous antibiotics or antiviral treatments for new bacterial or viral infections within 4 weeks of Visit 1. This does not include prophylactic antibiotics or antiviral treatments
c. Any investigational agent within 30 days or 5 therapeutic half-lives of that agent whichever is longer, before Visit 1
3. Significant diseases or conditions other than DM that may influence response to the study product or safety, such as:
a. Acute or chronic hepatitis B or C infection
b. Human immunodeficiency virus infection
c. History of active tuberculosis or positive tuberculosis test without a completed course of appropriate treatment. Having already completed at least 1 month of appropriate treatment is eligible.
d. Evidence of cancer (except for treated basal or squamous cell carcinoma of the skin or cervical carcinoma in situ) within 3 years of Visit 1
Note: Overlap with features of SSc, systemic lupus erythematosus, Sjogren's syndrome, or rheumatoid arthritis is allowed if the dominant clinical disease is DM.
4. Any of the following values for laboratory tests at Screening:
a. A positive pregnancy test in women of child-bearing potential (WOCBP) - also at Visit 1
b. Hemoglobin less than 9 g/dL in males and less than 8 g/dL in females
c. Neutrophils less than 1.0 times 10^9/L
d. Platelets less than 75 times 10^9/L
e. Creatinine clearance less than 50 mL/min/1.73m^2 on screening blood test, per the Modification of Diet in Renal Disease Study or in 24 hour urine creatine clearance measurement
5. Any known hypersensitivity to lenabasum or any of its excipie
6.Any medical, phychiatric or substance abuse condition, concurrent medical therapies, or abnormal laboratory values, that in the opinion of the site investivator may put the subject at greater safety risk, influence response to study product, or interfere with study assessments.
7. Subjects who have been accommodated in an institution as a result of official or judicial decision.
18age old over
No limit
Both
Dermatomyositis
investigational material(s)
Generic name etc : Lenabasum
INN of investigational material : Lenabasum
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investigational material : Oral administration as a lenabasum 20 mg or 5 mg twice a day
control material(s)
Generic name etc : Placebo
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : Oral administration twice a day
efficacy
confirmatory
The Total Improvement Score(TIS) by the 2016 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Myositis Response Criteria compared to placebo at Week 52.
1. Physician global activity (MDGA)
2. Patient global activity (PtGA)
3. Manual Muscle Testing (MMT)
4. Health Assessment Questionnaire (HAQ)
5. Muscle enzymes
6. Extramuscular global activity (EMGA)
safety
efficacy
Change from Baseline compared to placebo at Week 52 in:
1. Mean MMT-8 score
2. Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) activity score
3. Proportion of subjects who achieve clear or almost clear skin on the Investigator Global Assessment(IGA) scale of skin activity
4. Short Form - 36 (SF-36) physical functioning domain score
5. Corticosteroid dose
6. Forced Vital Capacity (FVC) % predicted
7. Each Component of the TIS (MDGA, PtGA, HAQ, muscle enzymes, and EMGA)
Adverse events (AEs) and changes in: vital signs, physical examinations, blood and urine laboratory safety tests, and ECGs associated with lenabasum treatment
Number of subjects who permanently discontinue study product due to AEs probably- or definitely-related to treatment
Corbus Pharmaceuticals, Inc. / CMIC Co., Ltd.
-
Corbus Pharmaceuticals, Inc.
-
Wakayama Medical University Hospital IRB Membership Roster
