A study of safety and efficacy of lenabasum in dermatomyositis patients
- Conditions
- Dermatomyositis (DM)MedDRA version: 20.0Level: PTClassification code 10012503Term: DermatomyositisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2018-003273-10-HU
- Lead Sponsor
- Corbus Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
1. Able to understand and voluntarily sign the informed consent
2. Male or female = 18 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
b. ACR/EULAR criteria
4. Subject has active DM as determined by the investigator
5. Disease activity/severity fulfils one of the following three criteria:
i. MDGA = 3 cm (0-10 cm scale) and MMT-8 score = 142 (out of 150 total possible)
ii. Sum of MDGA, PtGA and EMGA VAS scores is = 10 cm (all scales individually on 0-10 cm scale)
iii. MDGA = 3 cm and CDASI activity score of >14
6. Stable doses of immunosuppressive medications for DM as defined by:
a. Unchanged dose of oral corticosteroids = 20 mg per day prednisone or equivalent for = 4 weeks before Visit 1
b. Unchanged dose of immunosuppressive medications other than oral corticosteroids for = 8 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 must be using at least one recommended 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 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 partner must be willing to use at least one recommended method of contraception.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 130
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
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 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 (HBsAg or HCV RNA positivity)
b. Human immunodeficiency virus infection
c. History of active tuberculosis or positive tuberculosis test without a completed course of appropriate treatment or having already completed at least 1 month of ongoing appropriate treatment
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 < 9 g/dL in males and < 8 g/dL in females
c. Neutrophils < 1.0 × 10^9/L
d. Platelets < 75 × 10^9/L
e. Creatinine clearance < 50 mL/min on screening blood test, per the Modification of Diet in Renal Disease Study or in 24 hour urine creatine clearance measurement
5. Significant diseases or conditions other than DM or concurrent medical therapies at Screening or Visit 1, including a history of non-compliance with medical treatments, that may put the subject at greater safety risk, influence response to study product, or interfere with study assessments.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method