Systemic Sclerosis (SSc) MedDRA version: 21.0 Level: LLT Classification code 10012977 Term: Diffuse systemic sclerosis System Organ Class: 100000004859
Conditions
Interventions
Product Name: Lenabasum
Product Code: JBT-101
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LENABASUM
CAS Number: 137945-48-3
Sponsors
Corbus pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Part A: 1. Fulfills the 2013 American College Rheumatology (ACR) criteria for systemic sclerosis (van den Hoogen, 2013). 2. Diffuse cutaneous SSc (skin thickening on upper arms proximal to the elbows, upper legs proximal to the knees, or trunk). 3. = 18 years of age at the time Informed Consent is signed. 4. Written informed consent from the subject. 5. Disease duration = 6 years from the first non-Raynaud’s symptom. If disease duration is > 3 years and = 6 years, then mRSS = 15. Subjects with disease duration > 3 years and = 6 years and mRSS = 15 will be limited to no more than 1/3rd of the subjects. 6. Patient Global Assessment = 3 or MDGA = 3. 7. Stable treatment for SSc = 28 days before Visit 1. 8. Willing to not start or stop any immunosuppressive medications for SSc from Visit 1 through Visit 11, unless a change is considered in the subject’s best medical interest by the site investigator or another physician who has primary responsibility for treating the subject’s SSc. 9. Willing not to use any cannabinoids including recreational marijuana, medical marijuana and other prescription cannabinoids from Screening through Visit 11. 10. Women of childbearing potential (WOCBP) must not be pregnant or breastfeeding at Screening or Visit 1 and must be using at least one highly effective method of contraception (failure rate =65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: Part A: 1. Unstable SSc or SSc with end-stage organ involvement at Screening or Visit 1, such as: a. On an organ transplantation list or has received an organ transplant (previous autologous bone marrow/stem cell transplantation is permitted, but such cases should be discussed individually with the medical monitor). b. Renal crisis within 1 year c. Interstitial lung disease requiring constant oxygen treatment. This excludes oxygen used to aid sleep or exercise. d. Pulmonary hypertension requiring constant oxygen treatment. This excludes oxygen used to aid sleep or exercise. e. Gastrointestinal dysmotility requiring total parenteral nutrition or hospitalization within 6 months before Visit 1. 2. Certain medications at Screening or Visit 1, including: a. Treatment with any oral prednisone > 10 mg per day or equivalent within 28 days before Visit 1. Treatment with intravenous corticosteroids within 28 days before Visit 1 is not allowed, and treatment with intra-articular corticosteroids within 28 days before Visit 1 is allowed (topical corticosteroids are allowed). b. New or increase in doses of any non-corticosteroid immunosuppressive medication within 8 weeks before Screening. c. Treatment with cyclophosphamide within 3 months before Visit 1. 3. Concomitant inflammatory myositis, rheumatoid arthritis, or systemic lupus erythematosus when definite classification criteria for those diseases are met (Bohan and Peter criteria for polymyositis and dermatomyositis [Bohan and Peter, 1975a; Bohan and Peter, 1975b;] 2010 rheumatoid arthritis classification criteria of ACR/ EULAR [Aletaha, 2010)] ACR revised criteria for the classification of systemic lupus erythematosus [Hochberg, 1997]). 4. SSc-like illnesses related to exposures or ingestions. 5. A positive test for anti-centromere antibody at Screening. If the subject is anti-centromere antibody positive and clearly has diffuse cutaneous SSC (see inclusion criteria #2), then the subject may be eligible and the investigator must discuss this situation with the Medical monitor to determine eligibility. 6. Significant diseases or conditions other than SSc that may influence response to the study product or safety, such as: a. A new bacterial or viral infection that was treated with oral or intravenous antibiotics or anti-viral treatments within 28 days before Visit 1. This does not include prophylactic antibiotic or anti-viral treatments, or treatment for gastrointestinal bacterial overgrowth. b. Acute or chronic hepatitis B or C infection. c. Human immunodeficiency virus (HIV) infection. d. History of active tuberculosis or positive tuberculosis test without a completed course of appropriate treatment or already completed at least 1 month of ongoing appropriate treatment. e. Evidence of required treatment for cancer (except for treated, localized basal or squamous cell carcinoma of the skin or cervical carcinoma in situ) within 3 years of Visit 1 7. Any of the following values for laboratory tests at Screening: a. A positive pregnancy test in WOCBP (also at Visit 1) b. Hemoglobin < 9 g/dL in males a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): - Efficacy: American College of Rheumatology (ACR) Provisional Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) score (lenabasum 20 mg BID) - Safety: Treatment Emergent Adverse Events (TEAE) from Day 1 ;Timepoint(s) of evaluation of this end point: at Week 52;Main Objective: To evaluate the efficacy of lenabasum compared to placebo in the treatment of SSc by assessing the American College of Rheumatology (ACR) Provisional Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) at Week 52.; Secondary Objective: 1. To evaluate the efficacy of lenabasum compared to placebo in the treatment of SSc by assessing change from Baseline in the modified Rodnan skin score (mRSS) at Week 52. 2. To evaluate the efficacy of lenabasum compared to placebo in the treatment of SSc by assessing the change from Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) score at Week 52. 3. To evaluate the efficacy of lenabasum compared to placebo in the treatment of SSc by assessing the change from Baseline in the forced vital capacity (FVC) % score predicted at Week 52. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Part A: Week 52 Part B: Week 108 ; Secondary end point(s): Efficacy: - modified Rodnan skin score (mRSS) (lenabasum 20 mg BID and 5 mg BID) - Health Assessment Questionnaire-Disability Index (HAQ-DI) score (lenabasum 20 mg BID and 5 mg BID) - Forced Vital Capacity (FVC) % predicted (lenabasum 20 mg BID and 5 mg BID) - American College of Rheumatology (ACR) Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) score (lenabasum 5 mg BID) Safety: - Tolerability (percentage of subjects discontinuing study product due to a TEAE probably or definitely related to study product) of lenabasum treatment or placebo treatment - Vital signs (systolic and diastolic blood pressure, pulse rate, respiratory rate, body temperature, and weight) recorded at each visit (Part A and Part B) - Laboratory safety tests obtained at each visit (Part A) and Week 1, Week 4, Week 20, Week 36, Week 52, Week 68, Week 84, and Week 100 (Part B) - Complete blood count (CBC) with cell differential and platelets - Metabolic panel that includes renal function, electrolytes, and liver function tests - Urine dipstick testing for blood, albumin/protein, and glucose - Physical examinations at Day 1, Week 26, and Week 52 (Part A) and each visit (Part B) - 12-lead ECGs: Day 1, Week 26, and Week 52 (Part A); Week 12, Week 44, Week 76, and Week 108 (Part B). - Late emerging AEs (2-year safety follow-up) | — |
Countries
Australia, Canada, France, Germany, Israel, Italy, Japan, Korea, Republic of, Netherlands, Poland, Spain, Switzerland, United Kingdom, United States
Contacts
Public ContactRegulatory Services
TMC Pharma Services Ltd
Outcome results
None listed