A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis
Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis (RESOLVE-1)
Corbus Pharmaceuticals, Inc.
Medical Dr Bradley Bloom: bradley.bloom@corbuspharma.com
Corbus Pharmaceuticals, Inc.
Ms Betsy Lee, Clinical Project Manager: +1 617 352 0985
Ms Betsy Lee, Clinical Project Manager: blee@corbusphara.com
completed
Sept. 13, 2018
35
Interventional
Randomized, Parallel Assignment, Double-Blind
treatment purpose
3
Key Inclusion Criteria:
1.Greater-than or Equal to 18 years of age at the time Informed Consent is signed.
2.Diffuse cutaneous SSc (skin thickening on upper arms, upper legs, or trunk).
3.Disease duration Less-than or Equal to 6 years from the first non-Raynaud's symptom.
4.No new or increased doses of immunosuppressive medications within 8 weeks prior to Screening.
Key Exclusion Criteria:
1.Unstable SSc or SSc with end-stage organ involvement at Screening or Visit 1.
2.Any of the following values for laboratory tests at Screening:
(1)A positive pregnancy test in women of childbearing potential;
(2)Hemoglobin less-than 9 g/dL for males and less-than 8 g/dL for females;
(3)Neutrophils less-than 1.0 X 10^9/L;
(4)Platelets less-than 75 X 10^9/L;
(5)Creatinine clearance less-than 50 mL/min according to the Modification of Diet in Rena Disease (MDRD) Study equation;
(6)Aspartate aminotransferase or alanine aminotransferase Greater-than 2.0 X upper limit of normal;
3.Any medical condition 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.
18age old over
No limit
Both
Diffuse Cutaneous Systemic Sclerosis
investigational material(s)
Generic name etc : JBT-101
INN of investigational material : Lenabasum
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investigational material : JBT-101 is administrated as oral at a dose of 5 mg or ,20 mg or placebo twice a day with at least 8 hours apart between the doses.
control material(s)
Generic name etc : Placebo
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : -
safety
efficacy
Efficacy:
Efficacy of lenabasum compared to placebo for the change from baseline in modified Rodnan skin score. [ Time Frame: Change from baseline through study completion, up to 1 year. ]
mRSS evaluates a subject's skin thickness on a 4 point scale for 17 surface anatomic areas: 0 = normal skin; 1 = mild thickness; 2 = moderate thickness; 3 = severe thickness with inability to pinch skin into fold. The individual values of the 17 surface areas are summed to define the total skin score with a maximum score of 51.
Safety:
To evaluate TEAEs(Treatment-emergent adverse event) from Day 1 through Week 52.
safety
efficacy
Efficacy:
1.Efficacy of lenabasum compared to placebo for the American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis score. [ Time Frame: American College of Rheumatology Combined Response Index score through study completion, up to 1 year. ]
The ACR CRISS exponential algorithm determines the predicted probability of improvement from baseline, incorporating change in mRSS, FVC% predicted, physician and patient global assessments, and HAQ-DI. The outcome is a continuous variable between 0.0 and 1.0 (0 - 100%). A higher score indicates greater improvement.
2.Efficacy of lenabasum compared to placebo for the change from baseline in Health Assessment Questionnaire - Disability Index. [ Time Frame: Change from baseline through study completion, up to 1 year. ]
It includes 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are 2 or 3 questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). The individual scores of the eight sections are summed and divided by 8. The result is the disability index or functional disability index. A higher score indicates more functional disability.
3.Efficacy of lenabasum compared to placebo for the change from baseline in forced vital capacity. [ Time Frame: Change from baseline through study completion, up to 1 year. ]
Safety:
1. To evaluate tolerability of lenabasum treatment and placebo treatment from Day 1 through Week 52.
2. To evaluate changes in vital signs, weight, BMI, physical examinations, laboratory safety tests, ECGs, and ARCI-M(Addiction Research Center Inventory-Marijuana) questionnaire associated with lenabasum treatment and placebo treatment from Day 1 through Week 52.
3. To evaluate the minimal important difference (MID) in mRSS and CRISS.
4. To evaluate long-term signals of efficacy in an open-label extension.
Corbus Pharmaceuticals, Inc. ((EPS International Holdings Co., Ltd.; ICCC).
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Corbus Pharmaceuticals, Inc.
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Tohoku University Hospital Institutional Review Board
