Diffuse Cutaneous Systemic SclerosisPhase 2NCT02465437
Safety, Tolerability, Efficacy, and Pharmacokinetics of JBT-101 in Systemic Sclerosis
A Phase 2 study testing JBT-101 and Part B Open-Label Extension in people with Diffuse Cutaneous Systemic Sclerosis, run by Corbus Pharmaceuticals Inc. at 9 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of JBT-101 in adult subjects with diffuse cutaneous systemic sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diffuse Cutaneous Systemic Sclerosis
- What is being tested?
- JBT-101 and Part B Open-Label Extension
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 9 sitesUnited States
- Study dates
- Aug 2015to 11 Dec 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Part A
- Diffuse cutaneous systemic sclerosis
- Have skin thickening from SSc in a body area suitable for repeat biopsy
- Disease duration ≤ 3 years from the first non-Raynaud's phenomenon or >3 years and ≤ 6 years from the first non-Raynaud's phenomenon and high sensitivity C-reactive protein > 3 mg/L, high sensitivity interleukin-6 > 5 pg/mL, or increase in mRSS ≥ 5 points over the last 6 months with total RSS ≥ 12.
- Stable treatment for SSc for at least 28 days before Visit 1
- Part B
- •Completion of dosing in Part A without permanent discontinuation of study product because of safety or tolerability reasons.
Who cannot join
- Severe or unstable systemic sclerosis
- Significant diseases or conditions other than systemic sclerosis that may influence response to the study product or safety;
- Any one of the following values for laboratory tests at Screening:
- A positive pregnancy test (or at Visit 1);
- Hemoglobin < 10 g/dL
- Neutrophils < 1.0 x 10^9/L
Show all 11Show fewer
- Platelets < 75 x 10^9/L
- Creatinine clearance < 50 ml/min according to modified Cockcroft-Gault equation
- Serum transaminases > 2.0 x upper normal limit
- Total bilirubin ≥ 1.5 x upper limit of normal
- Any other condition that, in the opinion of the Principal Investigator, is clinically significant and may put the subject at greater safety risk, influence response to study product, or interfere with study assessments.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
John Hopkins Scleroderma Center
Baltimore, Maryland
Boston University Medical Center
Boston, Massachusetts
University of Texas Houston Medical School
Houston, Texas
Arthritis Association of Southern CA
Los Angeles, California
Rutgers University
New Brunswick, New Jersey
Weill Cornell Medical College
New York, New York
Stanford University
Palo Alto, California
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania
University of Utah
Salt Lake City, Utah
About this study
Official title: A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Efficacy, and Pharmacokinetics of JBT-101 in Diffuse Cutaneous Systemic Sclerosis
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of JBT-101 in adult subjects with diffuse cutaneous systemic sclerosis.
Read the detailed description
Part A of the study is an interventional, double-blind, randomized, placebo-control design will be used to test safety, tolerability, pharmacokinetics, and efficacy of JBT-101 in subjects ≥ 18 and ≤ 70 years of age with active diffuse cutaneous systemic sclerosis. The screening period is up to 28 days, with 84 days treatment period and 28 days follow-up off active treatment.
Part B of the study is an interventional, open-label design will be used. All subjects who complete dosing in Part A without permanent discontinuation of study drug and who pass repeat safety screening will be eligible for enrollment. The screening period is up to 28 days, with a 364 day treatment period and 28 day follow up after last dose of JBT-101.
- Conditions
- Diffuse Cutaneous Systemic Sclerosis
- Being tested
- JBT-101, Placebo, Part B Open-Label Extension
- Keywords
- JBT-101, Lenabasum, Systemic Sclerosis
- Medical subject headings
- Scleroderma, Diffuse, Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JBT-101Drug
JBT-101 5 mg q am, 20 mg q am, or 20 mg bid on Days 1-28. JBT-101 20 mg bid on Days 29-84.
PlaceboDrug
Placebo q pm (with JBT-101 5 or 20 mg q AM) or placebo bid on Days 1-28. Placebo bid on Days 29-84.
Part B Open-Label ExtensionDrug
JBT-101 20mg bid on Days 1-364
| Study group | Role | What they receive |
|---|---|---|
| JBT-101 5 mg/20 mg bid | Experimental | JBT-101 5 mg q am and placebo q pm on Days 1-28, then JBT-101 20 mg twice a day (bid) on Days 29-84. Receives: Drug: JBT-101; Drug: Placebo |
| JBT-101 20 mg/20 mg bid | Experimental | JBT-101 20 mg q am and placebo q pm on Days 1-28, then JBT-101 20 mg bid on Days 29-84. Receives: Drug: JBT-101; Drug: Placebo |
| JBT-101 20 mg bid/20 mg bid | Experimental | JBT-101 20 mg bid on Days 1-84. Receives: Drug: JBT-101 |
| Placebo | Placebo comparator | Placebo bid on Days 1-84. Receives: Drug: Placebo |
| Part B Open-label | Experimental | JBT-101 20 mg bid on Days 1-364 Receives: Drug: Part B Open-Label Extension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events From Baseline at Day 113
The overall number of subjects with TEAE's per treatment group during active dosing (Days 1-84) plus the 28 day follow-up.
Measured: Part A: Day 113
Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (CRISS) at Day 85 and 113
CRISS components included the following domains: modified Rodnan skin score, forced vital capacity percent predicted, Physician Global Assessment, Patient Global Assessment, and Health Assessment Questionnaire Disability-Index. An algorithm determines the predicted probability of improvement from baseline by incorporating change in the mRSS, FVC percent predicted, Physician and Patient Global Assessments, and HAQ-DI. The outcome is a continuous variable between 0.0 and 1.0 (0 - 100%). A cut-off at 0.6 in the predicted probability of being improved has yielded the smallest misclassification error. Subjects are not considered improved if, between Visit 1 and 6, they develop new: 1) renal crisis; 2) decline in FVC% predicted by 15% (relative) from baseline and confirmed after 1 month; or 3) left ventricular failure (systolic ejection fraction < 45%) or pulmonary artery hypertension. Higher CRISS scores indicates improvement.
Measured: Day 85 and Day 113
Secondary outcomes (5)
CRISS Individual Components (mRSS Total Score) Change From Baseline.
The LS mean change from baseline (CFB) at Visit 5 (Day 85) and 6 (Day 113) is provided for mRSS total score. Change from Change from Baseline was calculated as Visit 5 - Baseline and independently Visit 6 - Baseline. The mRSS consists of an evaluation of patient's skin thickness rated by clinical palpation using a 0-3 scale (0 = normal skin; 1 = mild thickness; 2 = moderate thickness; 3 = severe thickness with inability to pinch the skin into a fold for each of 17 surface anatomic areas of the body: face, anterior chest, abdomen, and, with right and left sides of the body separately evaluated, the fingers, forearms, upper arms, thighs, lower legs, dorsum of hands and feet. Individual values are summed and defined as the total skin score. Total score is 0 to 51 with higher scores indicating worse symptomology
Measured: Day 85 and 113
CRISS Individual Component (FVC Percent Predicted) Change From Baseline
The LS mean change from baseline (CFB) at Visit 5 (Day 85) and 6 (Day 113) is provided for FVC percent predicted. Change from Baseline was calculated as Visit 5 - Baseline and independently Visit 6 - Baseline.
Measured: Day 85 and 113
CRISS Individual Component (Physician Global Assessment Score) Change From Baseline
The LS mean change from baseline (CFB) at Visit 5 (Day 85) and 6 (Day 113) is provided for physician global assessment. Change from Baseline was calculated as Visit 5 - Baseline and independently Visit 6 - Baseline. The Physician Global Assessment of disease activity will be performed using a segmented numerical version of the visual analogue scale in which the physician selects a whole number (0-10 integers) that best reflects the overall disease activity. The numerical rating score is anchored by 2 verbal descriptors, one of "no disease activity" (score of 0) and one of "worse imaginable disease activity" (score of 10), with numbers 1-9 spaced equidistance in between. The physician will select an integer to describe disease activity. The recall period is one week.
Measured: Day 85 and 113
CRISS Individual Component (Patient Global Assessment Score) Change From Baseline
The LS mean change from baseline (CFB) at Visit 5 (Day 85) and 6 (Day 113) is provided for patient global assessment. Change from Baseline was calculated as Visit 5 - Baseline and independently Visit 6 - Baseline. The assessment at each specified visit will be performed with a segmented numerical version of the visual analogue scale in which the subject selects a whole number (0-10 integers) that best reflects the overall disease activity. The numerical rating score is anchored by two verbal descriptors, one of "no disease activity" (score of 0) and one of "worse imaginable disease activity" (score of 10), with numbers 1-9 spaced equidistance in between. The subject will select an integer to describe disease activity. The recall period is one week.
Measured: Day 85 and 113
CRISS Individual Component (HAQ-DI Score) Change From Baseline.
Change from Baseline was calculated as Visit 5 - Baseline and independently Visit 6 - Baseline. Health Assessment Questionnaire - Disability Index includes 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are two or three questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). The eight scores of the eight sections are summed and divided by 8. If one section is not completed by a subject, the summed score is divided by 7. As such, maximum scores can vary with a min of 0. The result is the DI, the disability index or functional disability index. Higher scores indicate worse symptomology
Measured: Day 85 and 113
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startAug 2015
- Primary completionOct 2016
- Study completion11 Dec 2020
Why it stopped: Sponsor terminated open-label extension
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diffuse Cutaneous Systemic SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corbus Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Spiera, M.D., Principal investigator, Weill Cornell Medical College, New York City, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02465437
- Sponsor's protocol ID
- JBT101-SSc-001
- Status last verified
- Mar 2021
- First submitted
- 4 Jun 2015
- Last updated
- 21 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Efficacy, and Pharmacokinetics of JBT-101 in Diffuse Cutaneous Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT02465437
- Acronym / sponsor ID
- JBT101-SSc-001
- Conditions
- Diffuse Cutaneous Systemic Sclerosis
- Keywords
- JBT-101, Lenabasum, Systemic Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor terminated open-label extension
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Corbus Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- 11 Dec 2020 (actual)
- First posted
- 8 Jun 2015 (estimated)
- Results
- Posted 2 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of JBT-101 in adult subjects with diffuse cutaneous systemic sclerosis.
Detailed description
Part A of the study is an interventional, double-blind, randomized, placebo-control design will be used to test safety, tolerability, pharmacokinetics, and efficacy of JBT-101 in subjects ≥ 18 and ≤ 70 years of age with active diffuse cutaneous systemic sclerosis. The screening period is up to 28 days, with 84 days treatment period and 28 days follow-up off active treatment.
Part B of the study is an interventional, open-label design will be used. All subjects who complete dosing in Part A without permanent discontinuation of study drug and who pass repeat safety screening will be eligible for enrollment. The screening period is up to 28 days, with a 364 day treatment period and 28 day follow up after last dose of JBT-101.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| JBT-101 5 mg/20 mg bid | Experimental | Drug: JBT-101, Drug: PlaceboJBT-101 5 mg q am and placebo q pm on Days 1-28, then JBT-101 20 mg twice a day (bid) on Days 29-84. |
| JBT-101 20 mg/20 mg bid | Experimental | Drug: JBT-101, Drug: PlaceboJBT-101 20 mg q am and placebo q pm on Days 1-28, then JBT-101 20 mg bid on Days 29-84. |
| JBT-101 20 mg bid/20 mg bid | Experimental | Drug: JBT-101JBT-101 20 mg bid on Days 1-84. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo bid on Days 1-84. |
| Part B Open-label | Experimental | Drug: Part B Open-Label ExtensionJBT-101 20 mg bid on Days 1-364 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Part A
- Diffuse cutaneous systemic sclerosis
- Have skin thickening from SSc in a body area suitable for repeat biopsy
- Disease duration ≤ 3 years from the first non-Raynaud's phenomenon or >3 years and ≤ 6 years from the first non-Raynaud's phenomenon and high sensitivity C-reactive protein > 3 mg/L, high sensitivity interleukin-6 > 5 pg/mL, or increase in mRSS ≥ 5 points over the last 6 months with total RSS ≥ 12.
- Stable treatment for SSc for at least 28 days before Visit 1
Key exclusion criteria (11 listed)
- Severe or unstable systemic sclerosis
- Significant diseases or conditions other than systemic sclerosis that may influence response to the study product or safety;
- Any one of the following values for laboratory tests at Screening:
- Any other condition that, in the opinion of the Principal Investigator, is clinically significant and may put the subject at greater safety risk, influence response to study product, or interfere with study assessments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JBT-101JBT-101 5 mg q am, 20 mg q am, or 20 mg bid on Days 1-28. JBT-101 20 mg bid on Days 29-84. | Drug | JBT-101 20 mg bid/20 mg bid, JBT-101 20 mg/20 mg bid, JBT-101 5 mg/20 mg bid |
| PlaceboPlacebo q pm (with JBT-101 5 or 20 mg q AM) or placebo bid on Days 1-28. Placebo bid on Days 29-84. | Drug | JBT-101 20 mg/20 mg bid, JBT-101 5 mg/20 mg bid, Placebo |
| Part B Open-Label ExtensionJBT-101 20mg bid on Days 1-364 | Drug | Part B Open-label |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events From Baseline at Day 113
Time frame: Part A: Day 113
The overall number of subjects with TEAE's per treatment group during active dosing (Days 1-84) plus the 28 day follow-up.
Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (CRISS) at Day 85 and 113
Time frame: Day 85 and Day 113
CRISS components included the following domains: modified Rodnan skin score, forced vital capacity percent predicted, Physician Global Assessment, Patient Global Assessment, and Health Assessment Questionnaire Disability-Index. An algorithm determines the predicted probability of improvement from baseline by incorporating change in the mRSS, FVC percent predicted, Physician and Patient Global Assessments, and HAQ-DI. The outcome is a continuous variable between 0.0 and 1.0 (0 - 100%). A cut-off at 0.6 in the predicted probability of being improved has yielded the smallest misclassification error. Subjects are not considered improved if, between Visit 1 and 6, they develop new: 1) renal crisis; 2) decline in FVC% predicted by 15% (relative) from baseline and confirmed after 1 month; or 3) left ventricular failure (systolic ejection fraction < 45%) or pulmonary artery hypertension. Higher CRISS scores indicates improvement.
5 secondary outcomes
CRISS Individual Components (mRSS Total Score) Change From Baseline.
Time frame: Day 85 and 113
CRISS Individual Component (FVC Percent Predicted) Change From Baseline
Time frame: Day 85 and 113
CRISS Individual Component (Physician Global Assessment Score) Change From Baseline
Time frame: Day 85 and 113
CRISS Individual Component (Patient Global Assessment Score) Change From Baseline
Time frame: Day 85 and 113
CRISS Individual Component (HAQ-DI Score) Change From Baseline.
Time frame: Day 85 and 113
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Spiera, M.D. principal investigator
Weill Cornell Medical College, New York City, NY
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JBT-101 and Part B Open-Label Extension in people with Diffuse Cutaneous Systemic Sclerosis, run by Corbus Pharmaceuticals Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-emergent Adverse Events From Baseline at Day 113 (time frame: Part A: Day 113). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2021.