NCT02465437

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2015

Longer than P75 for phase_2

Geographic Reach
1 country

9 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 8, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 years until next milestone

Results Posted

Study results publicly available

October 2, 2018

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2020

Completed
Last Updated

April 21, 2021

Status Verified

March 1, 2021

Enrollment Period

1.2 years

First QC Date

June 4, 2015

Results QC Date

March 8, 2018

Last Update Submit

March 25, 2021

Conditions

Diffuse Cutaneous Systemic Sclerosis

Keywords

JBT-101, Lenabasum, Systemic Sclerosis

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Day 85 and Day 113

Secondary Outcomes (5)

  • CRISS Individual Components (mRSS Total Score) Change From Baseline.

    Day 85 and 113

  • CRISS Individual Component (FVC Percent Predicted) Change From Baseline

    Day 85 and 113

  • CRISS Individual Component (Physician Global Assessment Score) Change From Baseline

    Day 85 and 113

  • CRISS Individual Component (Patient Global Assessment Score) Change From Baseline

    Day 85 and 113

  • CRISS Individual Component (HAQ-DI Score) Change From Baseline.

    Day 85 and 113

Study Arms (5)

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.

Drug: JBT-101Drug: 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.

Drug: JBT-101Drug: Placebo

JBT-101 20 mg bid/20 mg bid

EXPERIMENTAL

JBT-101 20 mg bid on Days 1-84.

Drug: JBT-101

Placebo

PLACEBO COMPARATOR

Placebo bid on Days 1-84.

Drug: Placebo

Part B Open-label

EXPERIMENTAL

JBT-101 20 mg bid on Days 1-364

Drug: Part B Open-Label Extension

Interventions

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.

JBT-101 20 mg bid/20 mg bidJBT-101 20 mg/20 mg bidJBT-101 5 mg/20 mg bid
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.

JBT-101 20 mg/20 mg bidJBT-101 5 mg/20 mg bidPlacebo
Part B Open-Label ExtensionDRUG

JBT-101 20mg bid on Days 1-364

Part B Open-label

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Arthritis Association of Southern CA

Los Angeles, California, United States

Location

Stanford University

Palo Alto, California, United States

Location

John Hopkins Scleroderma Center

Baltimore, Maryland, United States

Location

Boston University Medical Center

Boston, Massachusetts, United States

Location

Rutgers University

New Brunswick, New Jersey, United States

Location

Weill Cornell Medical College

New York, New York, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Location

University of Texas Houston Medical School

Houston, Texas, United States

Location

University of Utah

Salt Lake City, Utah, United States

Location

MeSH Terms

Conditions

Scleroderma, DiffuseScleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Results Point of Contact

Title
John Skutnik, MS
Organization
Corbus Pharmaceuticals, Inc.
jskutnik@corbuspharma.com
781-562-9853

Study Officials

  • Robert Spiera, M.D.

    Weill Cornell Medical College, New York City, NY

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2015

First Posted

June 8, 2015

Study Start

August 1, 2015

Primary Completion

October 1, 2016

Study Completion

December 11, 2020

Last Updated

April 21, 2021

Results First Posted

October 2, 2018

Record last verified: 2021-03

Locations

US(9)