JBT-101 in Systemic Lupus Erythematosus (SLE)

• Register: ClinicalTrials.gov
• Last refreshed on: 17 August 2021
• Main ID: NCT03093402
• Date of registration: 21/02/2017
• Prospective Registration: Yes
• Primary sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Public title: JBT-101 in Systemic Lupus Erythematosus (SLE)
• Scientific title: A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Efficacy, Safety, and Tolerability of JBT-101 in Systemic Lupus Erythematosus
• Date of first enrolment: December 21, 2017
• Target sample size: 109
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03093402
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Meggan Mackay, M.D., M.S.
• Affiliation: The Feinstein Institute for Medical Research

• Name: Robert B. Zurier, M.D.
• Affiliation: The Feinstein Institute for Medical Research

Key inclusion & exclusion criteria

Inclusion Criteria:

- Fulfills the updated American College of Rheumatology (ACR) 1982 Revised Criteria for
the Classification of Systemic Lupus Erythematosus;

- At least 3 months of treatment with an anti-malarial drug such as hydroxychloroquine
or a history of intolerance, contraindication, or unwillingness to take an
anti-malarial drug;

- Meets the Safety of Estrogen in Lupus: National Assessment (SELENA) Systemic Lupus
Erythematosus Disease Activity Index (SLEDAI) definition of arthritis (Petri et al.,
1999) or mild/moderate arthritis or tendonitis scored as a BILAG B on the updated
BILAG 2004;

- Seven-day average of maximum of daily pain Numerical Rating Scale (NRS) scores = 4 out
of 10;

- Overlap with polymyositis, systemic sclerosis, Sjögren's syndrome, or rheumatoid
arthritis is allowed, if, in the site investigator's judgment, the predominant
clinical features are those of Systemic Lupus Erythematosus (SLE);

- Not expected by the site investigator to require a change in potential disease-
modifying treatments for SLE from Screening through Visit 6 (Day 112);

- Willing to not start nor stop any Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or
potential disease-modifying medications or supplements for SLE from Screening through
Visit 6 (Day 112), unless a change is recommended by the site investigator or other
treating physicians;

- Willing not to use any legal or illegal cannabinoids, including Food and Drug
Administration (FDA)-approved cannabinoids or cannabinoid-mimic drugs, or any illegal
substance of abuse from Screening through Visit 6 (Day 112);

- If a woman of child-bearing potential, willing to use one of the highly effective
(failure rate < 1% per year) birth control method from Screening through Visit 6 (Day
112) or for 28 ± 3 days after the last dose of study product; and

- Willing to follow instructions, complete study procedures and attend study visits as
required by this protocol.

Exclusion Criteria:

- Severe or unstable Systemic lupus erythematosus (SLE), such as any one of the
following:

- A British Isles Lupus Activity Group (BILAG) A score in one or more BILAG domains
at Screening;

- Treatment with any intraarticular, intravenous, or intramuscular systemic
corticosteroids within 14 days of Screening;

- Treatment with oral prednisone > 10 mg per day or > 20 mg every other day (or
equivalent dose of another corticosteroid) within 14 days of Screening;

- Increased dose of systemic corticosteroids in the 14 days prior to Screening;

- Treatment with cyclophosphamide or anti-TNFalpha biologic agents within 3 months
before Visit 1 (Day 1);

- Treatment with B cell-depleting monoclonal antibodies (rituximab, Ocrelizumab,
anti-CD22) within 6 months before Visit 1 (Day 1);

- Treatment with methotrexate, mycophenolate, azathioprine, leflunomide,
cyclosporine, belimumab, tacrolimus, or any other immunosuppressive agent not
included in 2b.-d. above, when the dose of that immunosuppressive agent has
increased within 3 months before Visit 1. Concurrent treatment with any of these
medications is allowed as long as the doses have been stable for at least 3
months before Visit 1 (Day 1); or

- Actively listed on an organ transplantation list or have received an organ
transplant other than a corneal transplant.

- Significant diseases or conditions other than SLE that may influence response to the
study product or safety, such as:

- Active bacterial or viral infection requiring systemic antibiotic or anti-viral
treatment within 14 days before Visit 1 (Day 1);

- Acute or chronic hepatitis B or C infection;

- Human immunodeficiency infection (HIV);

- History of active tuberculosis or positive tuberculosis skin or blood test
without: 1) completing a course of appropriate treatment; or ) having received at
least one month of appropriate treatment prior to Visit 1 (Day 1) and continuing
to receive appropriate treatment during the study;

- No elective surgery should be planned from Visit 1 (Day 1) through Visit 6 (Day
112); or

- A history of cancer except basal cell carcinoma or in situ carcinoma of the
cervix treated with apparent success with curative therapy greater than one year
before Visit 1 (Day 1).

- Significant heart disease as defined by:

- Uncontrollable congestive heart failure, unstable angina, unstable
atherosclerotic cardiovascular disease, significant arrhythmia requiring
chronic therapy, pulmonary arterial hypertension with dyspnea, disability
rated as New York heart Association Grade III or higher, severe systemic
hypertension or severe peripheral vascular disease;

- Marked baseline prolongation of QT/QTc interval (i.e. repeated demonstration
of a QTc interval = 450 msec for males and =470 msec for females);

- History of risk factors for torsade de pointes (e.g., heart failure,
hypokalemia, family history of long QT/QTc syndrome); or

- Clinically significant confirmed abnormality, as determined by the site
investigator or qualified designee, on 12-lead Electrocardiogram (ECG) at
Screening or Visit 1 (Day 1) before dosing.

- History of chronic pain requiring treatment with narcotic analgesia for more than 14
days total within 6 months of baseline. This does not include self-limited pain
associated with identifiable events such as surgery;

- Current evidence of alcohol abuse (defined as 4 or more drinks per day on at least 4
days of the week) or history of abuse of illegal and/or legally prescribed drugs such
as barbiturates, benzodiazepines, amphetamines, cocaine, or opioids during the 1 year
prior to Screening;

- Currently pregnant, breast-feeding, or lactating;

- Any investigational agent within 30 days or five therapeutic half-lives of that agent
whichever is longer, before Visit 1 (Day 1);

- Any of the following values for laboratory tests at Screening:

- A positive pregnancy test (also at Visit 1);

- A newly positive QuantiFERON(R) blood test for tuberculosis, without: 1)
completing a course of appropriate treatment; or ) having received at least one
mo


Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Lupus

SLE

Intervention(s)

Drug: Placebo

Drug: JBT-101

Primary Outcome(s)

Change from Baseline in the 7-Day Average of the Maximum Daily NRS-Pain Score at Day 84 [Time Frame: Baseline (Day 1), Day 84 (Visit 5, Last Day of Treatment)]

Secondary Outcome(s)

Change from Baseline in Lupus Disease Activity - Total BILAG-2004 Score [Time Frame: Visit 1 (Baseline, Day 1), Visit 3 (Day 28), Visit 4 (Day 56), Visit 5 (Day 84 - Last Day of Treatment) and Visit 6 (Day 112)]

Change from Baseline in Lupus Disease Activity- Patient Global Assessment Score [Time Frame: Visit 1 (Baseline, Day 1), Visit 3 (Day 28), Visit 4 (Day 56), Visit 5 (Day 84 - Last Day of Treatment) and Visit 6 (Day 112)]

Change from Baseline in State of Health- PROMIS-29 Short Form Score [Time Frame: Visit 1 (Baseline, Day 1), Visit 3 (Day 28), Visit 4 (Day 56), Visit 5 (Day 84 - Last Day of Treatment) and Visit 6 (Day 112)]

Change from Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits [Time Frame: Visit 1 (Baseline, Day 1), Visit 3 (Day 28), Visit 4 (Day 56), Visit 5 (Day 84 - Last Day of Treatment) and Visit 6 (Day 112)]

Change from Baseline in Swollen Joint Count [Time Frame: Baseline, (Day 1), Visit 3 (Day 28), Visit 4 (Day 56), Visit 5 (Day 84 - Last Day of Treatment) and Visit 6 (Day 112)]

Change from Baseline in Tender Joint Count [Time Frame: Baseline, (Day 1), Visit 3 (Day 28), Visit 4 (Day 56), Visit 5 (Day 84 - Last Day of Treatment) and Visit 6 (Day 112)]

Change from Baseline in Lupus Disease Activity -Physician's Global Assessment (PGA) Score [Time Frame: Visit 1 (Baseline, Day 1), Visit 3 (Day 28), Visit 4 (Day 56), Visit 5 (Day 84 - Last Day of Treatment) and Visit 6 (Day 112)]

Change from Baseline in Active Musculoskeletal Disease Defined by the Presence or Absence of Arthritis Using the SELENA-SLEDAI [Time Frame: Baseline (Day 1-prior to treatment initiation), Visit 3 (Day 28), Visit 4 (Day 56), Visit 5 (Day 84 - Last Day of Treatment) and Visit 6 (Day 112)]

Change from Baseline in Active Lupus Musculoskeletal Disease Activity - BILAG-2004 [Time Frame: Visit 1 (Baseline, Day 1), Visit 3 (Day 28), Visit 4 (Day 56), Visit 5 (Day 84 - Last Day of Treatment) and Visit 6 (Day 112)]

Change from Baseline in Disease Activity Using the SLE Responder Index (SRI) [Time Frame: (Baseline, Day 1-prior to treatment initiation), Visit 3 (Day 28), Visit 4 (Day 56), Visit 5 (Day 84 - Last Day of Treatment) and Visit 6 (Day 112)]

Number of Grade 3 or Higher Treatment-emergent Adverse Events (TEAS) During Treatment Phase of Study [Time Frame: Day 1 after initiation of study intervention through Day 112]

Change from Baseline in Lupus Disease Activity - SELENA-SLEDAI Score [Time Frame: Visit 1 (Baseline, Day 1), Visit 3 (Day 28), Visit 4 (Day 56), Visit 5 (Day 84 - Last Day of Treatment) and Visit 6 (Day 112)]

Change from Baseline in State of Health -PROMIS-Applied Cognition General Concerns Score [Time Frame: Visit 1 (Baseline, Day 1), Visit 3 (Day 28), Visit 4 (Day 56), Visit 5 (Day 84 - Last Day of Treatment) and Visit 6 (Day 112)]]

SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) [Time Frame: Baseline, (Day 1), Visit 3 (Day 28), Visit 4 (Day 56), Visit 5 (Day 84 - Last Day of Treatment) and Visit 6 (Day 112)]

Treatment Satisfaction After Twelve Weeks of Assigned Treatment [Time Frame: Visit 5 (Day 84 - Last Day of Treatment)]

Secondary ID(s)

DAIT ALE09

UM1AI110494

NIAID CRMS ID#: 30147

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Rho Federal Systems Division, Inc.

Autoimmunity Centers of Excellence

Corbus Pharmaceuticals Inc.