(C2013-0302) Safety and Efficacy of Escalating Doses of SAN-300 in Patients With Rheumatoid Arthritis

Phase 2

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: SAN-300 2.0 mg/kg QOW; Drug: Placebo; Drug: SAN-300 0.5 mg/kg QW; Drug: SAN-300 1.0 mg/kg QW; Drug: SAN-300 4.0 mg/kg QOW; Drug: SAN-300 4.0 mg/kg QW

• Registration Number: NCT02047604
• Lead Sponsor: Bausch Health Americas, Inc.

Brief Summary

A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Escalating Doses of SAN-300 in Patients with Active Rheumatoid Arthritis with Inadequate Response to Disease-Modifying Anti-rheumatic Drug(s).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-01-22
• Study First Submitted QC: 2014-01-24
• Study First Posted: 2014-01-28
• Primary Completion: 2017-02-23
• Study Completion: 2017-03-23
• Results First Submitted: 2018-04-05
• Status Verified: 2021-06
• Results First Submitted QC: 2021-06-18
• Last Update Submitted: 2021-06-18
• Results First Posted: 2021-06-21
• Last Update Posted: 2021-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

1. Diagnosed with RA for ≥ 6 months according to American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Classification Criteria 2010
2. 18 to 75 years of age, inclusive, at the time of informed consent
3. Swollen joint count of ≥ 6 (66-joint count) and tender joint count of ≥ 6 (68-joint count) at Screening and randomization
4. Inadequate response to therapy or discontinuation of therapy because of unacceptable toxicity from at least one prior traditional or biologic disease-modifying anti-rheumatic drug (DMARD)
5. Stable dose of methotrexate (≥ 15 mg/week and ≤ 25 mg/week) for ≥ 6 weeks before randomization

Exclusion Criteria

1. Functional Class IV as defined by ACR classification of functional status in RA
2. History of significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis, or Felty's syndrome)
3. History of malignancy or carcinoma in situ within the 5 years before Screening or any history of melanoma. Patients with history of excised or adequately treated non-melanoma skin cancer are eligible
4. Evidence of clinically significant uncontrolled concurrent diseases such as cardiovascular, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major diseases
5. History of recurrent clinically significant infections
6. Current active infection or serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within 3 months before randomization
7. History of severe allergic or anaphylactic reactions to other biologic agents
8. History of allergies to murine protein
9. Surgery within 3 months before randomization (other than minor cosmetic surgery or minor dental procedures) or plans for a surgical procedure during the Treatment Period or Follow-up Period
10. History of tuberculosis or latent infection currently undergoing treatment
11. History of malaria
12. Treatment regimen with prednisone that is either over 10 mg/day (or equivalent dose of another corticosteroid) or is not taken at a stable dose of ≤ 10 mg/day for at least 4 weeks before randomization
13. Intra-articular corticosteroid injection(s) within 4 weeks before randomization
14. Any live immunization/vaccination, including against Herpes zoster, within 4 weeks before randomization. Live vaccinations must also be avoided throughout the study
15. Abnormal laboratory value at Screening or Day -1 considered clinically significant
16. Positive for hepatitis C virus (HCV) antibody or hepatitis B surface antigen (HBsAg)
17. Positive for human immunodeficiency virus (HIV) antibody
18. History of tuberculosis or positive QuantiFERON®-TB Gold test (QFT)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort C - SAN-300 2.0 mg/kg QOW	SAN-300 2.0 mg/kg QOW	SAN-300 2.0 mg/kg subcutaneous every other week for six weeks
Placebo	Placebo	Placebo dosing
Cohort A - SAN-300 0.5 mg/kg QW	SAN-300 0.5 mg/kg QW	SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks
Cohort B - SAN-300 1.0 mg/kg QW	SAN-300 1.0 mg/kg QW	SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks
Cohort D - SAN-300 4.0 mg/kg QOW	SAN-300 4.0 mg/kg QOW	SAN-300 4.0 mg/kg subcutaneous every other week for six weeks
Cohort E - SAN-300 4.0 mg/kg QW	SAN-300 4.0 mg/kg QW	SAN-300 4.0 mg/kg subcutaneous every other week for six weeks

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	10 weeks	Adverse events data are collected during a 10-week period, which includes 6 weeks of treatment and 4 weeks of follow-up.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With American College of Rheumatology 20 (ACR20) Response.	End of Treatment Visit (Week 7)	A participant is considered to have an ACR20 response if there is an improvement of 20% in all of the following: * Swollen joint count (66 joints); * Tender joint count (68 joints) and; * At least three of the following five assessments: * Patient's assessment of pain; * Patient's global assessment of disease activity; * Physician's global assessment of disease activity; * Patient's assessment of physical function, as measured by the HAQ-DI; * CRP
Change From Baseline in Disease Activity Score With 28-joint Count Using C-reactive Protein (DAS28-CRP)	Baseline, End of Treatment Visit (Week 7)	DAS28-CRP= 0.56 x sqrt(TJC28) x sqrt(SJC28) + 0.36 x ln(CRP+1) +0.014 x VAS +0.96 Where TJC28: The number of tender joints (0-28). SJC28: The number of swollen joints (0-28). CRP: The C-Reactive Protein level (in mg/l). VAS General Health Assessment (from 0=best to 100=worst). ln=natural log. sqrt = square root. Higher scores indicate worse outcome.

Trial Locations

Locations (12)

Santarus Clinical Investigational Site 1012; 🇺🇸 Phoenix, Arizona, United States

Santarus Clinical Investigational Site 1004; 🇺🇸 El Cajon, California, United States

Santarus Clinical Investigational Site 1011; 🇺🇸 San Leandro, California, United States

Santarus Clinical Investigational Site 1008; 🇺🇸 Los Angeles, California, United States

Santarus Clinical Investigational Site 1013; 🇺🇸 Brandon, Florida, United States

Santarus Clinical Investigational Site 1003; 🇺🇸 Palm Harbor, Florida, United States

Santarus Clinical Investigational Site 1019; 🇺🇸 Chapel Hill, North Carolina, United States

Santarus Clinical Investigational Site 1017; 🇺🇸 Florissant, Missouri, United States

Santarus Clinical Investigational Site 1006; 🇺🇸 Salisbury, North Carolina, United States

Santarus Clinical Investigational Site 1014; 🇺🇸 Charlotte, North Carolina, United States

Santarus Clinical Investigational Site 1009; 🇺🇸 Brooklyn, New York, United States

Santarus Clinical Investigational Site 1001; 🇺🇸 Middleburg Heights, Ohio, United States