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

NCT02047604 | Completed Phase 2 Results DMC

• 2 other identifiers: C2013-03022013-003719-23
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 12

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).

Conditions

Rheumatoid Arthritis

Keywords

Phase 2a multiple ascending dose, Anti-Very Late Antigen-1

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  Adverse events data are collected during a 10-week period, which includes 6 weeks of treatment and 4 weeks of follow-up.

  10 weeks

Secondary Outcomes (2)

• Change From Baseline in Disease Activity Score With 28-joint Count Using C-reactive Protein (DAS28-CRP)

  Baseline, End of Treatment Visit (Week 7)

• Number of Participants With American College of Rheumatology 20 (ACR20) Response.

  End of Treatment Visit (Week 7)

Other Outcomes (2)

• Change From Baseline in the Health Assessment Questionnaire-Disease Index (HAQ-DI)

  Baseline, End of Treatment Visit (Week 7)

• Bone Erosion Detected Using Magnetic Resonance Imaging (MRI) Findings of the Hand and Wrist - Change From Baseline

  Baseline, End of Treatment Visit (Week 7)

Study Arms (6)

Cohort A - SAN-300 0.5 mg/kg QW

EXPERIMENTAL

SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks

Drug: SAN-300 0.5 mg/kg QW

Cohort B - SAN-300 1.0 mg/kg QW

EXPERIMENTAL

SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks

Drug: SAN-300 1.0 mg/kg QW

Cohort C - SAN-300 2.0 mg/kg QOW

EXPERIMENTAL

SAN-300 2.0 mg/kg subcutaneous every other week for six weeks

Drug: SAN-300 2.0 mg/kg QOW

Cohort D - SAN-300 4.0 mg/kg QOW

EXPERIMENTAL

SAN-300 4.0 mg/kg subcutaneous every other week for six weeks

Drug: SAN-300 4.0 mg/kg QOW

Cohort E - SAN-300 4.0 mg/kg QW

EXPERIMENTAL

SAN-300 4.0 mg/kg subcutaneous every other week for six weeks

Drug: SAN-300 4.0 mg/kg QW

Placebo

PLACEBO COMPARATOR

Placebo dosing

Drug: Placebo

Interventions

SAN-300 0.5 mg/kg QW DRUG

Cohort A - SAN-300 0.5 mg/kg QW

SAN-300 1.0 mg/kg QW DRUG

Cohort B - SAN-300 1.0 mg/kg QW

SAN-300 2.0 mg/kg QOW DRUG

Cohort C - SAN-300 2.0 mg/kg QOW

SAN-300 4.0 mg/kg QOW DRUG

Cohort D - SAN-300 4.0 mg/kg QOW

SAN-300 4.0 mg/kg QW DRUG

Cohort E - SAN-300 4.0 mg/kg QW

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with RA for ≥ 6 months according to American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Classification Criteria 2010
• to 75 years of age, inclusive, at the time of informed consent
• Swollen joint count of ≥ 6 (66-joint count) and tender joint count of ≥ 6 (68-joint count) at Screening and randomization
• 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)
• Stable dose of methotrexate (≥ 15 mg/week and ≤ 25 mg/week) for ≥ 6 weeks before randomization

You may not qualify if:

• Functional Class IV as defined by ACR classification of functional status in RA
• History of significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis, or Felty's syndrome)
• 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
• 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
• History of recurrent clinically significant infections
• Current active infection or serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within 3 months before randomization
• History of severe allergic or anaphylactic reactions to other biologic agents
• History of allergies to murine protein
• 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
• History of tuberculosis or latent infection currently undergoing treatment
• History of malaria
• 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
• Intra-articular corticosteroid injection(s) within 4 weeks before randomization
• Any live immunization/vaccination, including against Herpes zoster, within 4 weeks before randomization. Live vaccinations must also be avoided throughout the study
• Abnormal laboratory value at Screening or Day -1 considered clinically significant

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (12)

Santarus Clinical Investigational Site 1012

Phoenix, Arizona, 85023, United States

Location

Santarus Clinical Investigational Site 1004

El Cajon, California, 92020, United States

Location

Santarus Clinical Investigational Site 1008

Los Angeles, California, 90048, United States

Location

Santarus Clinical Investigational Site 1011

San Leandro, California, 94578, United States

Location

Santarus Clinical Investigational Site 1013

Brandon, Florida, 33511, United States

Location

Santarus Clinical Investigational Site 1003

Palm Harbor, Florida, 34684, United States

Location

Santarus Clinical Investigational Site 1017

Florissant, Missouri, 63031, United States

Location

Santarus Clinical Investigational Site 1009

Brooklyn, New York, 11201, United States

Location

Santarus Clinical Investigational Site 1019

Chapel Hill, North Carolina, 27599, United States

Location

Santarus Clinical Investigational Site 1014

Charlotte, North Carolina, 28210, United States

Location

Santarus Clinical Investigational Site 1006

Salisbury, North Carolina, 28144, United States

Location

Santarus Clinical Investigational Site 1001

Middleburg Heights, Ohio, 44130, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: VP Clinical Services
• Organization: Valeant Pharmaceuticals

christine.hnatko@valeant.com

9089271162

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: January 22, 2014
• First Posted: January 28, 2014
• Study Start: December 1, 2013
• Primary Completion: February 23, 2017
• Study Completion: March 23, 2017
• Last Updated: June 21, 2021
• Results First Posted: June 21, 2021

Record last verified: 2021-06

Locations

US (12)