Other Clinical Trial - Safety, Tolerability & Activity of BIVV009 in

Status Completed

Clinical Trial Summary

Prospective, double-blind, randomized, placebo-controlled First-In-Human study with four sub-parts: Part A, a single ascending dose study (SAD) in normal human volunteers (NHVs), Part B, a multiple ascending dose study (MAD) in NHVs, Part C, a multiple dose (MD) study in patients with a complement-mediated disorder, and Part E, a multiple dose (MD) study in patients with cold agglutinin disease previously treated with BIVV009 within the scope of a BIVV009 clinical trial or named patient program use. Note: For parts A-C as well as at the start of part E, study drug was named TNT009. The study drug name is changed to BIVV009 with final version Final 15.0 of the clinical study protocol.

Clinical Trial Description

Study TNT009-01 (parts A-C)/ BIVV009 (part E) is a First in Human (FIH) study that uses an Integrated Protocol Design. This Phase 1 study protocol will comprise three sub-parts: a Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) study in normal male and female human volunteers (NHVs), and a Multiple Dose (MD) study in patients with various complement-mediated disorders not confined to a single disease or therapeutic area. Although these patients represent a population with a diverse set of clinical diagnoses they are united by a common mechanism of disease matched to the mechanism of action of BIV009. Several key safety measures have been incorporated into the design of this study, including use of Sentinel Dosing Groups and an independent Data Safety Monitoring Board (DSMB), as well as an appropriate program of prophylactic vaccinations and clinical biomarker surveillance related to the risks potentially associated with inhibition of the complement system. To allow access of BIVV009 to CAD patients where successful treatment effect has been observed and to allow re-initiation of BIVV009 to previously treated CAD patients, Part E has been added to both continued access to study drug in this subset of study patients, and to further characterize the safety and efficacy to BIVV009. ;

Study Design

Related Conditions & MeSH terms

Anemia, Hemolytic
Anemia, Hemolytic, Autoimmune
Bullous Pemphigoid (BP)
Cold Agglutinin Disease (CAD)
End-stage Renal Disease (ESRD)
Kidney Failure, Chronic
Pemphigoid, Bullous
Warm Autoimmune Hemolytic Anemia (WAIHA)

Clinical Trial Details

NCT number	NCT02502903
Study type	Interventional
Source	Sanofi
Contact
Status	Completed
Phase	Phase 1
Start date	July 13, 2015
Completion date	March 31, 2021

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Safety, Tolerability and Activity of BIVV009 in Healthy Volunteers and Patients With Complement Mediated Disorders — BIVV009-01

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms