Randomized, Double-blind, Vehicle Controlled, Repeat Dose Comparative Study in RA Patients Managed With DMARDs

PHASE1CompletedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

March 22, 2021

Primary Completion Date

October 12, 2021

Study Completion Date

October 12, 2021

Conditions
Rheumatoid Arthritis
Interventions
DRUG

Low dose ORTD-1

Once weekly, single subcutaneous injection of ORTD-1 at a volume of 0.45 mL. Six weekly treatments; 28-day follow-up period.

DRUG

Low dose vehicle control

Once weekly subcutaneous injection of vehicle at a volume of 0.45 mL. Six weekly treatments; 28-day follow-up period.

DRUG

High dose ORTD-1

Two subcutaneous injections of ORTD-1 at two injection sites once weekly; 0.90 mL of ORTD-1 per each subcutaneous injection. Six weekly treatments; 28-day follow-up period.

DRUG

High dose vehicle control

Two subcutaneous injections of vehicle at two injection sites once weekly; 0.90 mL of vehicle per each subcutaneous injection. Six weekly treatments; 28-day follow-up period.

Trial Locations (3)

33147

Advanced Pharma CR, LLC, Miami

90033

Keck School of Medicine of USC Division of Rheumatology, Los Angeles

92780

Orange County Research Center, Tustin

Sponsors
All Listed Sponsors
lead

Oryn Therapeutics, LLC

INDUSTRY

NCT04286789 - Randomized, Double-blind, Vehicle Controlled, Repeat Dose Comparative Study in RA Patients Managed With DMARDs | Biotech Hunter | Biotech Hunter