1402
What is the injection time for our new autoinjector?
Approximately 15 seconds
Can the screening period of the 1402 trial be extended? If so, how long?
This period of the CLE trial may be extended by 2 weeks.
What is the duration of treatment Periods 1 and 2 on the Graves' Disease protocol?
26 weeks each for a total of 52 weeks
What are three options for patient dosing on the RA protocol?
In clinic, self-administration and home health vendors.
What are the preferable injection sites for 1402?
Abdominal quadrant, upper arm and thigh, right or left side of the body
What periods in the CLE trial are blinded to treatment assignment?
Period 1 and Period 3.
What types of drugs on the Graves' Disease protocol are Methimazole, carbimozole and propylthiouracil?
These are ATDs.
What is the observation time after the injection on the first two visits in the RA protocol?
30 minutes.
How does 1402 act upon IgG?
1402 blocks recycling of this substance and promotes its removal and degradation.
What three things that can be repeated once during the Screening Period?
Laboratory values, vital signs and ECGs.
During the proof of concept study for Graves' Disease, what was the noticeable finding at Week 12?
The timepoint by which most patients were off ATDs during the proof of concept study.
What optional procedure on the RA protocol may the patient also consent to?
Genetic testing.
What are characteristics of 1402 that have not been seen with other anti-FcRns?
Deep IgG lowering, favorable analyte profile and convenient administration
What is the value for the CLASE-A score at Screening and Day 1 if subject has alopecia or mucus membrane lesions?
The CLASE-A score must be >10 at Screening and Day if subject has alopecia or mucus membrane lesions.
In the proof of concept study, which important disease marker levels declined through Week 12?
TSHR autoantibody levels.
What is the primary study endpoint at Week 28 for the RA protocol?
ACR20 response.
What is the location on the FcRn molecule of the binding site for 1402?
The right side or opposite side from albumin.
When is the SLEDAI-2K score utilized and for which patients?
This assessment is required only for participants with SLE at baseline.
What does Lid Aperture measure?
The distance between the upper and lower eyelid.
What is the meaning for the term ACPA in the RA protocol?
Anti-citrullinated protein antibodies.