Kiacta in Sarcoidosis
Why Study Kiacta in Sarcoidosis?
TLS has begun a collaboration with Auven Therapeutics to develop Kiacta in sarcoidosis. Kiacta is a compound developed by Auven Therapeutics for AA amyloidosis and sarcoidosis. TLS is assisting Auven on the sarcoidosis aspect of the program.
- Sarcoidosis is a disease of unknown origin with autoimmune features that causes granulomatous inflammation. It often affects the lungs and can cause pulmonary scarring.
- The current treatments for pulmonary sarcoidosis include corticosteroids and immunomodulatory medications, which may cause severe side effects.
- Kiacta is a molecule specifically designed to inhibit amyloid deposition into tissues. It presents the opportunity for a safer treatment than corticosteroids.
An Opportunity for Publication
All participants will be able to review and comment on drafts of the protocol as they are produced, and they will be mailed a TLS Development Team membership certificate to show their support for open innovation.
Participating in the Protocol Builder also enters you into a friendly competition among the research community. When we identify the researchers who have provided the best input for a certain section of the Protocol Builder, we will name up to three winners of the section.
By winning a section, researchers will enter into a discussion with the TLS study team on how to draft the best protocol. When this protocol is published, the top researchers will have co-authorship rights and an ongoing say into the design and implementation of the trial.Protocol Builder Results
Should Kiacta be investigated for its potential ability to improve pulmonary function by inhibiting granuloma formation in sarcoidosis?
This study requires steroid run-in and tapering periods. The specifics of which need to be determined through crowd input.
We'd like patients to weigh the pros and cons of a proposed trial design.
Please respond to a specific dosage regimen for tapering patients' steroid levels.
Our propsed primary endpoint:
Absolute improvement in percent predicted FVC and/or FEV1 at 12 months compared to baseline.
Patients are being asked about their willingness to enroll in a clinical trial for Kiacta in order to estimate participation and/or dropout rates for the trial.
In this section, you can critique our plans related to statistical measures in this trials, such as the number of patients screened, number of patients enrolled, and estimated dropout rate.
We propose using telemonitoring for this study in the following ways:
- Portable Spirometry – forced vital capacity and forced expiratory volume
- Vital signs - blood pressure, pulse, respirations
- Pulse oximetry - O2 saturation
- Body weight, height
- Medication monitoring
- Diffusing capacity of lung for carbon monoxide (DLCO)
- Six Minute Walk test
- Video Visits