Kiacta in Sarcoidosis, Part II

We are beginning a second round of input for our Kiacta in sarcoidosis project.

Sarcoidosis is a disease of unknown origin with autoimmune features that causes granulomatous inflammation. It often affects the lungs and can cause pulmonary scarring. Kiacta is a compound developed by Auven Therapeutics for AA amyloidosis and sarcoidosis. TLS is assisting Auven on the sarcoidosis aspect of the program.

We submitted a draft protocol to the FDA in June 2015. The Agency has proposed certain changes to that protocol regarding study design and endpoints. In finalizing the design for this project, we would like the crowd to give us feedback through an updated Protocol Builder.

Key areas of the trial that we are looking for feedback include:

  • Overall Trial Design

  • Adaptive Design/Interim Analysis

  • Steroid Rescue

Start Protocol Builder Now

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

Study Design


 

We are proposing significant changes to the run-in and taper periods.

What is your opinion of this new study design?

What is your opinion of this new study design?

DiscussDiscuss

Adaptive Design

How can we implement an adaptive design for this trial?

Patients will be asked about potential recruitment targets.

Please suggest novel statistical methods.

DiscussDiscuss

Steroid Rescue

Do you agree with our rescue criteria?

Patients are being asked to respond to our working rescue definition.

Researchers are being asked to respond to our working rescue definition.

DiscussDiscuss