Clinical Trial Trends: Rare Autoimmune

Looking at worldwide data, roughly 4.5% of the population has been diagnosed with at least one autoimmune disorder. Some estimates of the autoimmune incidence rate are even higher (up to 10%). With thousands affected by autoimmune diseases each year, this therapeutic area is a prominent focus of contemporary medical research. Autoimmune diseases are complex because many conditions share common symptoms as well as genetic factors. In addition, many people who have one autoimmune disease have more than one (called polyautoimmunity), which complicates diagnosis and treatment.  
 
While common autoimmune diseases are well known, there are numerous rare autoimmune that are equally important but less recognized. According to Grand View Research, just over 50 of the nearly 800 orphan drug candidates in 2021 were for autoimmune conditions. 

Our exploration of the rare autoimmune clinical research space will cover trial statuses, geographic and demographic distributions, and phase breakdowns. 

Understanding the Rare Autoimmune Clinical Trial Landscape  

This article delves into the intricate landscape of rare autoimmune clinical trials, equipped with data-driven insights from Citeline, to showcase current research efforts. 

Rare Autoimmune Clinical Trials by Status  

Analysis of rare autoimmune trials by status using Citeline’s Trialtrove indicates that almost 14% of the 13,019 recorded trials are active, showcasing ongoing research momentum. 

Rare Autoimmune Trials by Status 

Citeline Trialtrove^® – 28MAY2024 

Rare Autoimmune Trials by Start Date  

Yearly trends show a consistent rise in trial initiations for rare autoimmune studies, with 1500 new studies launched since 2020. 

Planned & Ongoing Rare Autoimmune Trials by Start Date 

Citeline Trialtrove^® – 28MAY2024 

Rare Autoimmune Trials by Country  

A global endeavor, rare autoimmune clinical trials are conducted in 85 countries, with the United States leading in numbers followed by significant contributions from China and France. In the countries outside of the top 15, the overall landscape is much more broad and is heavily impacted by indication. 

Planned & Ongoing Rare Autoimmune Trials by Site Country (Top 15) 

Citeline Trialtrove^® – 28MAY2024 

Rare Autoimmune Trials by Indication 

Rare autoimmune trials can take very different focuses. Issues around transplantation and/or Graft-Versus-Host-Disease (GVHD) are a frequent focus, but pulmonary fibrosis and lupus are also common indications in rare autoimmune research. 

Planned & Ongoing Rare Autoimmune Trials by Indication 

Citeline Trialtrove^® – 28MAY2024

Rare Autoimmune Trials by Phase  

Phase distribution for rare autoimmune trials is relatively balanced, with 370 Phase 1 trials and 664 Phase 2 trials currently underway compared to 317 Phase 3 trials and 447 Phase 4. 

Planned & Ongoing Rare Autoimmune Trials by Phase 

Citeline Trialtrove^® – 28MAY2024 

Precision's Expertise in Rare Autoimmune

Precision for Medicine’s expertise in rare autoimmune research includes 26 trials, serving almost 3000 patients across 1074 sites and 7 regions.  

Rare Autoimmune Trial Starts  

From 2019 to present, Precision for Medicine has expanded its research portfolio by starting 7 new trials in rare autoimmune research. 

Precision for Medicine's Rare Autoimmune Trials by Start Date 

Citeline Trialtrove^® – 28MAY2024 

Precision's Reach in Rare Autoimmune Research  

The reach of Precision for Medicine in rare autoimmune clinical trials is broad, with active sites in 44countries, from the US to Australia, each adding unique value to our research. 

Precision for Medicine's Rare Autoimmune Trials by Site Country

Citeline Trialtrove^® – 28MAY2024 

Rare Autoimmune Trials by Phase 

In rare autoimmune research, we maintain a strong presence in early phase clinical trials, with 17 studies in Phase 1, Phase 1-2, and Phase 2.  

Precision for Medicine's Rare Autoimmune Trials by Phase 

Citeline Trialtrove^® – 28MAY2024 

Precision's Experience by Indication  

Precision’s experience in rare autoimmune is diversified across indications, including some of the common areas of rare autoimmune research and more novel ones. 

Precision for Medicine's Rare Autoimmune Trials by Indication 

Chart Caption: Citeline Trialtrove^® – 28MAY2024 

The Precision Difference

Precision teams understand how to overcome the challenges in this field of research. From the inevitable small patient population and geographic dispersion to polyautoimmunity and heterogeneity within a rare disease, we are your partner for effective, efficient, and ethical rare autoimmune disease research.

We develop trial designs that sustain engagement through the length of the trial and help shepherd your drug development program beyond a single trial to support regulatory submission and approval.