As many of you know, I’m not only a physician specializing in allergy, immunology, and lifestyle medicine, but also a patient living with Sjogren’s Syndrome. This chronic autoimmune disease can be incredibly challenging, bringing a constellation of symptoms like fatigue, dry mouth and eyes, and body pain.

But beyond the physical symptoms, it's the emotional toll –– the feeling of betrayal by your own body, the fear of the unknown –– that I’ve found to be the most difficult. It's something I continually work through with everything I’ve added to my toolkit over the years since diagnosis.

This search for answers and a deeper understanding of how to not only help those suffering from similar issues but for my own well-being, led me to participate in a clinical trial for Sjogren's.

The OASIZ Trial: A Glimmer of Hope

The clinical trial I joined, called OASIZ, is investigating a new medication called Dazodalibep. This drug works by blocking a molecule called CD40 ligand. CD40 ligand plays a vital role in the immune system’s communication network, especially between the “fighter” T-cells and B-cells. In Sjogren’s, this communication gets disrupted, leading to an overactive immune response. Dazodalibep aims to interrupt these faulty signals, helping calm down that overzealous immune system.

Like any patient starting a new treatment, I had questions: Is it safe? Will it even work? And like anyone stepping into the unknown, there were nerves –– this was my first time participating in a clinical trial and my first experience with regular infusions.

The Clinical Trial Process: A Behind-the-Scenes Look

The OASIZ trial is a phase 3, double-blind, placebo-controlled study. Here’s what that means:

• Phase 3: This stage involves a larger group of participants to evaluate the treatment's effectiveness and monitor for side effects. It’s usually the final stage before the FDA evaluates whether this new treatment will be approved for widespread use.

• Double-Blind: Neither the participants nor the researchers know who's receiving the actual medication and who's getting the placebo (an inactive substance, like saline). This helps eliminate bias and ensures the results are as accurate as possible.

• Placebo-Controlled: Having a “control group” (those getting the placebo) provides a vital comparison point for scientists to accurately assess if the medication itself is truly making a difference – or if it’s something else!

Getting into the trial involved several steps: contacting the study coordinator, a phone interview to go through the eligibility requirements, and a comprehensive initial visit, which included a detailed medical history, a physical exam, and a lot of lab work!

Six Months In: My Experience So Far

I’m now about six months into the year-long OASIZ trial. While I won't know for sure if I received the actual medication until the study is complete, I’ve noticed some positive changes. My energy levels have improved significantly, which is a huge win considering fatigue has always been a major challenge. I’ve even found I can leave the house occasionally without my constant companion (my water bottle!) –– those of you with Sjogren's dryness know what a victory that is! 🎉

As for side effects, the infusion itself takes about 90 minutes, plus waiting time afterward. On infusion days, I do experience some fatigue, but this is common with any infusion. I've also had mild heart palpitations, which are being closely monitored by the study team. Overall, the benefits have outweighed these minor side effects.

Even if a participant receives the placebo, many phase 3 trials offer an “open-label extension,” where everyone gets access to the medication after the initial year while the drug goes through that final FDA approval process. This offers a glimmer of hope, especially for those of us with Sjogren’s who have been waiting for new treatment options!

Why Clinical Trials Matter: Paving the Way for Progress

Clinical trials are crucial for advancing medical knowledge and discovering new, safer, and more effective treatments. They involve rigorous testing and evaluation, typically in three phases:

1. Phase 1: Small groups of people test the drug’s safety and ideal dosage.

2. Phase 2: Larger groups evaluate effectiveness and further monitor safety.

3. Phase 3: Large-scale studies confirm effectiveness, monitor side effects, and compare the drug to existing treatments (or placebo). These are the trials that provide the vital data regulators need before they can approve that treatment for use by all patients.

Considering a Clinical Trial? You Are in Control

Thinking about joining a clinical trial? Do your homework! ClinicalTrials.gov is an excellent resource for exploring studies. You can search based on your condition, location, and eligibility criteria – and it's completely your decision.

Participating in a clinical trial isn't just about potentially finding relief –– it’s about contributing to the future of medicine and providing hope for others walking a similar path.

From Patient to Physician: A Deeper Understanding

My own experience in the OASIZ trial has profoundly impacted my approach to patient care. It has deepened my empathy for those waiting for answers, navigating the complexities of the healthcare system, and those often frustrating moments when it feels like you're not being heard.

This journey has strengthened my commitment to:

• Patient-Centered Care: Listening deeply, validating experiences, and empowering patients to make informed choices.

• Creating a Supportive Environment: Understanding the emotional toll of chronic illness and offering encouragement and resources.

Let's Talk Clinical Trials & Sjogren’s

What questions do you have about clinical trials or Sjogren’s treatments? Share your experiences, your hopes, and your questions in the comments –– let’s support each other!