Two Years in a Sjögren's Disease Clinical Trial: My Honest Update
As a physician who also lives with Sjögren's disease, I sat down in an infusion chair to receive an experimental drug, because right now, that is what the options look like for this condition.
I have spent years sitting across from patients and telling them what their options are. Two years ago, I sat down in the infusion chair myself and received an experimental drug for my own Sjögren's disease. That is not a contradiction. It is the honest reality of where treatment for this condition stands today.
This month marks two years since I enrolled in a Phase 3 clinical trial for Sjögren's disease. I want to tell you what that has actually been like: what the drug is, how the trial was built, what I have honestly experienced, and what the broader pipeline looks like right now. If you have a friend or family member who was recently diagnosed and keeps asking what is being done about Sjögren's, this is the piece to send them. The honest answer is more hopeful than it has ever been.
A note before we start: this is education, not medical advice for your individual situation. I am aiming to be your favorite doctor on the internet, not your doctor.
There Is Still No Approved Drug for Sjögren's Disease
I want to start here, because it does not get said plainly enough. As of right now, there is no medication approved specifically for Sjögren's disease in the United States. Not for the fatigue. Not for the pain. Not for the systemic immune dysregulation driving all of it. Not for the neurologic symptoms.
What we have instead are medications borrowed from other conditions. Hydroxychloroquine was originally a malaria drug and is used widely in lupus. Rituximab was designed for certain cancers and later found to help in autoimmune disease. We reach for them in Sjögren's disease because we do not have much else, not because we have strong trial data showing they work for this specific disease process. That is the landscape I practice in, and the one I live in as a patient. I am on hydroxychloroquine too.
Sjögren's disease is not rare. It is one of the most common autoimmune diseases and, by some estimates, affects about 1 in 50 women, yet it remains one of the least talked about.
Why I Said Yes to a Clinical Trial
When the opportunity came up to join a Phase 3 clinical trial for a drug being investigated specifically for Sjögren's disease, I thought long and hard about it. Then I said yes.
Not because I knew it would work. Not because anyone gave me a guarantee. In fact, you are explicitly asked to sign paperwork acknowledging that there is no guarantee. I said yes because I believe that if those of us who can participate do not, nothing changes. The pipeline stays empty, and the next person diagnosed after me ends up in exactly the position I was in. I enrolled around June of 2024.
What Dazodalibep Is, and How It Works
I want you to understand this drug, not just hear its name. Dazodalibep is a fusion protein, and it targets a cell surface marker called CD40 ligand.
Here is the plain-language version. CD40 ligand is part of a messenger system that lets two kinds of immune cells, B cells and T cells, talk to each other. In Sjögren's disease, that conversation is stuck in overdrive. The two sides will not stop talking. Dazodalibep interrupts that conversation. It is mildly immune suppressing, but not in the broad way some other medications are. In my own experience, I have kept catching the ordinary colds my three school-age kids bring home, but I have not needed antibiotics, and my immune system has handled what it is supposed to handle.
Inside the Trial: Two Years, One IV Bag I Could Not See
The study is double-blind and placebo-controlled. When I enrolled, there were three groups: a consistent monthly dose, a larger dose given every three months, and a placebo, which is essentially sugar water. For that first year, neither I nor the trial coordinator at my site knew which group I was in. That is what double-blind means. I went in every four weeks or so for a 90-minute infusion, and I genuinely did not know what was in the bag, though I had my suspicions.
After the first year, I re-enrolled in what is called an open-label extension. I re-signed the paperwork, and at that point everyone who had been in the placebo group was moved into an active treatment arm. From then on, I knew I was receiving medication, even if I did not know the exact dose.
More recently, Amgen, the company running the trial, adjusted the open-label extension so that everyone moves to the larger dose on the every-three-months schedule. Practically, that meant I could take the summer off from infusions. That is a real relief, because each visit takes most of a day once you count the hour-and-fifteen-minute drive each way, the infusion itself, and the time to place and remove an IV.
What Two Years Actually Changed for Me
This is the part I most want you to hear, and I want to be honest about all of it, including the privilege built into it. I can drive over an hour each way and give up most of a day because I can take the time off, I have childcare, I have a reliable car, and I have flexibility that many people do not. Access to clinical trials is not equal, and that is a problem worth saying out loud.
Over these two years, I have noticed changes I am cautiously, honestly attributing at least in part to being on medication. My dryness has been better at baseline than it used to be. I used to lose my voice to laryngitis whenever a cold settled in, and I cannot remember the last time that happened. My energy and body pain have generally improved from where I started.
I want to be careful here, because I am a physician who knows that placebo effects are real and powerful, and I spent a full year not knowing which group I was in. So I am not going to stand here and tell you this drug is the reason I feel better. We need the data to answer that in numbers bigger than one person. What I can tell you is that my overall trajectory has been positive, and I am grateful for it.
Things are not perfect. When my kids bring home a cold, roughly once a month, the illness still turns up the volume on my dryness and fatigue. Sjögren's disease is still present. This is not a cure, and that word does not belong in this conversation yet. What I hope, and what I find genuinely exciting, is that this medication or others like it might eventually help more patients reach something closer to remission, the way targeted drugs have changed the picture in rheumatoid arthritis.
The Part I Will Not Stop Talking About
Being on the inside of a trial has changed how I advocate. When I get to speak with the researchers running these studies, I push hard on two things.
The first is neurologic symptoms, which most Sjögren's trials are not capturing with enough specificity. The second is seronegative patients, meaning people who have Sjögren's disease clinically but do not show the classic antibodies on bloodwork. They are chronically underrepresented in research. In the ianalumab trial, the goal was for about 10 percent of participants to be seronegative, and it landed closer to 8 percent. That gap is still a gap, and I am not going to stop talking about it until it closes.
What Is Coming Next: The Sjögren's Pipeline
Here is the part I wish more of us heard. There is a great deal happening right now.
Dazodalibep is only one drug in trials. There is also ianalumab from Novartis, which recently reported positive Phase 3 results, nipocalimab from Johnson and Johnson, efgartigimod from argenx, and telitacicept, which has been approved in China. There are more at earlier stages, including CAR T-cell and T-cell engager approaches.
What matters is not just the number of drugs. It is that each one works at a different point in the immune system. That means if one does not work for you, or you cannot tolerate it, there may well be another option that fits better coming right behind it. That is what a real treatment landscape looks like. We are not there yet, but we are moving toward it, and the science is moving faster than it ever has for this disease.
How to Find Out If a Trial Is Right for You
If any of this has made you curious about whether trial participation might be an option for you, here is the one resource to know: clinicaltrials.gov.
Every clinical trial being conducted anywhere in the world is registered and listed there. You can search by condition, location, and zip code, see whether a trial is still recruiting, and read the eligibility criteria. And if there is no site near you, reach out anyway. There is sometimes flexibility for patients willing to travel, and you will not know unless you ask. Your reaching out also plants a flag, because it tells research centers that patients in your area are interested, which matters when they decide where to open new sites.
You Are Not Waiting Passively
Two years ago I sat down in an infusion chair not knowing what was in the bag, because I believe the only way the treatment landscape for Sjögren's disease changes is if those of us who can contribute to the research actually do.
What I love about this community is that, time and again, I see people who are not passively waiting for medicine to catch up with their disease. You are living your life, managing what you have, and still showing up to learn more and do more. That is not a small thing. That is everything. The future for Sjögren's disease is more hopeful than it has ever been, and you are part of the reason why.
Let's Talk
Have you ever looked into a clinical trial, for Sjögren's disease or anything else? What stopped you, or what made you go for it? I would love to hear your story.
When you are ready to take a next step, here are a few free places to start:
Free Lab Conversation Guide: https://immuneconfidentinstitute.com/ic-lab-guide
IC Indicator Quiz (free, 2 minutes): https://immuneconfidentinstitute.com/ic-indicator
The IC Blueprint Checkup, if you want a structured map of your immune terrain to anchor the conversation with your own doctor: https://immuneconfident.com/checkup
The 5th Annual Virtual Sjögren's Summit, July 16 to 18, 2026, registration open now: https://sjogrenssummit.com/register
Note: The IC Blueprint Checkup is an educational assessment and does not establish a Patient-Physician Relationship. Current ICI patients, please message TERRAIN in your portal rather than purchasing.
