Sjogren’s Syndrome Clinical Trials

It Is Not Just Dry Eyes

The immune system attacks the glands that make tears and saliva, so dryness is the familiar part. However, this is a whole body autoimmune disease, and the rest of it goes badly under recognised. It causes crushing fatigue, joint pain, burning or tingling in the hands and feet, lung scarring and kidney problems. So if you have been told it is just dry eyes and to use drops, that is an incomplete account.

One Blood Test Carries Most of the Weight

Ask for anti-Ro, sometimes written SSA. It is positive in roughly two thirds of people with this, and in the scoring system it is worth three of the four points needed. So a positive result plus one dryness test nearly makes the diagnosis on its own. Notably, that makes it the single most useful test to ask for by name.

A Correction Worth Knowing

Many people are told their anti-La was negative, so they do not have this. That is the wrong way round. In the current criteria, anti-La on its own no longer counts at all, because it turned out not to be specific enough. So a negative anti-La tells you very little. Meanwhile, anti-Ro is the one that matters, and it is the one to insist on.

The Tests That Measure Dryness

The Schirmer test hooks a paper strip over your lower eyelid for five minutes and measures how far it wets. The eye staining score uses dye to grade damage on the surface of the eye, and it tells you more. The saliva test has you drool into a tube for a timed period. Also, note whether a test is stimulated or unstimulated, because studies and criteria use different ones.

The Biopsy, and Who Needs It

A few tiny glands are taken through a small cut inside your lower lip under local anaesthetic. It is the most definitive test, and it is worth three points on its own. So if your anti-Ro is negative, it is the realistic route to a formal diagnosis. However, it carries a small risk of lasting numbness in the lip, and ultrasound of the glands is increasingly used instead.

Why You Can Be Very Ill and Score Low

The activity score used in studies counts organ involvement across twelve areas. It does not score dryness and it does not score fatigue. So somebody whose life has been taken apart by exhaustion can score low and be turned away from studies. In fact, that is why a separate patient scored index exists, covering dryness, fatigue and pain, and it is the number to point at.

Two Studies Here Now Use That Second Number

This matters more than it sounds, because it changes who can get in. One study enrols on a daily symptom diary and a dryness score rather than on organ damage. Meanwhile, another takes women only and makes fatigue its main measure. So the people usually screened out for scoring low now have two doors that the older studies never offered.

Decades With Nothing That Changed the Disease

Every approved treatment is for symptoms. Tablets that squeeze more saliva from remaining glands, anti-inflammatory eye drops, a nasal spray that triggers tears, and drops that slow evaporation. A newer eye drop was approved in May 2025 for dry eye generally. However, none of these touches the disease underneath, and that was the position for decades.

Then October 2025 Broke the Pattern

On 29 October 2025 two late stage trials of the same antibody both hit their target, improving disease activity at 48 weeks against a dummy. They were the first late stage trials in this condition ever to do so. The FDA granted it a fast track designation in January 2026. Meanwhile, as of today it is not approved, and it would be the first targeted treatment for the disease if it is.