Trials that are currently enrolling

Right now, four Phase 3 and four Phase 2 trials are recruiting participants. At the Phase 3 level, two are open: the UPSTREAM SjD trial of telitacicept, which began enrolling adults with active primary Sjögren’s in early 2026, and the dazodalibep long term extension, which is only for people who already finished one of the main dazodalibep trials.

At the Phase 2 level, four trials are actively recruiting: IMVT 1402, tofacitinib, the acoltremon dry eye study, and the AlloNK basket trial. Full eligibility details are in the tables below, along with direct links to each ClinicalTrials.gov page.

Recruitment status can shift quickly. The information here reflects what was listed on ClinicalTrials.gov as of the date of this post, so it is important to double check the current listing before making any decisions about screening or enrollment. If you're new to how clinical trials work or what participation involves, the Patient's Guide to Clinical Trial Participation Part 1 and Part 2 cover what to expect before you decide whether to inquire about any of these studies.

Treatments that are closest to approval

Ianalumab (full drug profile) is one of the first treatments in Sjögren’s to report Phase 3 results. In two large studies (NEPTUNUS-1 and NEPTUNUS-2), people taking the 300 mg monthly dose had greater improvement in disease activity at 48 weeks than those on placebo, based on physician assessments. Novartis shared these early results in August 2025, with more detail presented at a major rheumatology meeting later that year.

The FDA has given ianalumab Breakthrough Therapy designation based on the study’s findings. This can speed how quickly the agency reviews the drug, but it doesn’t guarantee approval. The results have not been published in a peer-reviewed journal, which is when outside experts can closely review the data.

Three other Phase 3 programs are expected to finish their main study periods later this year: a dazodalibep trial in patients with higher systemic disease activity (August), a dazodalibep trial in patients with more symptom‑driven disease (October), and the POETYK SjS‑1 trial of deucravacitinib (November). If these studies are positive, the results could support future applications for FDA approval. Regulatory decisions often take 12 to 18 months after submission, and insurance coverage and access questions come after that.

The Phase 3 landscape

Of the nine Phase 3 trials, three test dazodalibep. Two enroll different patient profiles, one defined mainly by systemic disease activity and the other by symptom burden, and the third is a long‑term extension study. This structure reflects a known challenge in Sjögren’s research: patients with severe symptoms and those with high systemic disease activity often are not the same group, and results in one group do not always translate to the other.

If the phase designations in the table below are unfamiliar, this guide to clinical trial phases explains what each stage means for a drug's development timeline.

Active Phase 2 studies

The current Phase 2 studies fall into two broad groups. Several are testing drugs that work through similar biology as the leading Phase 3 candidates, whether by targeting B cells or the antibodies they produce. IMVT 1402 works much like efgartigimod, which has already moved into Phase 3, and ESG206 targets the same B cell receptor as ianalumab. If the Phase 3 programs succeed, these Phase 2 drugs could represent the next wave of treatments using the same basic approach.

Other trials are exploring different strategies. The AlloNK trial tests whether infusing unmodified donor natural killer cells alongside rituximab can produce a longer-lasting reset of the immune system. This approach comes from cancer treatment and is being tested across Sjögren’s, rheumatoid arthritis, myositis, and systemic sclerosis simultaneously, on the theory that the same immune dysfunction drives all four conditions.

The tofacitinib trial, funded by the NIH rather than industry, is asking a more basic question: whether a JAK inhibitor already approved for other autoimmune conditions is safe enough in Sjogren's to justify studying further.

Completed Phase 2 trials

The efgartigimod Phase 2 results are now available on ClinicalTrials.gov. The study’s data provides the foundation for the Phase 3 Unity trial that is now underway. Looking at both together helps show how the drug is being tested over time.

The ianalumab salivary gland biopsy study has finished but has not posted results yet. When available, that tissue level information should help researchers understand whether the B cell depletion seen in tissue samples from earlier studies explains the clinical improvements reported in the NEPTUNUS trials.

What endpoints mean for patients

One pattern cuts across nearly all these trials. Almost every Phase 3 program uses ESSDAI, a physician‑rated score of systemic disease activity, as its primary endpoint. The ESSPRI symptom score, which captures what patients report about dryness, fatigue, and pain, appears consistently as a secondary endpoint instead.

The one exception is the dazodalibep symptom-focused trial, which uses the patient-reported symptom score as its primary endpoint specifically because it enrolled patients with significant symptoms but lower systemic disease activity. This design choice reflects a documented tension in Sjogren’s research. The patients with high symptom burden and patients with high systemic disease activity frequently don't overlap. The patients most likely to be underrepresented in trials designed around physician-rated activity are often those whose main burden is fatigue, dryness, and pain.

Whether these Phase 3 results will tell us much about what patients actually experience day to day depends on the secondary ESSPRI endpoint data. That information tends to get less attention in press releases than the primary endpoint results, even though it has direct practical implications for patients living with the condition.

To search the full Sjogren’s disease trial listing independently: ClinicalTrials.gov — Sjogren’s syndrome, Phase 2 and later.

Corrections and clarifications always welcome: kelly@theconnectivethread.com.

The Connective Thread is written by a patient, not a clinician. Nothing here is medical advice.