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Condition (MeSH)

Autoimmune Diseases

ClinicalTrials.gov lists 15,217 trials for Autoimmune Diseases or a narrower condition beneath it. Hoffmann-La Roche has the most among industry and government lead sponsors, with 279.

MeSH D001327 Immune System Diseases C20
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Phase 1 Phase 1 1,475 Phase 1/2 Phase 1/2 486 Phase 2 Phase 2 1,936 Phase 2/3 Phase 2/3 256 Phase 3 Phase 3 1,612 Phase 4 Phase 4 1,037 Not applicable Not applicable 4,128 Observational Observational 4,244 Phase 1 Phase 1 1,475 Phase 1/2 Phase 1/2 486 Phase 2 Phase 2 1,936 Phase 2/3 Phase 2/3 256 Phase 3 Phase 3 1,612 Phase 4 Phase 4 1,037 Not applicable Not applicable 4,128 Observational Observational 4,244

Trials per phase

1 more section with rows

783 of the 15,217 trials are tagged with Autoimmune Diseases itself; the rest are tagged with a narrower condition beneath it.

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The PDF carries up to 50 rows of each section, where the page shows the first few, with the sources listed. Enter a work email and confirm it from the message we send, and the report follows by email.

When did Autoimmune Diseases trials start? (37)

Shown in this order: most recent first, 1990 onwards. 2026 is partial: trials registered with a 2026 start date so far, not a full year. 30 trials are registered to start in 2027 or later, and not listed here.

Trials over time, by phase

  • Phase 1
  • Phase 1/2
  • Phase 2
  • Phase 2/3
  • Phase 3
  • Phase 4
  • Not applicable
  • Observational
  • Other (Expanded access)

Top of scale: 1,028

1990: 4 trials (Observational 1, Not applicable 1, Phase 2 2) 1991: 6 trials (Observational 3, Not applicable 1, Phase 3 1, Phase 2 1) 1992: 5 trials (Observational 4, Phase 3 1) 1993: 7 trials (Observational 4, Not applicable 2, Phase 3 1) 1994: 14 trials (Observational 7, Not applicable 3, Phase 4 1, Phase 3 1, Phase 2/3 1, Phase 2 1) 1995: 18 trials (Observational 4, Not applicable 3, Phase 4 1, Phase 3 4, Phase 2/3 1, Phase 2 3, Phase 1 2) 1996: 24 trials (Observational 10, Not applicable 1, Phase 4 3, Phase 3 5, Phase 2 4, Phase 1 1) 1997: 33 trials (Other 1, Observational 3, Not applicable 2, Phase 4 3, Phase 3 9, Phase 2/3 2, Phase 2 9, Phase 1 4) 1998: 28 trials (Observational 10, Phase 4 4, Phase 3 5, Phase 2/3 1, Phase 2 2, Phase 1/2 2, Phase 1 4) 1999: 39 trials (Observational 11, Not applicable 1, Phase 4 2, Phase 3 8, Phase 2/3 2, Phase 2 13, Phase 1/2 1, Phase 1 1) 2000: 57 trials (Observational 9, Not applicable 9, Phase 4 2, Phase 3 12, Phase 2/3 1, Phase 2 19, Phase 1/2 3, Phase 1 2) 2001: 93 trials (Observational 16, Not applicable 14, Phase 4 8, Phase 3 20, Phase 2/3 4, Phase 2 15, Phase 1/2 5, Phase 1 11) 2002: 147 trials (Observational 24, Not applicable 6, Phase 4 18, Phase 3 42, Phase 2/3 4, Phase 2 36, Phase 1/2 5, Phase 1 12) 2003: 189 trials (Observational 28, Not applicable 22, Phase 4 34, Phase 3 33, Phase 2/3 6, Phase 2 38, Phase 1/2 11, Phase 1 17) 2004: 211 trials (Observational 48, Not applicable 24, Phase 4 34, Phase 3 35, Phase 2/3 13, Phase 2 36, Phase 1/2 7, Phase 1 14) 2005: 272 trials (Other 1, Observational 58, Not applicable 32, Phase 4 24, Phase 3 60, Phase 2/3 7, Phase 2 58, Phase 1/2 13, Phase 1 19) 2006: 324 trials (Observational 72, Not applicable 45, Phase 4 34, Phase 3 67, Phase 2/3 6, Phase 2 64, Phase 1/2 17, Phase 1 19) 2007: 375 trials (Observational 87, Not applicable 46, Phase 4 45, Phase 3 72, Phase 2/3 12, Phase 2 62, Phase 1/2 16, Phase 1 35) 2008: 384 trials (Other 1, Observational 92, Not applicable 52, Phase 4 31, Phase 3 61, Phase 2/3 9, Phase 2 81, Phase 1/2 16, Phase 1 41) 2009: 447 trials (Other 2, Observational 112, Not applicable 78, Phase 4 50, Phase 3 65, Phase 2/3 9, Phase 2 64, Phase 1/2 18, Phase 1 49) 2010: 509 trials (Observational 127, Not applicable 84, Phase 4 52, Phase 3 67, Phase 2/3 6, Phase 2 85, Phase 1/2 18, Phase 1 70) 2011: 531 trials (Observational 148, Not applicable 104, Phase 4 55, Phase 3 67, Phase 2/3 11, Phase 2 68, Phase 1/2 17, Phase 1 61) 2012: 614 trials (Observational 190, Not applicable 116, Phase 4 47, Phase 3 80, Phase 2/3 10, Phase 2 90, Phase 1/2 20, Phase 1 61) 2013: 589 trials (Observational 148, Not applicable 155, Phase 4 59, Phase 3 69, Phase 2/3 8, Phase 2 76, Phase 1/2 21, Phase 1 53) 2014: 620 trials (Observational 154, Not applicable 192, Phase 4 43, Phase 3 79, Phase 2/3 7, Phase 2 68, Phase 1/2 20, Phase 1 57) 2015: 597 trials (Observational 154, Not applicable 151, Phase 4 49, Phase 3 64, Phase 2/3 7, Phase 2 84, Phase 1/2 20, Phase 1 68) 2016: 623 trials (Observational 164, Not applicable 194, Phase 4 50, Phase 3 54, Phase 2/3 7, Phase 2 85, Phase 1/2 11, Phase 1 58) 2017: 613 trials (Observational 177, Not applicable 198, Phase 4 39, Phase 3 47, Phase 2/3 10, Phase 2 62, Phase 1/2 19, Phase 1 61) 2018: 691 trials (Observational 199, Not applicable 259, Phase 4 29, Phase 3 66, Phase 2/3 7, Phase 2 62, Phase 1/2 15, Phase 1 54) 2019: 761 trials (Observational 223, Not applicable 273, Phase 4 40, Phase 3 57, Phase 2/3 11, Phase 2 86, Phase 1/2 20, Phase 1 51) 2020: 731 trials (Observational 267, Not applicable 238, Phase 4 48, Phase 3 43, Phase 2/3 7, Phase 2 71, Phase 1/2 10, Phase 1 47) 2021: 882 trials (Observational 316, Not applicable 272, Phase 4 45, Phase 3 68, Phase 2/3 16, Phase 2 84, Phase 1/2 15, Phase 1 66) 2022: 852 trials (Observational 274, Not applicable 287, Phase 4 41, Phase 3 77, Phase 2/3 19, Phase 2 81, Phase 1/2 19, Phase 1 54) 2023: 899 trials (Observational 277, Not applicable 331, Phase 4 28, Phase 3 62, Phase 2/3 13, Phase 2 104, Phase 1/2 21, Phase 1 63) 2024: 939 trials (Observational 287, Not applicable 322, Phase 4 45, Phase 3 56, Phase 2/3 14, Phase 2 69, Phase 1/2 35, Phase 1 111) 2025: 1,028 trials (Observational 279, Not applicable 322, Phase 4 33, Phase 3 68, Phase 2/3 9, Phase 2 106, Phase 1/2 42, Phase 1 169)

Trials registered with a start date in each year, 1990 onward, stacked by phase (complete years only; the current partial year is in the table's notes). The table below lists the same counts, most recent years first.

Trials started per year
Year Trials started
2026 (partial year) 928
2025 1,028
2024 939
2023 899
2022 852
2021 882
2020 731
2019 761
2018 691
2017 613

Forecast of the full-year count, planned starts included, not rows of this table: about 1,200 trials starting in 2026 and about 1,000 in 2027, the average of the 24 months through September, counted as registered and carried forward, with about 0.7 times the starts already registered for the rest of 2026 added. The rows of this table count trials registered so far with a start date in the year, planned starts included; the forecast looks ahead to the count for the whole year, so it is not the same measure. In backtests on conditions of this size, forecasts made part-way through the year were typically off by about 10 percent and ran about 4 percent high against the count later registered; forecasts made before the year began were off by about 25 percent and ran about 15 percent low against the count later registered, and had about 7 percent more error than repeating last year's count. The part-way figures are from forecasts that used a multiple fitted only on earlier years. A stricter check that trains only on older years did not support adding planned starts for conditions of this size: it ran about 6 percent high against the count later registered. These figures rest on a few years of history (target years from 2018 to 2025, varying by figure), place each condition as it is mapped today rather than as it was then, and score against a count for the newest year that was still being revised. Only condition series were scored.

Prediction, not a registry value: median of 36 months from start to primary completion across 1,450 trials still running at the 2026-10-09 snapshot; registered median of 22 months across 9,249 trials with a primary completion typed Actual. Source: ClinicalTrials.gov / AACT (CTTI), public domain.

What phase are Autoimmune Diseases trials in? (9)

Shown in this order: phase order.

Show the trials by phase as a table
Trials by phase
Phase Trials
Phase 1 1,475
Phase 1/2 486
Phase 2 1,936
Phase 2/3 256
Phase 3 1,612
Phase 4 1,037
Not applicable 4,128
Observational 4,244
Expanded access 43

How many Autoimmune Diseases trials are recruiting? (13)

Shown in this order: the order a trial moves through, from not yet recruiting to unknown.

Trials by recruitment status
Status Trials
Not yet recruiting 760
Recruiting 1,876
Enrolling by invitation 132
Active, not recruiting 592
Available 7

Status as registered on ClinicalTrials.gov. Each trial is counted once.

Which lead sponsors run the most Autoimmune Diseases trials? (12)

Shown in this order: most trials first. Lead sponsors the registry classes as industry, NIH, US federal, other government or network. A hospital or university the registry files as government can appear here. Sponsors it classes as academic or other are shown on the full page, because that class cannot separate an institution from a named investigator.

Lead sponsors
Sponsor Trials
Hoffmann-La Roche 279
Novo Nordisk A/S 241
Novartis Pharmaceuticals 216
Biogen 191
Pfizer 150

Which drugs are being tested for Autoimmune Diseases? (6)

Shown in this order: most trials first. One row per drug, matched to a single molecule under all its names, ranked by number of trials.

Drugs tested
Drug Trials
RITUXIMAB 238
Insulin Aspart 135
METHYLPREDNISOLONE 117
Prednisone 115
Cytoxan 108

Interventions as named in the registry (9)

Shown in this order: most trials first.

Interventions as named in the registry
Drug Trials
HD- Methotrexate (MTX) 298
tocilizumab SC 150
Glargine Insulin 145
Adalimumab-US 139
1=Etanercept 131

These are the names sponsors entered on ClinicalTrials.gov that we have not matched to a single molecule. Some are drugs under a brand or code name; others are procedures, doses or arm labels.

Which serious adverse events do Autoimmune Diseases trials report? (10)

Shown in this order: most subjects affected first. Subjects affected summed across trials, a cross-trial signal, not a rate.

Serious adverse events in this condition's trials
Adverse event Subjects affected Trials
Surgical and medical procedures 11,837 5
Neoplasms benign, malignant and unspecified (incl cysts and polyps) 5,174 2
Pneumonia 4,441 597
Investigations 3,745 3
Infections and infestations 3,350 4

Which publications cover Autoimmune Diseases? (1,189)

Shown in this order: major-topic papers first, then newest, then most linked to trials.

Sub-conditions in MeSH (29)

MeSH descendants one level down with at least one trial, most trials first.

Not on this page

Not measured: delivery record.

Checked, with nothing recorded for this condition: prevalence and rare-disease identity.

Browse all condition evidence pages