DrugEvidence

Diseases / Autoimmune Diseases

Autoimmune Diseases

Disease

Autoimmune diseases are conditions in which the immune system mistakenly attacks the body's own tissues and organs. They comprise many disorders affecting multiple organ systems.

Trials
776
Recruiting
173
Completed
340
With results
108

Last revised

Pipeline

Phase by status

PhaseRecruitingNot yetBy invitationActiveCompletedTerminatedWithdrawnSuspendedUnknownApproved for marketingTotal
Early Phase 1 201151126 46
Phase 1 23613649517 119
Phase 1/2 1282313843 53
Phase 2 17411571729 117
Phase 2/3 43 7
Phase 3 91163362 58
Phase 4 41111315 26
Not applicable 36935431115 122
Unknown 48126698106411 228

Trials started per year

2021
11
2022
50
2023
48
2024
71
2025
66
2026
63
2027
4

Conditions studied, by phase

ConditionEarly Phase 1Phase 1Phase 1/2Phase 2Phase 2/3Phase 3Phase 4Not applicableUnknownTotal
Autoimmune Diseases 461195311775826122228 776
Lupus Erythematosus, Systemic 132812151951519 126
Immune System Diseases 1158261921125 107
Arthritis, Rheumatoid 2126121621227 80
Multiple Sclerosis 1129821615 63
Diabetes Mellitus, Type 1 7614221515 61
Scleroderma, Systemic 8155442168 53
Diabetes Mellitus 65624123 38
Connective Tissue Diseases 17710236 36
Sjogren's Syndrome 54293111 35

Most active sponsors

#SponsorTrialsPhase 3
1National Institute of Allergy and Infectious Diseases (NIAID)221
2GlaxoSmithKline181
3Assistance Publique - Hôpitaux de Paris170
4National Heart, Lung, and Blood Institute (NHLBI)130
5Novartis Pharmaceuticals114
6Peking Union Medical College Hospital110
7National Cancer Institute (NCI)100
8National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)80
9Cabaletta Bio72
10Human Genome Sciences Inc., a GSK Company75

Most studied interventions

#InterventionTrials
1Cyclophosphamide26
2Blood Specimen Collection21
3fludarabine21
4belimumab16
5Rituximab14
6Prednisone12
7Mycophenolic Acid11
8Methotrexate9
9Standard of Care9
10Cyclosporine8

Evidence

Results reported
31.8%108 of 340 completed
Published
17.6%60 of 340 completed
Primary endpoint met
31.8%21 of 66 analyses
Median months to report
12

Documents disclosed

Protocol available
67
Statistical analysis plan
63
PubMed citations
272

Trial profile

Median enrollment
60
Median duration
35.8months
Countries
83
Study sites
6788

Who is enrolled

Adults
765
Children
193
Older adults
621
Healthy volunteers
162

Median enrollment by phase

Early Phase 1
20
Phase 1
24
Phase 1/2
24
Phase 2
54
Phase 2/3
66
Phase 3
231
Phase 4
104
Not applicable
48
Unknown
275

Where trials run

United States
335
China
118
France
89
United Kingdom
70
Germany
68
Spain
62
Canada
55
Italy
48
Australia
46
Poland
44

Busiest cities

#CityCountryTrials
1HoustonUnited States67
2BethesdaUnited States66
3New YorkUnited States65
4BostonUnited States56
5Los AngelesUnited States52
6LondonUnited Kingdom46
7BeijingChina45
8ChicagoUnited States44
9PhiladelphiaUnited States40
10BarcelonaSpain39

Terminations

Terminated
55
Withdrawn
21
Suspended
4
Stopped for recruitment
1.5%12 of 776 trials

Stated reasons

Other / unclear
32
Business decision
16
Recruitment
12
Lack of efficacy
8
COVID-19
5
Funding
5
Regulatory
2

Reasons are grouped from the sponsor's own wording with a rule-based classifier; the original text is shown below.

Recently stopped

TrialStatusStated reasonStopped
NCT07604792 Suspended Suspended Enrollment is suspended to address regulatory requirements. Follow-up of currently enrolled participants continues as planned. 2041-11-30
NCT05627089 Withdrawn Withdrawn Decided not to move forward 2035-01-01
NCT07006805 Withdrawn Withdrawn The study was withdrawn prior to site activation and before enrollment of any participants due to sponsor decision to reprioritize the development portfolio. 2029-10-31
NCT06752876 Withdrawn Withdrawn Sponsor Strategic Pipeline Prioritization with Focus on CB-010 and CB-011 Oncology Programs 2029-04-30
NCT06677710 Suspended Suspended Business Reasons 2028-12-31
NCT03461419 Suspended Suspended Withdrawn \[COVID restrictions prevent patient enrollment or treatment. Clinical Trial facility is being closed due to viral limitations and loss of staff to perform\] 2028-12-15
NCT05480657 Withdrawn Withdrawn Study withdrawn 2028-08-31
NCT06549296 Suspended Suspended R\&D strategy adjustment 2027-08-01
NCT06291415 Withdrawn Withdrawn Sponsor decision 2026-11-30
NCT05678374 Terminated Terminated We had initially planned to include 60 participants per group. However, due to substantial difficulties with participant recruitment, we decided to close the study after enrolling 39, 15, and 40 participants in the respective groups. 2026-08-18

Trial records