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Condition (MeSH)

Scleroderma, Systemic

ClinicalTrials.gov lists 751 trials for Scleroderma, Systemic or a narrower condition beneath it. Actelion has the most among industry and government lead sponsors, with 11.

MeSH D012595 Skin and Connective Tissue Diseases C17 Listed by Orphanet as a rare disease
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Phase 1 Phase 1 107 Phase 1/2 Phase 1/2 47 Phase 2 Phase 2 125 Phase 2/3 Phase 2/3 22 Phase 3 Phase 3 50 Phase 4 Phase 4 24 Not applicable Not applicable 178 Observational Observational 196 Phase 1 Phase 1 107 Phase 1/2 Phase 1/2 47 Phase 2 Phase 2 125 Phase 2/3 Phase 2/3 22 Phase 3 Phase 3 50 Phase 4 Phase 4 24 Not applicable Not applicable 178 Observational Observational 196

Trials per phase

1 more section with rows

591 of the 751 trials are tagged with Scleroderma, Systemic 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 Scleroderma, Systemic trials start? (33)

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. 2 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

Top of scale: 76

1991: 1 trials (Phase 2 1) 1992: 1 trials (Observational 1) 1995: 2 trials (Observational 1, Phase 3 1) 1997: 2 trials (Not applicable 1, Phase 2 1) 1998: 2 trials (Observational 1, Phase 3 1) 1999: 3 trials (Observational 1, Phase 3 1, Phase 1 1) 2000: 5 trials (Observational 1, Phase 2 2, Phase 1 2) 2001: 7 trials (Observational 1, Not applicable 1, Phase 4 1, Phase 3 2, Phase 2 2) 2002: 4 trials (Observational 1, Phase 1/2 2, Phase 1 1) 2003: 4 trials (Phase 3 2, Phase 2/3 1, Phase 1 1) 2004: 8 trials (Observational 1, Not applicable 1, Phase 4 1, Phase 3 1, Phase 2/3 3, Phase 2 1) 2005: 8 trials (Observational 2, Not applicable 1, Phase 3 1, Phase 2/3 1, Phase 2 1, Phase 1/2 1, Phase 1 1) 2006: 14 trials (Observational 4, Not applicable 1, Phase 4 1, Phase 3 2, Phase 2 4, Phase 1/2 1, Phase 1 1) 2007: 20 trials (Observational 6, Not applicable 1, Phase 3 3, Phase 2/3 2, Phase 2 4, Phase 1/2 2, Phase 1 2) 2008: 13 trials (Observational 3, Not applicable 2, Phase 3 1, Phase 2 4, Phase 1/2 2, Phase 1 1) 2009: 13 trials (Observational 2, Not applicable 1, Phase 4 1, Phase 3 2, Phase 2 4, Phase 1/2 2, Phase 1 1) 2010: 15 trials (Observational 4, Not applicable 3, Phase 4 2, Phase 3 3, Phase 2 2, Phase 1 1) 2011: 21 trials (Observational 4, Not applicable 3, Phase 4 1, Phase 3 4, Phase 2/3 1, Phase 2 6, Phase 1/2 1, Phase 1 1) 2012: 18 trials (Observational 7, Not applicable 4, Phase 4 1, Phase 3 2, Phase 2 3, Phase 1/2 1) 2013: 24 trials (Observational 13, Not applicable 3, Phase 3 2, Phase 2/3 2, Phase 2 3, Phase 1 1) 2014: 25 trials (Observational 6, Not applicable 7, Phase 3 1, Phase 2/3 2, Phase 2 6, Phase 1/2 2, Phase 1 1) 2015: 27 trials (Observational 6, Not applicable 6, Phase 4 2, Phase 3 3, Phase 2 7, Phase 1/2 2, Phase 1 1) 2016: 29 trials (Observational 8, Not applicable 7, Phase 4 2, Phase 3 1, Phase 2 7, Phase 1 4) 2017: 29 trials (Observational 6, Not applicable 9, Phase 4 1, Phase 3 1, Phase 2/3 2, Phase 2 5, Phase 1/2 3, Phase 1 2) 2018: 36 trials (Observational 12, Not applicable 14, Phase 4 1, Phase 3 1, Phase 2/3 2, Phase 2 2, Phase 1/2 1, Phase 1 3) 2019: 37 trials (Observational 9, Not applicable 11, Phase 4 1, Phase 3 2, Phase 2 10, Phase 1/2 1, Phase 1 3) 2020: 28 trials (Observational 7, Not applicable 11, Phase 4 1, Phase 2/3 1, Phase 2 6, Phase 1 2) 2021: 53 trials (Observational 16, Not applicable 22, Phase 2/3 1, Phase 2 10, Phase 1/2 2, Phase 1 2) 2022: 46 trials (Observational 15, Not applicable 15, Phase 4 2, Phase 3 3, Phase 2/3 2, Phase 2 5, Phase 1/2 1, Phase 1 3) 2023: 39 trials (Observational 14, Not applicable 9, Phase 4 1, Phase 3 3, Phase 2/3 1, Phase 2 2, Phase 1/2 3, Phase 1 6) 2024: 69 trials (Observational 18, Not applicable 16, Phase 4 3, Phase 3 2, Phase 2/3 1, Phase 2 7, Phase 1/2 8, Phase 1 14) 2025: 76 trials (Observational 16, Not applicable 16, Phase 4 1, Phase 3 2, Phase 2 7, Phase 1/2 4, Phase 1 30)

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) 65
2025 76
2024 69
2023 39
2022 46
2021 53
2020 28
2019 37
2018 36
2017 29

Showing 10 of 33 earlier years.

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Forecast of the full-year count, planned starts included, not rows of this table: about 78 trials starting in 2026 and about 74 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 15 percent and ran about 1 percent high against the count later registered; forecasts made before the year began were off by about 26 percent and ran about 20 percent low against the count later registered. The part-way figures are from forecasts that used a multiple fitted only on earlier years. 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 105 trials still running at the 2026-10-09 snapshot; registered median of 24 months across 372 trials with a primary completion typed Actual. Source: ClinicalTrials.gov / AACT (CTTI), public domain.

What phase are Scleroderma, Systemic trials in? (9)

Shown in this order: phase order.

Show the trials by phase as a table
Trials by phase
Phase Trials
Phase 1 107
Phase 1/2 47
Phase 2 125
Phase 2/3 22
Phase 3 50
Phase 4 24
Not applicable 178
Observational 196
Expanded access 2

How many Scleroderma, Systemic trials are recruiting? (11)

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 58
Recruiting 149
Enrolling by invitation 13
Active, not recruiting 26
Available 1

Showing 5 of 11 statuses.

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

Which lead sponsors run the most Scleroderma, Systemic trials? (2)

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
Actelion 11
MediQuest Therapeutics 6

Which drugs are being tested for Scleroderma, Systemic? (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
Cytoxan 30
RITUXIMAB 12
BOSENTAN 12
Imatinib 8
SILDENAFIL 5

Showing 5 of 6 drugs.

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Interventions as named in the registry (9)

Shown in this order: most trials first.

Interventions as named in the registry
Drug Trials
SQ Fludarabine 19
Mofetil Mycophenolate 14
BLOOD SAMPLE 6
BLOOD SAMPLES 5
Pirfenidoneone 5

Showing 5 of 9 interventions.

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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 Scleroderma, Systemic 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
Pneumonia 43 15
Interstitial lung disease 21 5
Dyspnoea 18 6
Skin ulcer 18 7
SKIN ULCER 17 4

Showing 5 of 10 adverse events.

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Which publications cover Scleroderma, Systemic? (691)

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

Publications
Publication Journal Year Major topic
Systemic sclerosis: pathogenic mechanisms and their implications for treatment. Seminars in immunopathology 2025 Yes
A composite endpoint for systemic sclerosis-associated interstitial lung disease: association with mortality in two clinical trial cohorts. Respiratory research 2025 Yes
Well-Being Therapy in systemic sclerosis outpatients: a randomized controlled trial. Rheumatology (Oxford, England) 2025 Yes
Efficacy of methylprednisolone in very early systemic sclerosis: results of the 'Hit Hard and Early' randomized controlled trial. Rheumatology (Oxford, England) 2025 Yes
Do functionality, strength, vascularization, inflammatory and biopsychosocial status improve by biopsychosocial model-based exercise in SSc? Rheumatology (Oxford, England) 2025 Yes

Showing 5 of 691 publications.

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Prevalence (51)

Shown in this order: jurisdiction, then disease name. Orphanet observation for the mapped ORPHA concept; the mapping relation column says whether that concept is exactly this condition or broader or narrower.

Prevalence
Orphanet disease Type Class Geography Jurisdiction Mapping relation
Systemic sclerosis Point prevalence 1-9 / 100 000 United Kingdom GB Exact
Systemic sclerosis Point prevalence 1-9 / 100 000 United Kingdom GB Unspecified
Systemic sclerosis Point prevalence 1-9 / 100 000 United Kingdom GB Exact
Systemic sclerosis Point prevalence 1-5 / 10 000 United States US Exact
Systemic sclerosis Point prevalence 1-5 / 10 000 United States US Exact

Showing 5 of 51 prevalence observations.

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Rare-disease identity (2)

Shown in this order: exact, broader, narrower, other.

Rare-disease identity
Orphanet disease ORPHA code Relation Source
Systemic sclerosis 90291 Exact Orphadata Science knowledge files, Product 1
Systemic sclerosis 90291 Exact Orphanet Rare Disease Ontology (ORDO)

Sub-conditions in MeSH (2)

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

Not on this page

Not measured: delivery record.

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