Systemic Sclerosis Clinical Landscape Report 2026: Trials, Readouts and White Space
Turn fragmented clinical intelligence into a decision-ready landscape. This report was assembled with PatSnap MCP Servers for Clinical Trials, Drug & Asset, and Company & Deal Intelligence. Explore the PatSnap MCP Marketplace to reproduce the workflow in your own AI research stack.
Data snapshot: 16 July 2026. This report is a strategic research view, not medical advice. Trial status and timing can change; confirm records before making development or investment decisions.
Executive view
Systemic Sclerosis remains an active clinical development field. Clinical competition is shifting from broad immunosuppression toward pathway-selective control, durable remission and treatment strategies that reduce steroid exposure without trading away safety. The PatSnap evidence set used here contains 395 matched trial records and 210 indexed result records before the decision-focused sample below was selected.
How PatSnap MCP built this report
The workflow used Clinical Trials MCP search to define the landscape, then clinical_trial_fetch to retrieve trial design, phase, status, sponsor, geography, endpoints and timing. It separately called clinical_trial_result_fetch for indexed readouts. Drug & Asset drug_fetch supplied target and global development status, while Company & Deal Intelligence organization_fetch supplied sponsor context. This keeps trial-, asset- and company-level claims distinct and traceable.
Trial landscape table
| Trial | Asset / intervention | Phase / status | Sponsor | Geography | Primary endpoint | Expected readout |
|---|---|---|---|---|---|---|
| NCT07697274 | Hyaluronidase Recombinant Human | Early Phase 1; Not yet recruiting | The Medical University of South Carolina | United States | Feasibility Assessment (28 weeks); Evaluate Safety (32 weeks) | 2027-09-01 |
| NCT07676266 | C-CAR168 | Phase 1; Not yet recruiting | The Affiliated Hospital of Qingdao University | China | Incidence and severity of Adverse Events [Safety and Tolerability] (Throughout the first 3 months follow up period completion); The subsequent recommended dose of C-CAR168 in patients with autoimmune diseases refractory to standard therapy (Throughout the first 24 months follow up period completion) | 2027-11-01 |
| NCT07674147 | RD-0605 | Early Phase 1; Not yet recruiting | The Children's Hospital of Zhejiang University School of Medicine | China | Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs) (From signing of informed consent through 90 days post-infusion (for related…) | 2029-07-01 |
| JPRN-jRCTs031260239 | [18F]FAPI-74 + 18F-FAPI | Phase 2; 募集中 | Sponsor not listed | Japan | 【FALCON cross sectional study】 %DLCO（Hb補正） 【FALCON prospective cohort study】 観察期間におけるPPFの発生; [FALCON cross sectional study] %DLCO (hemoglobin-corrected) [FALCON prospective cohort study] Occurrence of PPF during the observation period | 2029-07-31 |
The table is designed for competitive decisions: endpoint selection, geographic reach and readout timing appear beside phase and sponsor. Phase alone does not reveal evidence maturity; a small study may answer a near-term biomarker question while a large pivotal program can leave a multi-year readout gap.
What indexed results say
- RAYNAUD’S SEVERITY, DIGITAL ULCERS, SKIN SCLEROSIS EXTENT AND DISEASE ACTIVITY IN SYSTEMIC SCLEROSIS PATIENTS TREATED WITH BOSENTAN: THE 18-MONTH CURE PROSPECTIVE OPEN STUDY (Not Applicable): the indexed record reports mRSS = -0.6 Point.
- B-CELL–DIRECTED CAR-BASED CELLULAR THERAPIES FOR AUTOIMMUNE RHEUMATIC DISEASES: A SYSTEMATIC REVIEW (Not Applicable): the indexed record reports CRS(grade 1) = 44.0 Pts.
- MACITENTAN FOR SYSTEMIC SCLEROSIS-RELATED DIGITAL VASCULOPATHY: EFFICACY AND SAFETY FROM ON-LABEL AND OFF-LABEL REAL-LIFE COHORTS (Not Applicable): the indexed record reports AE(discontinuation) = Macitentan was discontinued in three patients due to headache, nausea, and flushing - symptoms previously experienced with bosentan - while no cases of elevated transaminases were observed.; AE(discontinuation) = Macitentan was discontinued in three patients due to headache, nausea, and flushing - symptoms previously experienced with bosentan - while no cases of elevated transaminases were observed..
Cross-trial comparisons require caution. Population, prior therapy, baseline risk, endpoint definition, follow-up and analysis set can all change the apparent signal. The strategic value lies in identifying what each readout resolves—and which uncertainty remains.
Build a living clinical map: connect to PatSnap MCP Servers and combine trial design, result, asset and organization records without manually reconciling separate databases.
Asset and sponsor context
PatSnap Drug & Asset records add mechanism and global development status for the sampled programs, including Hyaluronidase Recombinant Human (Approved; Hyaluronic acid), C-CAR168 (Phase 1/2; BCMA x CD20), RD-0605 (Early Phase 1; BCMA x CD19), [18F]FAPI-74 (Phase 3; FAP), 18F-FAPI (Phase 2/3). Company & Deal Intelligence records identify sponsor context for The Medical University of South Carolina, The Affiliated Hospital of Qingdao University, The Children's Hospital of Zhejiang University School of Medicine. Together, those layers show whether a study sits inside a scaled portfolio, an emerging specialist strategy or an academic development path.
Where the white space is
- Standard definitions for steroid-free remission and durable disease control.
- Head-to-head trials against current targeted standards, not placebo alone.
- Biomarker strategies that distinguish mechanistic responders before prolonged treatment.
- Long-term infection, malignancy and immune-reconstitution follow-up.
Strategic implications
For sponsors, differentiation is more credible when the evidence package resolves a known decision gap: an active comparator, a better-defined responder population, a safer or easier delivery model, a clinically meaningful outcome, or a defensible sequencing strategy. Business-development teams can use the same landscape to separate crowded mechanisms from differentiated evidence architectures. Investors should track endpoint maturity and operational feasibility alongside nominal phase.
What to monitor next
Track status changes, protocol amendments, primary-completion dates, newly indexed results, ownership changes and multinational expansion. Re-run the MCP queries on a schedule and compare deltas. Pay particular attention when a program moves from a surrogate endpoint to a clinical outcome or when a specialist sponsor adds a scaled development partner.
Bottom line
Systemic Sclerosis has meaningful clinical activity and equally meaningful evidence gaps. A useful landscape connects trial design, results, mechanism and sponsor rather than listing studies in isolation.
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