Where systemic sclerosis treatment is heading

Systemic sclerosis (scleroderma) is an autoimmune disease that thickens the skin and can scar the lungs, heart, kidneys and gut; about 5,000 people in the US are diagnosed each year, mostly women. Lung scarring is the leading cause of death. Current drugs (mycophenolate, nintedanib, tocilizumab, and stem-cell transplant for severe early disease) slow it but rarely reverse it. CAR T cells that reset the immune system and a wave of new targeted drugs are now in trials.

• 220studies open or running
• 15phase 3 trials
• 1,453papers published this year
• 40NIH-funded projects

1. Now

   Nov 2026

   CAR T cells stop progressionHappened 9 of 9 without progression

   In the CASTLE trial, all 9 people with systemic sclerosis had no lung disease progression after one infusion, off all immune drugs.

   9: of 9 with systemic sclerosis had no disease progression.

   • CASTLE trial (CD19 CAR T cells)

   Protecting the lungsHappened 66% lower risk of major decline

   Tocilizumab cut the risk of a major lung-capacity drop by 66%; nintedanib slowed yearly decline (49.1 vs 74.5 ml).

   66%: lower risk of a 10%+ drop in lung capacity.

   • Tocilizumab meta-analysis
   • SENSCIS analysis (nintedanib)

2. 6 months

   by May 2027

   A first look at anti-TL1A and BAFF-receptor drugsPossible

   Merck's tulisokibart and Novartis' ianalumab phase 2 trials in diffuse skin disease are finishing (2026-2027).

   • Tulisokibart trial
   • Ianalumab trial

3. 12 months

   by Nov 2027

   An interferon blocker in phase 3Possible

   AstraZeneca's DAISY (314 people) tests anifrolumab, approved for lupus; due January 2027.

   • DAISY

   Inhaled antifibroticPossible

   Avalyn's inhaled pirfenidone (398 people) for scleroderma lung disease; due June 2027.

   • AP01 trial

4. 3 years

   by late 2029

   CAR T cells vs standard carePossible 9 of 9 without progression

   Bristol Myers Squibb's Breakfree-SSc compares CD19 CAR T cells with standard treatment; due November 2028.

   9: of 9 with systemic sclerosis had no disease progression.

   • CASTLE trial (CD19 CAR T cells)
   • Breakfree-SSc

   Belimumab for lung diseasePossible

   GSK's BLISSc-ILD (300 people) tests belimumab, approved for lupus; due August 2029.

   • BLISSc-ILD

5. 5 years

   by late 2031

   A new antifibrotic pillPossible

   Boehringer's VERANDA-SSc (448 people) tests nerandomilast, recently approved for lung fibrosis; due February 2030.

   • VERANDA-SSc

The research paths

Borrowed from other conditions

Open to join now

• Systemic sclerosis

  Nerandomilast

  Phase 3 · 248 sites

  Locations and eligibility →

• SSc lung disease

  Belimumab

  Phase 3 · 134 sites

  Locations and eligibility →

• Severe systemic sclerosis

  CABA-201 CAR T cells

  Phase 1/2 · 10 sites

  Locations and eligibility →

• Systemic sclerosis

  AlloNK cord-blood NK cells

  Phase 2 · 52 sites

  Locations and eligibility →

See every recruiting Scleroderma trial →

When the trials finish

Completion dates the trials registered. Results usually follow 3 to 12 months later.

What just happened

Standard treatment today

• Early diffuse skin diseaseMycophenolate or methotrexate; stem-cell transplant for severe, rapidly progressing disease.
• Lung involvement (SSc-ILD)Mycophenolate, plus nintedanib or tocilizumab; rituximab for some.
• Raynaud and finger ulcersCalcium-channel blockers, PDE5 inhibitors, bosentan; botulinum toxin injections.
• Pulmonary hypertensionPAH drugs, often in combination.

See Scleroderma trials recruiting now →