NCT06297096 (NINTOC-TU) is a Phase 3 clinical trial of Tocilizumab in Systemic Sclerosis, sponsored by National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland.

What drugs are being tested in NCT06297096?

Interventions in NCT06297096: Tocilizumab, Nintedanib, Standard therapy.

What condition does NCT06297096 study?

NCT06297096 studies Systemic Sclerosis, Interstitial Lung Disease.

Is NCT06297096 still recruiting?

NCT06297096 is currently recruiting now. Last updated 8 April 2026.

Last reviewed 2026-04-08 · How we verify

NCT06297096: NINTOC-TU

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of the Efficacy of Nintedanib+Tocilizumab in Patients With Systemic Sclerosis and Interstitial Lung Disease

Recruiting now Phase 3 Last updated 8 April 2026

What this trial tests

Phase 3 trial testing Tocilizumab in Systemic Sclerosis in 86 participants. Currently enrolling.

Timeline

1 July 2025

Primary endpoint
30 December 2027

30 March 2028

Quick facts

Lead sponsor	National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	86
Start date	1 July 2025
Primary completion	30 December 2027
Estimated completion	30 March 2028
Sites	1 location across Poland

Drugs / interventions tested

Tocilizumab (tocilizumab) — full drug profile →
Nintedanib (NINTEDANIB) — full drug profile →
Standard therapy — full drug profile →

Conditions studied

Systemic Sclerosis — all drugs for Systemic Sclerosis →
Interstitial Lung Disease — all drugs for Interstitial Lung Disease →

Sponsor

National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland

Who can join

Adults 18 to 74, any sex, with Systemic Sclerosis or Interstitial Lung Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study includes adult patients with systemic sclerosis (SSc) with interstitial lung disease (ILD) to evaluate the efficacy and safety of nintedanib plus tocilizumab combination therapy compared to standard therapy (methotrexate, mycophenolate mofetil) for 56 weeks.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Clinical Insights and Therapeutic Strategies for the Treatment of Interstitial Lung Disease in Patients with Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis: Current Trends and Future Directions.
Fijolek J, Sniady A. · · 2025 · cited 1× · PMID 40649005 · DOI 10.3390/jcm14134631

Verify or expand the search:

Other trials of Tocilizumab

Trials testing the same drug.

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NCT07335562 — A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versu · Phase 3 · recruiting
NCT06016517 — Application of the Personalized N-of-1 Trial Design in Patients With Rheumatoid Arthritis · not yet recruiting
NCT06381661 — Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Tra · Phase 2 · not yet recruiting
NCT07509645 — Efficacy and Safety of Interleukin-6 Receptor Inhibitor Combined With Endovascular Treatment in Patients With Acute Post · Phase 3 · recruiting

Other recruiting trials for Systemic Sclerosis

Currently open trials in the same condition.

NCT07335562 — A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versu · Phase 3 · recruiting
NCT06947473 — Umbilical Cord Blood CD19-BCMA CART Cell Therapy for SLE-LN, SSc, andpSS PAH. · Phase 1, PHASE2 · recruiting
NCT07047690 — A Study of Nemolizumab for the Treatment of Adults With Systemic Sclerosis · Phase 2 · recruiting
NCT07246096 — Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Rel · EARLY_PHASE1 · recruiting
NCT07295847 — A Study of AZD0120 in Autoimmune Diseases · Phase 1 · recruiting

Other National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland trials

Trials by the same sponsor.

NCT07242573 — Effect of Physical Exercise and Neuromodulation on Pain, Sleep and Fatigue in Patients With Fibromyalgia · NA · recruiting
NCT06968819 — Virtual Reality and Robotics in Inflammatory Myopathy Rehabilitation · NA · completed
NCT06807177 — Can Blood Biomarkers of Inflammation and BDNF be Used to Assess the Effectiveness of Collagen Mesotherapy in Chronic CMP · enrolling by invitation
NCT06011889 — Study of the Efficacy and Safety of Etanercept Treatment in Patients With SAPHO Syndrome · Phase 2, PHASE3 · recruiting
NCT05967052 — Investigation of Treating Chronic Fatigue Syndrome After COVID With Pharmacotherapy (Pregabalin) or Complex Rehabilitati · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06297096 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
Last refreshed: 8 April 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06297096.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing