NCT04598815 (SIRGO) is a Phase 2 clinical trial of Sirolimus in Graves Ophthalmopathy, sponsored by University of Pisa.

Who is sponsoring NCT04598815?

NCT04598815 is sponsored by University of Pisa.

What drugs are being tested in NCT04598815?

Interventions in NCT04598815: Sirolimus.

What condition does NCT04598815 study?

NCT04598815 studies Graves Ophthalmopathy.

Is NCT04598815 still recruiting?

NCT04598815 is currently status unknown. Last updated 15 March 2023.

Last reviewed 2023-03-15 · How we verify

NCT04598815: SIRGO

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

Sirolimus for Graves' Orbitopathy (GO)

Status unknown Phase 2 Last updated 15 March 2023

What this trial tests

Phase 2 trial testing Sirolimus in Graves Ophthalmopathy in 54 participants. Status unknown.

Timeline

1 June 2023

Primary endpoint
31 May 2024

31 May 2025

Quick facts

Lead sponsor	University of Pisa
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	54
Start date	1 June 2023
Primary completion	31 May 2024
Estimated completion	31 May 2025
Sites	1 location across Italy

Drugs / interventions tested

Sirolimus (sirolimus) — full drug profile →

Conditions studied

Graves Ophthalmopathy — all drugs for Graves Ophthalmopathy →

Sponsor

University of Pisa

Who can join

Adults 18 to 75, any sex, with Graves Ophthalmopathy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Graves' Orbitopathy (GO) is a disabling and disfiguring condition associated with Graves' Disease, due to autoimmunity against antigens expressed by the thyroid and orbital tissues, and resulting in orbital fibroblast proliferation and release of glycosaminoglycans. The current treatments available, especially glucocorticoids, are not effective in all patients. Two cases of patients with GO treated with Sirolimus have been reported with an excellent response to the drug. The rationale for the use of Sirolimus lies in its mechanisms of action. Sirolimus is able to inhibit T-cell activation as well as fibroblast proliferation. In addition, acts indirectly on the Insulin-Like Growth Factor-1 (IGF-1) pathway, and recent clinical trials have shown that a monoclonal antibody against the IGF-1 receptor (Teprotumumab) is effective in patients with GO. Thus, Sirolimus could be used in GO as monotherapy in patients with GO. The aim of the present drug vs standard treatment, open-label, randomized clinical trial is to evaluate the efficacy of Sirolimus in patients with moderately severe, active GO. 54 patients (27 per group) will be randomized into two groups, A and B. Patients in group A will receive Sirolimus for 12 weeks. Patients in group B will receive methylprendnisolone for 12 weeks. The primary objective of the study is the response of GO at 24 weeks based on a composite evaluation. The secondary Objectives will be: 1) the response of of GO at 12, 36 and 48 weeks; 2) Relapse of GO at 36 and 48 weeks (worsening compared with the 24-week evaluation); 3) The reduction of proptosis at 12, 24, 36 and 48 weeks (proportion of patients with a reduction of proptosis of at least 2 mm); 4) Reduction of the GO clinical activity score (CAS) at 12, 24, 36 and 48 weeks; 5) Quality of life (Qol) at 12, 24, 36 and 48 weeks. The safety objectives will be adverse events, adverse drug reactions, unexpected adverse reaction, suspected unexpected adverse reactions and death, across the study and at 12, 24, 36 and 48 weeks.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

The changing landscape of thyroid eye disease: current clinical advances and future outlook.
Moledina M, Damato EM, Lee V. · · 2024 · cited 37× · PMID 38374366 · DOI 10.1038/s41433-024-02967-9
Sirolimus as a second-line treatment for Graves' orbitopathy.
Lanzolla G, Maglionico MN, Comi S, Menconi F, et al · · 2022 · cited 32× · PMID 35831587 · DOI 10.1007/s40618-022-01862-y
Future Projections in Thyroid Eye Disease.
Barbesino G, Salvi M, Freitag SK. · · 2022 · cited 29× · PMID 36346684 · DOI 10.1210/clinem/dgac252
A Comprehensive Review of Thyroid Eye Disease Pathogenesis: From Immune Dysregulations to Novel Diagnostic and Therapeutic Approaches.
Kulbay M, Tanya SM, Tuli N, Dahoud J, et al · · 2024 · cited 18× · PMID 39519180 · DOI 10.3390/ijms252111628
Can chimeric antigen receptors - based therapy bring a gleam of hope for thyroid-associated ophthalmopathy and other autoimmune diseases?
Zhou W, Zhu X, Shi Y. · · 2025 · PMID 40838106 · DOI 10.1515/mr-2024-0099

Verify or expand the search:

Other trials of Sirolimus

Trials testing the same drug.

NCT07542314 — Study to Evaluate the Safety and Effectiveness of ELEVIDYS in Participants With Duchenne Muscular Dystrophy Treated in a · Phase 4 · not yet recruiting
NCT06876142 — Combination Therapy (Mirdametinib and Sirolimus) for RAS Mutated Relapsed Refractory Multiple Myeloma · Phase 1, PHASE2 · suspended
NCT07052929 — Study of ASP2957 in Male Participants With X-linked Myotubular Myopathy Who Need Ventilators · Phase 1, PHASE2 · recruiting
NCT04370795 — Matched Related and Unrelated Donor Stem Cell Transplantation for Severe Combined Immune Deficiency (SCID): Busulfan-bas · Phase 1, PHASE2 · withdrawn
NCT07162038 — Phase I Trial Integrating HLA-Haploidentical Anti-CD19 CAR-T Cells With Post-Transplantation Cyclophosphamide-Based HLA- · Phase 1 · recruiting

Other recruiting trials for Graves Ophthalmopathy

Currently open trials in the same condition.

NCT07480720 — Systemic Inflammation, Thyroid Autoimmunity and Neuroretinal Changes in Graves Disease · recruiting
NCT05126147 — Hydroxychloroquine in Mild Graves' Orbitopathy · Phase 4 · recruiting
NCT06275373 — The Effect of Teprotumumab on Thyroid Eye Disease and Thyroid Dysfunction · recruiting
NCT05678374 — Exploring Immunological Markers Associated With Mental Fatigue in Graves' Disease · recruiting
NCT03131726 — Treatment of Graves´ophthalmopathy with Simvastatin (GO-S) · Phase 3 · recruiting

Other University of Pisa trials

Trials by the same sponsor.

NCT07520890 — Oral Biopsy Bleeding in Patients on Direct Oral Anticoagulants (DOACs) · recruiting
NCT07444229 — Team-Based Learning Integrated Into Clinical Simulation in Nursing Students · NA · not yet recruiting
NCT07041983 — 24-h Energy Expenditure and Anti-obesity Medication · enrolling by invitation
NCT07510685 — Closed-System Bladder Irrigation to Reduce Urinary Tract Infections After Endoscopic Urologic Surgery (IRIS Trial) · NA · completed
NCT07055152 — Retinal OCTA for Microvascular Dysfunction Evaluation and Outcome Prediction in MINOCA Patients · 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 NCT04598815 (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 University of Pisa
Last refreshed: 15 March 2023

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/NCT04598815.

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