Fibroblast markers to tackle fibrosis in immune-mediated inflammatory diseases

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Amsterdam UMC Stichting

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06], Diseases [C] - Immune System Diseases [C20], Diseases [C] - Respiratory Tract Diseases [C08], Diseases [C] - Skin and Connective Tissue Diseases [C17]

Decision date (initial)

2026-03-02

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Funding sources

TKI · AstraZeneca

External identifiers

EU CT number

2025-522834-30-01

WHO UTN

U1111-1325-0464

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Diagnosis, Pharmacokinetic

To evaluate the use of 68Ga-FAPi PET/CT imaging in detecting in vivo fibrosis and to correlate these findings to cellular and serum FAP levels in patients with IMIDs, and to identify other potential fibrotic biomarkers with diagnostic and/or therapeutic value for IMIDs.

Secondary objectives 1

1. Optimize the FAPi PET/CT scanning protocol for patients with connective tissue disease (SSc and IIM) and interstitial lung disease (FHP, uILD and IPF)

Conditions and MedDRA coding

Idiopathic inflammatory myopathy (IIM)

Regulatory references

Plan to share IPD

Yes

IPD plan description

Individual participant data (IPD) and study protocols will be shared upon reasonable request to the authors, starting 9 months after publication. Data will be anonymized and shared solely for legitimate research purposes. Access to data will require a formal request and approval, and data use will be subject to a data sharing agreement to ensure confidentiality and appropriate use.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. ≥ 18 years of age and able to undergo a PET/CT-scan and pulmonary function test (if applicable)
2. CD: endoscopically or ultrasonographically confirmed fibrostenotic disease with or without signs of active inflammation
3. UC: therapy-refractory UC requiring surgery or quiescent UC with surveillance endoscopy
4. SSc: SSc with active ILD or non-progressive ILD over two years or end-stage ILD
5. IIM: IIM with active myositis and a clinical need to start imunosupressive agents with or without ILD
6. FHP, uILD and IPF: available chest HRCT data within 12 months prior to screening (or performed at screening), minimum of 20% involvement of the lung parenchyma on HRCT and signs of fibrosis, FVC ≥ 45% predicted from normal, FEV1/FVC ≥ 0.7, DLco corrected for Hb ≥ 40% predicted from normal

Exclusion criteria 5

1. Pregnancy or lactating
2. Not able to provide written consent
3. Previous anti-fibrotic treatment except for end-stage ILD
4. IBD: colorectal carcinoma or high-grade dysplasia
5. ILD: combined pulmonary fibrosis and emphysema, uncontrolled severe asthma, active malignancy (except for squamous cell carcinoma of the skin, low-risk breast cancer and low-risk prostate cancer), signs of upper or lower respitory tract symptoms during the last 6 weeks before screening or circumstances or comorbidities which interfere, by opinion of the investigator, with evaluation of the PET/CT or with the evaluation of progressive pulmonary fibrosis

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Detection of areas with enhanced 68Ga-FAPi uptake in organs of patients with IBD, CTD or ILD and correlation of imaging outcomes to cellular and serum FAP expression levels
2. Transcriptome and proteome analysis of tissue samples for FAP and other potential fibrotic biomarkers as well as regulators of upstream signaling pathways and immune cell markers.

Secondary endpoints 2

1. Visual and semi-quantitative evaluation of the pharmacokinetics of 68GA-FAPi in patients with CTD and ILD.
2. Optimization of the 68Ga-FAPi PET/CT scanning protocol for patients with CTD and ILD.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Amsterdam UMC Stichting

Sponsor organisation

Amsterdam UMC Stichting

Address

De Boelelaan 1117

City

Amsterdam

Postcode

1081 HV

Country

Netherlands

Scientific contact point

Organisation

Amsterdam UMC Stichting

Contact name

M. Löwenberg

Public contact point

Organisation

Amsterdam UMC Stichting

Contact name

M. Löwenberg

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications