NCT03232580

99mTc-rhAnnexin V-128 in Diagnosis of Spondyloarthritis

Phase II Study of 99mTc-rhAnnexin V-128 Radionuclide Imaging in Patients With Clinical Suspicion or Confirmed Diagnosis of Spondyloarthritis (SpA)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Advanced Accelerator Applications · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This single center, open-label, proof of concept (PoC) Phase II study aimed to assess the investigational imaging agent 99mTc-rhAnnexin V-128 in detecting spondyloarthritis (SpA) lesions. Overall, it was planned to recruit 20 adults with suspected or confirmed SpA. First, 5 patients were enrolled into a "proof of concept" phase, to assess the imaging potential of 99mTc-rhAnnexin V-128 in terms of imaging quality, disease-lesion radiotracer uptake and medical relevance. Based on these results the Data Monitoring Committee (DMC) was to decide whether to terminate the study or whether to continue and enroll the next 15 planned patients.

Detailed description

The study was prematurely terminated by the sponsor after the first 5 patients completed the PoC phase based on strategic considerations. Novartis acquired Advanced Accelerator Applications SA.

Conditions

• Spondyloarthritis

Interventions

Type	Name	Description
DRUG	rhAnnexin V-128	All patients received a single i.v injection of 99mTc-rhAnnexin V-128 at Day 0.

Timeline

• Start date: 2017-09-18
• Primary completion: 2018-11-12
• Completion: 2018-11-12
• First posted: 2017-07-28
• Last updated: 2019-12-13
• Results posted: 2019-12-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study