99mTc-rhAnnexin V-128 in Diagnosis of Spondyloarthritis

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.

Timeline

Start

2017-09-18

Primary completion

2018-11-12

Completion

2018-11-12

Outcome

Outcome not reported

Stopped (Business): “Sponsor Decision based on strategic considerations.”

Drugs

Indications