NCT03232580 (Annexin 03) is a Phase 2 clinical trial of rhAnnexin V-128 in Spondyloarthritis, sponsored by Advanced Accelerator Applications.

Who is sponsoring NCT03232580?

NCT03232580 is sponsored by Advanced Accelerator Applications.

What drugs are being tested in NCT03232580?

Interventions in NCT03232580: rhAnnexin V-128.

What condition does NCT03232580 study?

NCT03232580 studies Spondyloarthritis.

Is NCT03232580 still recruiting?

NCT03232580 is currently terminated. Last updated 13 December 2019.

Are results published for NCT03232580?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-12-13 · How we verify

NCT03232580: Annexin 03

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

99mTc-rhAnnexin V-128 in Diagnosis of Spondyloarthritis

Terminated Phase 2 Results posted Last updated 13 December 2019

What this trial tests

Phase 2 trial testing rhAnnexin V-128 in Spondyloarthritis in 5 participants. Terminated before completion.

Timeline

18 September 2017

Primary endpoint
12 November 2018

12 November 2018

Quick facts

Lead sponsor	Advanced Accelerator Applications
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	5
Start date	18 September 2017
Primary completion	12 November 2018
Estimated completion	12 November 2018
Sites	1 location across United States

Drugs / interventions tested

rhAnnexin V-128 — full drug profile →

Conditions studied

Spondyloarthritis — all drugs for Spondyloarthritis →

Sponsor

Advanced Accelerator Applications — full company profile →

Who can join

18 and older, any sex, with Spondyloarthritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

99mTc-rhAnnexin V-128 Uptake Primary · 60 minutes and 120 minutes post investigational product adminstration

In order to asses 99mTc-rhAnnexin V-128 magnitude and dynamic range of uptake within areas affected by inflammation, Single-Photon Emission Computed Tomography (SPECT)/Computed Tomography (CT) scans were interpreted and graded by at least two independent experienced nuclear medicine physicians blinded from clinical data and other imagings modality results. Uptake compared with background (e.g. physiological liver uptake) were assessed for each affected area by nuclear medicine physicians using a 4-grade scoring system (e.g. 0, none; 1, mild or present but \< to background uptake; 2, moderate

60 minutes: Whole Body Planar - Principal Inv.

Group	Value	95% CI
rhAnnexin V-128	2
rhAnnexin V-128	1
rhAnnexin V-128	2
rhAnnexin V-128	0

60 minutes: Whole Body Planar - Reviewer 1

Group	Value	95% CI
rhAnnexin V-128	5
rhAnnexin V-128	0
rhAnnexin V-128	0
rhAnnexin V-128	0

60 minutes: Whole Body Planar - Reviewer 2

Group	Value	95% CI
rhAnnexin V-128	3
rhAnnexin V-128	2
rhAnnexin V-128	0
rhAnnexin V-128	0

120 minutes: Whole Body Planar - Principal Inv.

Group	Value	95% CI
rhAnnexin V-128	1
rhAnnexin V-128	2
rhAnnexin V-128	1
rhAnnexin V-128	0

120 minutes: Whole Body Planar - Reviewer 1

Group	Value	95% CI
rhAnnexin V-128	5
rhAnnexin V-128	0
rhAnnexin V-128	0
rhAnnexin V-128	0

120 minutes: Whole Body Planar - Reviewer 2

Group	Value	95% CI
rhAnnexin V-128	3
rhAnnexin V-128	2
rhAnnexin V-128	0
rhAnnexin V-128	0

60 minutes: Abdomen - Principal Inv.

Group	Value	95% CI
rhAnnexin V-128	4
rhAnnexin V-128	1
rhAnnexin V-128	0
rhAnnexin V-128	0

60 minutes: Abdomen - Reviewer 1

Group	Value	95% CI
rhAnnexin V-128	5
rhAnnexin V-128	0
rhAnnexin V-128	0
rhAnnexin V-128	0

99mTc-rhAnnexin V-128 Uptake Adjudication Primary · 60 minutes and 120 minutes post investigational product adminstration

In order to asses 99mTc-rhAnnexin V-128 magnitude and dynamic range of uptake within areas affected by inflammation, Single-Photon Emission Computed Tomography (SPECT)/Computed Tomography (CT) scans were interpreted and graded by at least two independent experienced nuclear medicine physicians blinded from clinical data and other imagings modality results. In case of discrepancies between the different readers, an adjudication process based on consensus was put in place in order to obtain one final outcome for each area. Adjudication results were categorized as Positive or Negative. Only desc

Whole Body Planar - 60 minutes

Group	Value	95% CI
rhAnnexin V-128	1
rhAnnexin V-128	4

Whole Body Planar - 120 minutes

Group	Value	95% CI
rhAnnexin V-128	2
rhAnnexin V-128	3

Abdomen - 60 minutes

Group	Value	95% CI
rhAnnexin V-128	0
rhAnnexin V-128	5

Abdomen - 120 minutes

Group	Value	95% CI
rhAnnexin V-128	0
rhAnnexin V-128	5

Lumbosacral - 60 minutes

Group	Value	95% CI
rhAnnexin V-128	2
rhAnnexin V-128	3

Lumbosacral - 120 minutes

Group	Value	95% CI
rhAnnexin V-128	2
rhAnnexin V-128	3

Sacroiliac - 60 minutes

Group	Value	95% CI
rhAnnexin V-128	1
rhAnnexin V-128	4

Sacroiliac - 120 minutes

Group	Value	95% CI
rhAnnexin V-128	1
rhAnnexin V-128	4

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event were collected from first dosing (single administration, Day 0) plus 30 days post-treatment.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

rhAnnexin V-128

Serious: 0/5 (0%)

Deaths: 0/5

Other adverse events (4 terms — click to expand)

Reaction	System	rhAnnexin V-128
Nausea	Injury, poisoning and procedural complications	—
Itching at injection site	Injury, poisoning and procedural complications	—
Redness at injection site	Injury, poisoning and procedural complications	—
Head cold	Respiratory, thoracic and mediastinal disorders	—

Data from ClinicalTrials.gov NCT03232580 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Spondyloarthritis

Currently open trials in the same condition.

NCT06776965 — Ultra Processed Foods Consumption and Impact in Rheumatic Diseases. · recruiting
NCT06462937 — A Digital Exercise Intervention in Patients With Spondyloarthritis · NA · recruiting
NCT05879419 — Recombinant Herpes Zoster Vaccine in Patients With Autoimmune Rheumatic Diseases · Phase 4 · active not recruiting
NCT05290363 — The Role of IL-23 in Chronic Inflammatory Disease: Exploring the Cellular and Molecular Targets of IL-23 Signaling in Pe · NA · recruiting
NCT03983473 — Identification of Fecal Microbiota Biomarkers of Spondyloarthritis in Patients Suffering From Crohn's Disease. · NA · recruiting

Other Advanced Accelerator Applications trials

Trials by the same sponsor.

NCT04711135 — Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With GEP-NETs and PPGLs · Phase 2 · active not recruiting
NCT04524442 — Post-Authorization Safety Study (PASS) of LysaKare® in Adult Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET) Patie · Phase 4 · completed
NCT03972488 — Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET · Phase 3 · active not recruiting
NCT03872778 — [177Lu]-NeoB in Patients With Advanced Solid Tumors and With [68Ga]-neoB Lesion Uptake · Phase 1, PHASE2 · completed
NCT03691064 — Post-Authorization Long-Term Safety Study of LUTATHERA · active not 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 NCT03232580 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Advanced Accelerator Applications
Last refreshed: 13 December 2019

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/NCT03232580.

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