NCT02328027 is a Phase 1, PHASE2 clinical trial of 99mTc-rhAnnexin V-128 in Rheumatoid Arthritis, sponsored by Advanced Accelerator Applications.

Who is sponsoring NCT02328027?

NCT02328027 is sponsored by Advanced Accelerator Applications.

What drugs are being tested in NCT02328027?

Interventions in NCT02328027: 99mTc-rhAnnexin V-128.

What condition does NCT02328027 study?

NCT02328027 studies Rheumatoid Arthritis, Ankylosing Spondylitis.

Is NCT02328027 still recruiting?

NCT02328027 is currently terminated. Last updated 8 October 2020.

Are results published for NCT02328027?

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

Last reviewed 2020-10-08 · How we verify

NCT02328027

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

99mTc-rhAnnexin V-128 a Phase I/IIa Study in Patients With Rheumatoid Arthritis (RA) or Ankylosing Spondylitis (AS)

Terminated Phase 1, PHASE2 Results posted Last updated 8 October 2020

What this trial tests

Phase 1, PHASE2 trial testing 99mTc-rhAnnexin V-128 in Rheumatoid Arthritis in 16 participants. Terminated before completion.

Timeline

11 December 2014

Primary endpoint
17 October 2017

17 October 2017

Quick facts

Lead sponsor	Advanced Accelerator Applications
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	16
Start date	11 December 2014
Primary completion	17 October 2017
Estimated completion	17 October 2017
Sites	1 location across Switzerland

Drugs / interventions tested

99mTc-rhAnnexin V-128 — full drug profile →

Conditions studied

Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →
Ankylosing Spondylitis — all drugs for Ankylosing Spondylitis →

Sponsor

Advanced Accelerator Applications — full company profile →

Who can join

18 and older, any sex, with Rheumatoid Arthritis or Ankylosing Spondylitis. 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.

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAE) and Death Primary · From screening up to Day 90

An adverse event (AE) is defined as any untoward medical occurrence in a patient and which does not necessarily have a causal relationship with the study medication. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease, temporally associated with the use of a study medication, whether or not causally related to the study medication. TEAEs are defined as all AEs reported after the first dose. An SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, life-threatening, results in persis

TEAEs

Group	Value	95% CI
99mTc-rhAnnexin V-128: Ankylosing Spondylitis	3
99mTc-rhAnnexin V-128: Rheumatoid Arthritis	11

SAEs

Group	Value	95% CI
99mTc-rhAnnexin V-128: Ankylosing Spondylitis	0
99mTc-rhAnnexin V-128: Rheumatoid Arthritis	1

Death

Group	Value	95% CI
99mTc-rhAnnexin V-128: Ankylosing Spondylitis	0
99mTc-rhAnnexin V-128: Rheumatoid Arthritis	0

Area Under the Curve Extrapolated to Infinity (AUC) of 99mTc-rhAnnexin V-128 Secondary · Day 1 (0 (Predose), 0.05, 0.10, 0.15, 0.30, 1.00, 1.50, 2.00, 4.00 and 24.00 hours)

AUC is defined as area under the curve extrapolated to infinity of 99mTc-rhAnnexin V-128.

Blood

Group	Value	95% CI
99mTc-rhAnnexin V-128: AS and RA	41.2	± 13.7

Serum

Group	Value	95% CI
99mTc-rhAnnexin V-128: AS and RA	53.6	± 22.6

Distribution Volume (Vz) of 99mTc-rhAnnexin V-128 Secondary · Day 1 (0 (Predose), 0.05, 0.10, 0.15, 0.30, 1.00, 1.50, 2.00, 4.00 and 24.00 hours)

Vz is defined as the distribution volume of 99mTc-rhAnnexin V-128.

Blood

Group	Value	95% CI
99mTc-rhAnnexin V-128: AS and RA	30.3	± 9.0

Serum

Group	Value	95% CI
99mTc-rhAnnexin V-128: AS and RA	26.1	± 11.5

Systemic Clearance (Cl) of 99mTc-rhAnnexin V-128 Secondary · Day 1 (0 (Predose), 0.05, 0.10, 0.15, 0.30, 1.00, 1.50, 2.00, 4.00 and 24.00 hours)

Cl is defined as the systemic clearance of 99mTc-rhAnnexin V-128.

Blood

Group	Value	95% CI
99mTc-rhAnnexin V-128: AS and RA	5.82	± 1.59

Serum

Group	Value	95% CI
99mTc-rhAnnexin V-128: AS and RA	4.68	± 1.67

Elimination Half-life (t1/2) of 99mTc-rhAnnexin V-128 Secondary · Day 1 (0 (Predose), 0.05, 0.10, 0.15, 0.30, 1.00, 1.50, 2.00, 4.00 and 24.00 hours)

t1/2 is defined as the elimination half-life of 99mTc-rhAnnexin V-128.

Blood

Group	Value	95% CI
99mTc-rhAnnexin V-128: AS and RA	3.6	± 0.2

Serum

Group	Value	95% CI
99mTc-rhAnnexin V-128: AS and RA	3.8	± 0.3

99mTc-rhAnnexin V-128 Blood Cpm Decay Corrected Data (Counts Per Minute in 1 mL Sample) Secondary · Day 1 (0 (Predose), 0.05, 0.10, 0.15, 0.30, 1.00, 1.50 to 2.00, 3.00 to 4.00 and 24.00 hours)

Total radioactivity count per minute in whole blood samples were reported.

0 (Predose)

Group	Value	95% CI
99mTc-rhAnnexin V-128: AS and RA	0.0	± 0.00

5 min

Group	Value	95% CI
99mTc-rhAnnexin V-128: AS and RA	1667814	± 209478

10 min

Group	Value	95% CI
99mTc-rhAnnexin V-128: AS and RA	1188917	± 162265

15 min

Group	Value	95% CI
99mTc-rhAnnexin V-128: AS and RA	976977	± 168240

30 min

Group	Value	95% CI
99mTc-rhAnnexin V-128: AS and RA	560111	± 183995

Group	Value	95% CI
99mTc-rhAnnexin V-128: AS and RA	270715	± 101320

1.5h to 2.0h

Group	Value	95% CI
99mTc-rhAnnexin V-128: AS and RA	140730	± 30842

3.0h to 4.0h

Group	Value	95% CI
99mTc-rhAnnexin V-128: AS and RA	64421	± 20850

99mTc-rhAnnexin V-128 Serum Cpm Decay Corrected Data (Counts Per Minute in 1 mL Sample) Secondary · Day 1 (0 (Predose), 0.05, 0.10, 0.15, 0.30, 1.00, 1.50 to 2.00, 3.00 to 4.00, 6.00 and 24.00 hours)

Total radioactivity count per minute in serum samples were reported.

Predose

Group	Value	95% CI
99mTc-rhAnnexin V-128: AS and RA	0.0	± 0.00

5 min

Group	Value	95% CI
99mTc-rhAnnexin V-128: AS and RA	2043946	± 654557

10 min

Group	Value	95% CI
99mTc-rhAnnexin V-128: AS and RA	1432102	± 453282

15 min

Group	Value	95% CI
99mTc-rhAnnexin V-128: AS and RA	1176933	± 299437

30 min

Group	Value	95% CI
99mTc-rhAnnexin V-128: AS and RA	719880	± 287310

Group	Value	95% CI
99mTc-rhAnnexin V-128: AS and RA	349309	± 103963

1.5h to 2.0h

Group	Value	95% CI
99mTc-rhAnnexin V-128: AS and RA	223067	± 51303

3.0h to 4.0h

Group	Value	95% CI
99mTc-rhAnnexin V-128: AS and RA	106070	± 31082

99mTc-rhAnnexin V-128 Urine Cpm Decay Corrected Data (Counts Per Minute in 1 mL Sample) Secondary · Day 1 (0 (Predose), 1.00, 4.00, 6.00 and 24.00 hours)

Total radioactivity count per minute in urine samples were reported.

0 (Predose)

Group	Value	95% CI
99mTc-rhAnnexin V-128: AS and RA	12	± 26

1 hour

Group	Value	95% CI
99mTc-rhAnnexin V-128: AS and RA	6613620	± 1786521

4 hours

Group	Value	95% CI
99mTc-rhAnnexin V-128: AS and RA	9135076	± 3248412

16 hours

Group	Value	95% CI
99mTc-rhAnnexin V-128: AS and RA	1517263	± 1180019

24 hours

Group	Value	95% CI
99mTc-rhAnnexin V-128: AS and RA	96155.2	± 84394.79

Number of Annexin Related Species as Assessed Size-Exclusion HPLC- High-Performance Liquid Chromatography (SEC-HPLC) Analysis Secondary · Day 1 (0 (Predose), up to 1.00 hour, from 1.00 to 4.00 hours, from 4.00 to 6.00 hours, from 16.00 to 24.00 hours)

Urine samples (10 mL aliquots) were analysed as a function of time by SEC-HPLC technique at the local laboratory in order to gain information on the chemical status of 99mTc-rhAnnexin V-128 and on the presence of 99mTc-rhAnnexin V-128-related species.

0 (Predose)-HPLC Performed?=Yes

Group	Value	95% CI
99mTc-rhAnnexin V-128: AS and RA	5
99mTc-rhAnnexin V-128: AS and RA	0

Up to 1 hour-HPLC Performed?=Yes

Group	Value	95% CI
99mTc-rhAnnexin V-128: AS and RA	5
99mTc-rhAnnexin V-128: AS and RA	0

From 1 to 4 hours-HPLC Performed?=Yes

Group	Value	95% CI
99mTc-rhAnnexin V-128: AS and RA	5
99mTc-rhAnnexin V-128: AS and RA	0

From 4 to 6 hours-HPLC Performed?=Yes

Group	Value	95% CI
99mTc-rhAnnexin V-128: AS and RA	5
99mTc-rhAnnexin V-128: AS and RA	0

From 16 to 24 hours-HPLC Performed?=Yes

Group	Value	95% CI
99mTc-rhAnnexin V-128: AS and RA	4
99mTc-rhAnnexin V-128: AS and RA	0

From 16 to 24 hours-HPLC Performed?=No

Group	Value	95% CI
99mTc-rhAnnexin V-128: AS and RA	0
99mTc-rhAnnexin V-128: AS and RA	1

Adverse events — posted to ClinicalTrials.gov

Time frame: From start of screening up to Day 90. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

99mTc-rhAnnexin V-128: Ankylosing Spondylitis

Serious: 0/5 (0%)

Deaths: 0/5

99mTc-rhAnnexin V-128: Rheumatoid Arthritis

Serious: 1/11 (9%)

Deaths: 0/11

Serious adverse events (1 terms)

Reaction	System	99mTc-rhAnnexin V-128: Ank…	99mTc-rhAnnexin V-128: Rhe…
Depression	Psychiatric disorders	—	—

Other adverse events (56 terms — click to expand)

Reaction	System	99mTc-rhAnnexin V-128: Ank…	99mTc-rhAnnexin V-128: Rhe…
Fatigue	General disorders	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Paraesthesia	Nervous system disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Influenza like illness	General disorders	—	—
Pyrexia	General disorders	—	—
Urinary tract infection	Infections and infestations	—	—
Angina pectoris	Cardiac disorders	—	—
Cyanosis	Cardiac disorders	—	—
Palpitations	Cardiac disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—
Dry mouth	Gastrointestinal disorders	—	—
Faeces discoloured	Gastrointestinal disorders	—	—
Haematochezia	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Chills	General disorders	—	—
Malaise	General disorders	—	—
Pain	General disorders	—	—
Cytokine release syndrome	Immune system disorders	—	—
Gastroenteritis	Infections and infestations	—	—
Infection	Infections and infestations	—	—
Nasopharyngitis	Infections and infestations	—	—
Fall	Injury, poisoning and procedural complications	—	—
Procedural dizziness	Injury, poisoning and procedural complications	—	—
Procedural pain	Injury, poisoning and procedural complications	—	—
Blood urine present	Investigations	—	—
Oxygen saturation decreased	Investigations	—	—
Weight decreased	Investigations	—	—
Weight increased	Investigations	—	—
Dehydration	Metabolism and nutrition disorders	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Joint swelling	Musculoskeletal and connective tissue disorders	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—
Muscular weakness	Musculoskeletal and connective tissue disorders	—	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—	—
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—
Cognitive disorder	Nervous system disorders	—	—

Most-reported serious reactions: Depression.

Data from ClinicalTrials.gov NCT02328027 adverse events section.

Sponsor's own description

This was a monocentric, open label, Phase I-IIa study. Eligible patients who signed the ICF received two single intravenous (IV) bolus of the imaging agent 99mTc-rhAnnexin V-128. The first dose was administered on Day 1, and the second dose on Day 42 (±2 weeks). All patients were to start a new disease modifying treatment for RA or AS on Day 2. This disease modifying treatment was at the discretion of the investigator and was not chosen by the sponsor. Safety was monitored at every visit. Whole body scintigraphic imaging was performed at Day 1 and Day 42 after 99mTc-rhAnnexin V-128 dosing. Clinical disease assessments were performed at screening, Day 42 and Day 90 to assess response to RA or AS treatment. Blood was drawn to test for 99mTc-rhAnnexin V-128 immunogenicity at screening and on Days 30, 56 and 90. Patients participating in the pharmacokinetic (PK)/dosimetric sub-study had additional assessments in the 24 hours following the Day 1 dose of 99mTc-rhAnnexin V-128.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

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Other recruiting trials for Rheumatoid Arthritis

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Other Advanced Accelerator Applications trials

Trials by the same sponsor.

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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 NCT02328027 (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: 8 October 2020

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/NCT02328027.

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

NCT02328027

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (1 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of 99mTc-rhAnnexin V-128

Other recruiting trials for Rheumatoid Arthritis

Other Advanced Accelerator Applications trials

Verify against primary sources