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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02328027
• Date of registration: 18/12/2014
• Prospective Registration: No
• Primary sponsor: Advanced Accelerator Applications
• Public title: 99mTc-rhAnnexin V-128 a Phase I/IIa Study in Patients With Rheumatoid Arthritis (RA) or Ankylosing Spondylitis (AS)
• Scientific title: A Phase I-IIa Study of Safety, Tolerance, Pharmacokinetics, Dosimetry and Benefice of Early Nuclear Medicine Imaging of 99mTc-rhAnnexin V-128 in Patients With Rheumatoid Arthritis or Ankylosing Spondylitis
• Date of first enrolment: December 11, 2014
• Target sample size: 16
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02328027
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Switzerland

Contacts

• Name: John Prior, MD, PhD
• Affiliation: CHUV Lausanne

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients diagnosed with RA based on ACR/EULAR 2010 criteria (score >=6), or Patients
diagnosed with AS based on the ASAS criteria. Patients with RA must have serology
assessment performed and documented at the time of enrollment.

- Patient with RA active disease (DAS > 2,6) and the introduction of a Bi-DMARD should
be indicated. RA patients must have been treated with DMARD (methotrexate, leflunomide
and sulfasalazine) or combination of these treatments for at least 3 months. Treatment
will be pursued while on study.

or RA patients must have been previously treated with Bi-DMARD before initiation of the new
Bi-DMARD treatment. The non-response of the previous Bi-DMARD treatment must be documented.

or Patients with AS with insufficiently controlled disease while under NSAID and indication
for Bi-DMARD. These patients must be under NSAID for at least 3 months and under the same
NSAID for at least 1 month prior to enrollment.

- = 18 years old

- Karnofsky = 80%

- Negative Pregnancy test for women with childbearing potential

- For women with childbearing potential, use of two reliable means of contraception
(e.g., hormonal contraceptive, patch, vaginal ring, intrauterine device, associated
with other barrier method of contraception such as the use of condoms) , throughout
their participation in the study

- Absence of ECG anomaly

- written ICF signed

Exclusion Criteria:

- Pregnancy or lactation

- Liver impairment (ALT, AST or Bilirubin > 2 ULN) at screening visit or baseline

- Kidney impairment (serum creatinine > 1.5 mg/dL)

- History of congestive heart failure (NYHA III & IV)

- History of malignant disease within 5 years

- History of any disease or relevant physical or psychiatric condition or abnormal
physical finding which may interfere with the study objectives at the investigator
judgment

- Known hypersensitivity to the investigational drug or any of its components

- Participation to another clinical trial within 4 weeks before study inclusion except
for patients who have participated or who are currently participating in an
interventional study without any study drug administration.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis

Rheumatoid Arthritis

Intervention(s)

Drug: 99mTc-rhAnnexin V-128

Primary Outcome(s)

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAE) and Death [Time Frame: From screening up to Day 90]

Secondary Outcome(s)

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

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

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

99mTc-rhAnnexin V-128 Blood Cpm Decay Corrected Data (Counts Per Minute in 1 mL Sample) [Time Frame: 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)]

99mTc-rhAnnexin V-128 Serum Cpm Decay Corrected Data (Counts Per Minute in 1 mL Sample) [Time Frame: 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)]

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

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

Number of Annexin Related Species as Assessed Size-Exclusion HPLC- High-Performance Liquid Chromatography (SEC-HPLC) Analysis [Time Frame: 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)]

Serum Concentration of rhAnnexin V-128 Based on Enzyme-linked Immunosorbent Assay (ELISA) Analysis [Time Frame: Day 1 (0 (Predose), 0.05, 0.10, 0.15, 0.30, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00 and 24.00 hours)]

Secondary ID(s)

1002

CAAA113A22101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 09/06/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02328027