99mTc-rhAnnexin V-128 in Diagnosis of Spondyloarthritis

NCT03232580 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: AAA-Annexin-03CAAA113A22201
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spondyloarthritis

Keywords

Suspicion or confirmed diagnosis of Spondyloarthritis; Ankylosing Spondylarthritis; Ankylosing Spondylitis; Ankylosing Spondyloarthritis; Rheumatoid Spondylitis; Spondylarthritis Ankylopoietica; Spondylitis Ankylopoietica; Spondyloarthritis Ankylopoietica; Autoimmune systemic rheumatic disease; Inflammatory bowel disease; Psoriatic arthritis; Undifferentiated spondyloarthropathy.

Outcome Measures

Primary Outcomes (2)

• 99mTc-rhAnnexin V-128 Uptake

  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 or = to background uptake; 3, intense or \> to background uptake). Only descriptive analysis performed.

  60 minutes and 120 minutes post investigational product adminstration

• 99mTc-rhAnnexin V-128 Uptake Adjudication

  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 descriptive analysis performed.

  60 minutes and 120 minutes post investigational product adminstration

Study Arms (1)

rhAnnexin V-128

EXPERIMENTAL

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

Drug: rhAnnexin V-128

Interventions

rhAnnexin V-128 DRUG

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

rhAnnexin V-128

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For the first 5 patients enrolled in the POC part:
• \. Patients with clinical suspicion or confirmed diagnosis of SpA, based on the ASA criteria with active symptoms including back, hip or buttock pain prior to:
• A change in NSAID therapy or
• A change in non-biologic DMARD or
• A start of non-biologic DMARD.
• For the next 15 patients enrolled in the Phase II part:
• Patients with clinical suspicion or confirmed diagnosis of SpA, based on the ASAS criteria with active symptoms including back, hip or buttock pain prior to:
• A change in NSAIDs therapy
• A change in non-biologic DMARD
• A start of non-biologic DMARD
• A start of biologic DMARD
• For all patients:
• Age over 18 years old.
• Signed Informed Consent Form

You may not qualify if:

• 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 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
• Contraindication(s) to the MRI procedure (claustrophobia, prosthetic valve, pacemaker, inability to lie still in a supine position)

Sponsors & Collaborators

• Advanced Accelerator Applications: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Spondylarthritis; Spondylitis, Ankylosing; Inflammatory Bowel Diseases; Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Axial Spondyloarthritis; Spondylarthropathies; Ankylosis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

After the first 5 patients completed the Proof of Concept (PoC) phase, the study was terminated based on strategic considerations.

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2017
• First Posted: July 28, 2017
• Study Start: September 18, 2017
• Primary Completion: November 12, 2018
• Study Completion: November 12, 2018
• Last Updated: December 13, 2019
• Results First Posted: December 13, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)