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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06976671




Registration number
NCT06976671
Ethics application status
Date submitted
10/09/2024
Date registered
16/05/2025

Titles & IDs
Public title
A Study to Determine the Safety and Efficacy of Bevacizumab Administered Via Injection Into the Shoulder Joint of Participants With Adhesive Capsulitis (Frozen Shoulder)
Scientific title
A Phase II Proof-of-concept Study Evaluating the Safety and Efficacy of Bevacizumab in the Treatment of Adhesive Capsulitis
Secondary ID [1] 0 0
MQ-SR-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adhesive Capsulitis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Bevacizumab

Experimental: Intra-articular Bevacizumab - Bevacizumab administered as a single-dose intra-articular injection at 4 dose levels (50mg, 100mg, 150mg, 200mg)


Treatment: Drugs: Bevacizumab
intra-articular bevacizumab
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluate the safety of bevacizumab over a 52-week period in participants with adhesive capsulitis
Timepoint [1] 0 0
52 Weeks
Primary outcome [2] 0 0
Determine the maximum tolerated dose of intra-articular bevacizumab at 1 week (V3) per cohort
Timepoint [2] 0 0
From start of treatment to 1 week after treatment
Secondary outcome [1] 0 0
Evaluate the efficacy of bevacizumab over a 52-week period in participants with adhesive capsulitis
Timepoint [1] 0 0
52 weeks
Secondary outcome [2] 0 0
Evaluate the efficacy of bevacizumab over a 52-week period in participants with adhesive capsulitis
Timepoint [2] 0 0
52 weeks
Secondary outcome [3] 0 0
Evaluate the efficacy of bevacizumab over a 52-week period in participants with adhesive capsulitis
Timepoint [3] 0 0
52 weeks
Secondary outcome [4] 0 0
Evaluate the efficacy of bevacizumab over a 52-week period in participants with adhesive capsulitis
Timepoint [4] 0 0
52 weeks
Secondary outcome [5] 0 0
Evaluate the efficacy of bevacizumab over a 52-week period in participants with adhesive capsulitis
Timepoint [5] 0 0
52 weeks

Eligibility
Key inclusion criteria
IC1. Over 18 years of age (inclusive) at the time of signing informed consent

IC2. Clinical diagnosis of adhesive capsulitis which is defined as:

1. Progressive pain and stiffness for a period greater than 2 months but less than 6 months; and,
2. Either thickening or signal hyperintensity associated with coracohumeral ligament, axillary pouch, or rotator interval joint capsule OR obliteration of the subcoracoid fat triangle as confirmed by radiological examination (magnetic resonance imaging); and,
3. Normal x-ray of the shoulder with no evidence of glenohumeral joint degenerative changes or sequelae of previous trauma.

IC3. Capable of giving signed informed consent as described in Section 14 of the protocol which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol

IC4. Participants of child-bearing potential are eligible to participate if they agree to the following during the study intervention period and for a minimum of 120 days after the study intervention is administered:

1. Female participants must not be pregnant or breastfeeding AND are either abstinent from heterosexual intercourse as their preferred usual lifestyle OR engage in an adequate method of contraception (i.e., the oral contraceptive pill, intrauterine device, or other)
2. Male participants must refrain from donating sperm AND are either abstinent from heterosexual intercourse as their preferred usual lifestyle OR must agree to use an adequate method of contraception/barrier method (i.e. condom and/or heterosexual partner engaging in an adequate method of contraception as previously described)

IC5. Participants who are not of child-bearing potential, defined as at least one or more of the following criteria, are eligible to participate in the study

1. Female participants in a post-menopausal state (defined as not experiencing menses for 12 consecutive months without an alternative cause)
2. Documented permanent sterilisation method (including, but not limited to, hysterectomy, bilateral salpingectomy, bilateral oophorectomy, and vasectomy)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
EC1. History of previous surgery or treatment with corticosteroid prior to screening, platelet-rich plasma, or anti-VEGF injections in the ipsilateral shoulder

EC2. History of adhesive capsulitis in ipsilateral shoulder

EC3. Presence of trauma in the affected shoulder unrelated to adhesive capsulitis

EC4 Advanced imaging features associated with calcific tendinopathy

EC5. Presence of uncontrolled hypertension (defined as systolic pressure > 140mmHg and diastolic pressure > 100mmHg)

EC6. Any medical history of cardiovascular disease, uncontrolled ischemic heart disease, acute myocardial infarction within 12 months of study entry, or any history of intracranial hemorrhage, stroke or a transient ischaemic attacks at any time

EC7. Presence of inflammatory arthritis (such as but not limited to: systemic lupus erythematosus, rheumatoid arthritis, reactive arthritis, etc.), Parkinson's disease, brain injury, osteoarthritis, bony glenohumeral pathology, hypothyroidism, neuromuscular disorders, or pre-diabetes or diabetes mellitus (defined by fasting glucose =7mmol/L and Hba1c = 5.7%)

EC8. Participants currently taking corticosteroids, monoclonal antibody therapy, or other immunosuppressants which are deemed to impact the study endpoints

EC9. Planning to or have received treatment for the affected shoulder at any time during the study or prior to the study included but not limited to:

1. Intra-articular or intrabursal injection(s) of lidocaine, suprascapular nerve blocks; corticosteroids, electroanalgesic and/or thermoanalgesic modalities
2. Intra-articular or intrabursal injection(s) of sodium hyaluronate and/or glenohumeral distension arthrography
3. Surgical intervention

EC10. Progressive pain and stiffness in the affected shoulder that is for a period less than 2 months or greater than 6 months

EC11. Hypersensitivity to the study intervention, including any constituents thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study

EC12. Any active malignancy under treatment

EC13. Women who are pregnant and/or breastfeeding, or who plan to be pregnant in the following six months after study intervention

EC14. Participants not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions that might affect their safety or ability to complete the protocol or that may confound the efficacy or safety results of the trial

EC15. Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals (in conjunction with Section 1.61 of the ICH-GCP Ordinance E6)

EC16. Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalised

EC17. Participants unable to provide written informed consent

EC18. Participants who have participated in other clinical trial within 1 month, have participated in another study within 6 months from the date of selection, or have planned for participation in another trial during the follow up period of this trial which is deemed by the Investigator to impact the planned study endpoints of this study

EC19. Acute illness within the 30 days prior to V1 that, in the opinion of the Investigator, affects the participant's ability to participate in the study.

EC20. Participants currently taking warfarin or any other anti-coagulation therapies.

EC21.Participants deemed with any condition which would preclude their use for study-related magnetic resonance imaging procedures, including but not limited to: morbid obesity, severe claustrophobia, and/or permanent pacemaker).

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/09/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2027
Actual
Sample size
Target
28
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Macquarie University - North Ryde
Recruitment postcode(s) [1] 0 0
2109 - North Ryde

Funding & Sponsors
Primary sponsor type
Other
Name
Macquarie University, Australia
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sumit Raniga, BSC, MSC, MBCHB, FRACS, FAORTH
Address 0 0
Macquarie Unniversity
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sumit Raniga, BSC, MSC, MBCHB, FRACS, FAORTH
Address 0 0
Country 0 0
Phone 0 0
+61 2 9812 3583
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06976671