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Adhesive CapsulitisPhase 2NCT06976671

A Study to Determine the Safety and Efficacy of Bevacizumab Administered Via Injection Into the Shoulder Joint of Participants With Adhesive Capsulitis (Frozen Shoulder)

A Phase 2 study testing Bevacizumab in people with Adhesive Capsulitis, run by Macquarie University, Australia at 1 site in Australia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study is intended to test a new treatment for a condition called adhesive capsulitis, also known as frozen shoulder. The treatment being tested is called bevacizumab. Participants will receive a single dose of bevacizumab (50mg, 100mg, 150mg, or 200mg) via injection into their shoulder joint. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Adhesive Capsulitis
What is being tested?
Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteAustralia
Study dates
10 Sep 2024to Sep 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • IC1. Over 18 years of age (inclusive) at the time of signing informed consent
  • IC2. Clinical diagnosis of adhesive capsulitis which is defined as:
  • Progressive pain and stiffness for a period greater than 2 months but less than 6 months; and,
  • 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,
  • 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
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  • 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:
  • 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)
  • 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
  • Female participants in a post-menopausal state (defined as not experiencing menses for 12 consecutive months without an alternative cause)
  • Documented permanent sterilisation method (including, but not limited to, hysterectomy, bilateral salpingectomy, bilateral oophorectomy, and vasectomy)

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sumit Raniga, BSC, MSC, MBCHB, FRACS, FAORTH contact

+61 2 9812 3583

sumit.raniga@mqhealth.org.au

Australia1 site, 1 recruiting
  • Macquarie University

    North Ryde, New South Wales, 2109

    Recruiting

Other trials in Australia

About this study

Official title: A Phase II Proof-of-concept Study Evaluating the Safety and Efficacy of Bevacizumab in the Treatment of Adhesive Capsulitis

This study is intended to test a new treatment for a condition called adhesive capsulitis, also known as frozen shoulder. The treatment being tested is called bevacizumab. Participants will receive a single dose of bevacizumab (50mg, 100mg, 150mg, or 200mg) via injection into their shoulder joint. After the injection, participants will return to site 6 times over the course of a year for safety assessments, questionnaires to track pain levels, and range of movement tests conducted by a physiotherapist.

The main goal of this study is to:

Read more
  1. Evaluate the safety and effectiveness of bevacizumab when it is injected into the frozen shoulder joint.
  2. Determine the maximum dose of bevacizumab that can be given without side effects.

This is an investigator initiated clinical trial sponsored by Macquarie University. There will be a maximum of 28 participants enrolled and the only site involved in recruitment is Macquarie University.

Read the detailed description

This study is a single-centred, open-label, dose-ranging clinical trial to assess the safety and efficacy of intra-articular bevacizumab in adults with adhesive capsulitis. Participants, aged 18 years and over, will be included in this study if they are diagnosed with adhesive capsulitis as defined in the inclusion criteria. Eligibility will be dependent on the exclusion of any previous shoulder trauma in the contralateral shoulder, previous adhesive capsulitis or any other differential diagnosis of the ipsilateral shoulder, and serology confirming absence of diabetes mellitus.

The dose-ranging follows a classic "3+3 design" to establish dose-limiting toxicities and the recommended dose for future studies. All dose escalations will be determined after a safety evaluation of the prior cohort. The design will be conducted as follows: initially, three participants will be enrolled into cohort 1 and will receive a 50mg dose of bevacizumab. The occurrence of a single treatment-related dose limiting toxicity (defined as a grade 3 or higher adverse event as per Common Terminology Criteria for Adverse Events version 5.0 [United States of Health and Human Services, 2017]) will prompt enrolment of three additional participants into the same cohort. When more than one treatment-related dose limiting toxicity occurs in ≤ 6 patients in a dosing cohort, dose escalation will be stopped, and this dose level will be identified as the non-tolerated dose. Otherwise, if ≤ 1 treatment-related dose limiting toxicity occurs in ≤ 6 participants, three participants will be enrolled into the next cohort (cohort 2) and receive a sequentially higher dose of bevacizumab (100mg). This will continue at 50mg increases of bevacizumab for each cohort unless otherwise stopped due to dose-limiting toxicities or Sponsor discretion. The maximum planned dose will be cohort 4 (200mg dose). For this cohort, it is planned to enroll up to 10 participants unless DLTs are observed or enrolment is stopped.

Being tested
Bevacizumab
Keywords
Adhesive Capsulitis, Frozen Shoulder
Medical subject headings
Bursitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06976671
Study groupRoleWhat they receive
Intra-articular BevacizumabExperimentalBevacizumab administered as a single-dose intra-articular injection at 4 dose levels (50mg, 100mg, 150mg, 200mg)
Receives: Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate the safety of bevacizumab over a 52-week period in participants with adhesive capsulitis

    • Incidence of adverse events (including medically significant changes in physical assessments, laboratory assessments, vital signs, and electrocardiogram), and serious adverse events, at 7 days (V3), 14 days (V4), 28 days (V5), 84 days (V6), 168 days (V7), and 364 days (V8)
    • Incidence of adverse events and serious adverse events at 3 days (V2)

    Measured: 52 Weeks

  2. Determine the maximum tolerated dose of intra-articular bevacizumab at 1 week (V3) per cohort

    Maximum tolerated dose as defined as the highest dose where 0 out of 3 participants or no more than 1 out of 6 participants experienced any dose-limiting toxicity (defined as a grade 3 or higher adverse event as per Common Terminology Criteria for Adverse Events version 5.0

    Measured: From start of treatment to 1 week after treatment

Secondary outcomes (5)
  1. Evaluate the efficacy of bevacizumab over a 52-week period in participants with adhesive capsulitis

    Change in passive global range of motion loss against contralateral shoulder at baseline (V1) versus 14 days (V4), 28 days (V5), 84 days (V6), 168 days (V7), and 364 days (V8)

    Measured: 52 weeks

  2. Evaluate the efficacy of bevacizumab over a 52-week period in participants with adhesive capsulitis

    Change in pain levels (assessed by a visual analogue scale: 0 to 100, higher score indicating worse outcome) at baseline (V1) versus 14 days (V4), 28 days (V5), 84 days (V6), 168 days (V7), and 364 days (V8).

    Measured: 52 weeks

  3. Evaluate the efficacy of bevacizumab over a 52-week period in participants with adhesive capsulitis

    Change in Shoulder Pain and Disability Index assessment (Roach, 1991) at baseline (V1) versus 14 days (V4), 28 days (V5), 84 days (V6), 168 days (V7), and 364 days (V8)

    Measured: 52 weeks

  4. Evaluate the efficacy of bevacizumab over a 52-week period in participants with adhesive capsulitis

    Change in Quick Disabilities of the Arm, Shoulder and Hand assessment (Work and Health, 2006) at baseline (V1) versus 14 days (V4), 28 days (V5), 84 days (V6), 168 days (V7), and 364 days (V8)

    Measured: 52 weeks

  5. Evaluate the efficacy of bevacizumab over a 52-week period in participants with adhesive capsulitis

    Categorical change in severity classification of global range of motion loss at baseline (V1) versus 14 days (V4), 28 days (V5), 84 days (V6), 168 days (V7), and 364 days (V8)

    Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2025
  2. Study start10 Sep 2024
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Participants will receive a single intra-articular dose of 50mg bevacizumab. This dose will increase sequentially by 50mg per treatment cohort, until otherwise stopped due to dose-limiting toxicities or Sponsor discretion. The dose-ranging follows a classic "3+3 design" to establish dose-limiting toxicities and the recommended dose for future studies. All dose escalations will be determined after a safety evaluation of the prior cohort. The design will be conducted as follows: initially, three participants will be enrolled into cohort 1 and will receive a 50mg dose of bevacizumab. The occurrence of a single treatment-related dose limiting toxicity will prompt enrolment of three additional participants into the same cohort. When more than one treatment-related dose limiting toxicity occurs in ≤ 6 patients in a dosing cohort, dose escalation will be stopped, and this dose level will be identified as the non-tolerated dose. Otherwise, if ≤ 1 treatment-related dose limiting toxicity occur
Masking
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06976671
Sponsor's protocol ID
MQ-SR-001
Status last verified
Sep 2024
First submitted
10 Sep 2024
Last updated
16 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab in people with Adhesive Capsulitis, run by Macquarie University, Australia at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sumit Raniga, BSC, MSC, MBCHB, FRACS, FAORTH (+61 2 9812 3583, sumit.raniga@mqhealth.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the safety of bevacizumab over a 52-week period in participants with adhesive capsulitis (time frame: 52 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.

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