Long-term Follow-up Durability (Efficacy) Study of EN3835 for the Treatment of AC of the Shoulder (Frozen Shoulder)

Study Overview
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Brief Summary
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This is a long-term follow-up study to evaluate the safety and durability (efficacy) of response to EN3835 compared to placebo in participants who were treated in EN3835-210 or the pivotal Phase 3 parent studies for the treatment of AC of the shoulder (frozen shoulder).

Official Title
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An Observational, Double-blind (Sponsor Open), Long-term Study to Evaluate the Safety and Durability (Efficacy) of Response to EN3835 Compared to Placebo in the Treatment of Adhesive Capsulitis of the Shoulder (Frozen Shoulder)

Conditions
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Adhesive Capsulitis, Frozen Shoulder

Intervention / Treatment
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* Drug: Previously treated with EN3835 up to 1.74 mg or Placebo in EN3835-210 or the pivotal phase 3 studies


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have been enrolled and completed the EN3835-210 or pivotal Phase 3 parent studies (for Study EN3835-223 eligibility, completed participants are those who were assessed for safety and obtained ASES scores at Day 95/EOS Visit; does not include early terminated participants). Be willing not to use pain medications for the duration of the study period and for 2 weeks prior to the Day 180 visit. Pain medications include but are not limited to: barbiturates, benzodiazepines, methadone, buprenorphine, opioids (e.g., codeine, heroin, hydrocodone, hydromorphone, morphine, oxycodone), and cannabis. Note: NSAIDs (ibuprofen, etc.) are allowed. Be willing to undergo MRI of the affected shoulder as required by the protocol. Be able to read, understand, and independently complete patient reported outcome instruments in English. Be willing and able to cooperate with the requirements of the study. Be adequately informed and understand the nature and risks of the study and be able to provide consent. Exclusion Criteria: Is from a vulnerable population, as defined by the US Code of Federal Regulations (CFR) Title 45, Part 46, Section 46.111(b) and other local and national regulations, including but not limited to, employees (temporary, part-time, full time, etc.) or a family member of the research staff conducting the study, or of the sponsor, or of the contract research organization, or of the IRB/IEC. Plans to receive (or received prior to Day 180) any invasive or minimally invasive (ie, steroid injections, shoulder manipulation, surgery, etc.) procedures to the affected shoulder during study participation. Note: PT is allowed. Any PT received should be captured in the respective electronic case report form (eCRF). Has any contraindications for MRI (implant containing metal, internal metallic object, permanent cosmetics/make-up/tattoos-with exemption of the area to be treated/reviewed, claustrophobia, syncope, low blood pressure, epilepsy, asthma, anemia, or sickle cell disease) as determined by the technologist, the radiologist, and/or investigator performing imaging. Has any other conditions that, in the investigator's opinion, might indicate the participant to be unsuitable for the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EN3835<br>Previously treated with EN3835 in EN3835-210 or the pivotal phase 3 studies | Drug: Previously treated with EN3835 up to 1.74 mg or Placebo in EN3835-210 or the pivotal phase 3 studies<br>* No treatment to be administered - Observational only<br>|
| Placebo<br>Previously treated Placebo in EN3835-210 or the pivotal phase 3 studies | Drug: Previously treated with EN3835 up to 1.74 mg or Placebo in EN3835-210 or the pivotal phase 3 studies<br>* No treatment to be administered - Observational only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ASES composite score in affected shoulder | The change from Day 95/end of study (EOS) in the parent studies in the adapted American Shoulder and Elbow Society (ASES) composite score for the affected shoulder | Days 180, 270, and 360 |