Study to Evaluate the Efficacy and Safety of FX006 in Patients With Glenohumeral Osteoarthritis or Shoulder Adhesive Capsulitis

• Sponsor: Flexion Therapeutics, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT04160091
• Collaborator: Medpace, Inc. (Industry)
• Enrollment: 19
• Locations: 27
• Arms: 4
• Actual Duration (Months): 7.3
• Patients Per Site: 0.7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This is a double-blind study to evaluate the efficacy and safety of FX006 in patients with glenohumeral osteoarthritis (OA) or shoulder adhesive capsulitis (AC).

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis of the Shoulder; Adhesive Capsulitis	Drug: FX006; Drug: Normal Saline	Phase 2

Detailed Description

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study in separate cohorts of patients with a documented history of either glenohumeral OA or shoulder AC. Glenohumeral OA and shoulder AC patients will be randomized to receive a single intra-articular injection of either FX006 or placebo (saline) in a 1:1 ratio to the index shoulder with a 24-week Treatment Evaluation Period. Glenohumeral OA patients will be stratified by Baseline average daily shoulder pain with movement score according to the following classifications: 5.0 to <7.0 or ≥7.0 to 9.0 (0 to 10 numeric rating scale [NRS]). Shoulder AC patients will be stratified by Baseline average daily shoulder pain with movement score according to the following classifications: 5.0 to <7.0 or ≥7.0 to 9.0 (0 to 10 NRS), and by pain duration since onset (1 to 3 months, inclusive, or >3 to ≤6 months). A Home Exercise Program will be implemented 3 days following injection for shoulder AC patients.

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of FX006 in Patients With Glenohumeral Osteoarthritis or Shoulder Adhesive Capsulitis (RANGE)
• Actual Study Start Date: Nov 7, 2019
• Actual Primary Completion Date: Jun 15, 2020
• Actual Study Completion Date: Jun 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FX006 32mg in Glenohumeral OA Population Single intra-articular (IA) injection	Drug: FX006; Single intra-articular injection; Other Names: Zilretta
Placebo Comparator: Normal Saline in Glenohumeral OA Population Single intra-articular (IA) injection	Drug: Normal Saline; Single intra-articular injection
Experimental: FX006 32mg in Adhesive Capsulitis Population Single intra-articular (IA) injection	Drug: FX006; Single intra-articular injection; Other Names: Zilretta
Placebo Comparator: Normal Saline in Adhesive Capsulitis Population Single intra-articular (IA) injection	Drug: Normal Saline; Single intra-articular injection

Outcome Measures

Primary Outcome Measures

1. Area Under the Curve of the Change From Baseline in the Weekly Mean of the Daily Shoulder Pain With Movement [Baseline to 8 weeks]

   The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "No pain" and 10 indicates "Worst possible pain."

Secondary Outcome Measures

1. Change From Baseline in the Weekly Mean of the Average Daily Shoulder Pain With Movement Score [Baseline to 12 weeks]

   The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "No pain" and 10 indicates "Worst possible pain."

2. Change From Baseline in the SPADI Pain Subscale at Week 12 [Baseline to 12 weeks]

   Shoulder Pain and Disability Index (SPADI) Pain scale is measured using 5 11-point NRS questions where 0 indicates "no pain" and 10 indicates "worst pain imaginable." The Pain and Disability Subscales are presented as a percentage of the total possible score. The Total SPADI score ranges from 0 (best) to 100 (worst) is computed by taking the means of the Pain and Disability Subscale scores.

3. Change From Baseline in the SPADI Disability Subscale at Week 12 [Baseline to 12 weeks]

   Shoulder Pain and Disability Index (SPADI) Disability scale is measured using 8 11-point NRS questions where 0 indicates "no difficulty" and 10 indicates "so difficult it requires help." The Pain and Disability Subscales are presented as a percentage of the total possible score. The Total SPADI score ranges from 0 (best) to 100 (worst) is computed by taking the means of the Pain and Disability Subscale scores.

4. Patient Global Impression of Change (PGIC) Score at Week 12 [Baseline to 12 weeks]

   PGIC is measured using a 7-point NRS where 1 indicates "very much improved" and 7 indicates "very much worse."

5. Change From Baseline in the Range of Motion (ROM) of Active External Rotation at Week 12 [Baseline to 12 weeks]

   Measured using a goniometer which is a device that measures ROM joint angles

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Glenohumeral OA:

• Male or female, 35 to 80 years of age, inclusive, on the day of consent.

• Painful symptoms associated with OA of the index glenohumeral joint for ≤3 months prior to the Screening Visit.

• Grade 2 or 3 OA in the index glenohumeral joint based on the Samilson-Prieto classification system as confirmed by X-ray (axillary view and true anterior-posterior view) taken at the Screening Visit.

Shoulder AC:

• Male or female, 35 to 80 years of age, inclusive, on the day of consent.

• Pain associated with AC of the index joint for ≥1 month but ≤ 6 months prior to the Screening Visit.

• Limitations on both active and passive ROM ≥25% in at least 2 directions (e.g., forward flexion, abduction, and internal and external rotation assessed in a standardized protocol) compared with the contralateral shoulder or with normal values.

• No X-ray evidence of OA of the index shoulder (axillary view and true anterior-posterior view) at the Screening Visit.

• Agrees to complete a standardized, protocol-specified shoulder Home Exercise Program (HEP) starting 3 days after injection until the End of Study (EOS) Visit.

Both:

• Written consent to participate in the study

• Willing and able to comply with the study procedures and visit schedules and able to follow verbal and written instructions

• (BMI) ≤ 40 kg/m2

• Average daily mean shoulder pain with movement score ≥5.0 and ≤9.0 in the index shoulder (0 to 10 NRS) using the average daily ratings for at least 5 out of the 7 days prior to Day 1.

• Shoulder pain present >15 days in the month prior to the Screening Visit

• Willing to complete a washout of protocol-specified excluded medications 7 days prior to Day 1 and abstain from use of protocol-specified excluded medications throughout the study

• Willing to abstain from nonpharmacological therapies for the index joint for 2 weeks prior to Day 1 and throughout the study.

Exclusion Criteria:

• Has both glenohumeral OA and shoulder AC

• Has bilateral AC

• Has bilateral glenohumeral OA with glenohumeral OA pain of the shoulder contralateral to the index shoulder >3.0 (0 to 10 NRS) within 1 month prior to the Screening Visit

• Has a history of arthritis in other joints of the index shoulder (as confirmed by medical history and physical exam)

• Has a history or suspicion of full thickness rotator cuff tear in the index shoulder within 6 months of the Screening Visit

• Has symptomatic partial rotator cuff tear, tendinopathy, tendonitis, or bursitis in the index shoulder within 6 months of the Screening Visit

• Has a subchondral bone insufficiency fracture or humeral head necrosis/collapse in the index shoulder

• Shoulder AC patients only: Has a history of shoulder surgery or radiotherapy

• Glenohumeral OA patients only: Has a previous shoulder injury with functional limitation ≥1 month or surgery within 52 weeks of the Screening Visit

• Has an index shoulder with major dysplasia or congenital abnormality, osteochondritis dissecans, acromegaly, ochronosis, hemochromatosis, Wilson's disease, or primary osteochondromatosis, or a history of avascular necrosis with secondary OA

• Has current or history of infection in the index shoulder or current skin infection at injection site

• Has a concurrent chronic pain condition with a pain score >3.0 (0 to 10 NRS) within 1 month prior to the Screening Visit

• Has a history or current evidence of reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease, systemic lupus erythematosus, calcium pyrophosphate dihydrate crystal deposition disease (CPPD), or other autoimmune diseases

• Has any planned surgeries in the upper limbs during the study or any other surgery during the study that would require use of a restricted medication

• Has surgical hardware or other foreign body present in the index shoulder

• Has received an IA corticosteroid of any joint within 3 months of the Screening Visit

• Has received an IA treatment of the index shoulder with any of the following agents within 6 months of the Screening Visit

• Has received intravenous (IV), intrabursal, intratendinous, intramuscular (IM) or epidural corticosteroids within 3 months of the Screening Visit

• Has received oral corticosteroids within 1 month of the Screening Visit

• Has received inhaled, intranasal, or topical corticosteroids within 2 weeks of the Screening Visit

• Has had significant changes to lifestyle with regard to physical activity and lifestyle within 1 month of the Screening Visit or any planned changes throughout the duration of the study

• Has known hypersensitivity to TA or PLGA

• Has laboratory evidence of infection with (HIV), a positive test for hepatitis B surface antigen (HBsAg), or positive serology for hepatitis C virus (HCV) with positive test for HCV ribonucleic acid

• Has an electrocardiogram (ECG) abnormality

• Has uncontrolled diabetes as indicated by a hemoglobin A1c of >8% (>59 mmol/mol).

• Has a history of sarcoidosis or amyloidosis

• Has a history of or active Cushing's syndrome

• Has used chemotherapeutic agents, immunomodulators, or immunosuppressants within 5 years of the Screening Visit

• Has current or history of malignancy within 5 years prior to the Screening Visit, except for basal or squamous cell carcinoma of the skin or cervical carcinoma in situ that has been treated successfully.

• Has active substance use disorder or history of substance use disorder within 12 months prior to the Screening Visit

• Has received a live or live attenuated vaccine within 3 months of the Screening Visit

• Has used any other investigational drug, biologic, or device within 3 months of the Screening Visit

• Has any infection requiring IV antibiotics 4 weeks prior to Day 1 or oral antibiotics 2 weeks prior to Day 1

• Has a contraindication to the use of acetaminophen

• Is a female that is pregnant or nursing or plans to become pregnant during the study; or is a male who plans to inseminate a partner or donate sperm during the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Central Research Associates	Birmingham	Alabama	United States	35205
2	Alabama Clinical Therapeutics, LLC	Birmingham	Alabama	United States	35235
3	Affinity Orthopedic Specialists	Birmingham	Alabama	United States	35243
4	Coastal Clinical Research, Inc.	Mobile	Alabama	United States	36608
5	Arizona Research Center	Phoenix	Arizona	United States	85053
6	Tucson Orthopaedic Institute	Tucson	Arizona	United States	85712
7	TriWest Research Associates	El Cajon	California	United States	92020
8	CORE Orthopedic Medical Center	Encinitas	California	United States	92924
9	BioSolutions Clinical Research Center	La Mesa	California	United States	91924
10	Mountain View Clinical Research Center	Denver	Colorado	United States	80209
11	Coastal Orthopaedics and Sports Medicine	Bradenton	Florida	United States	34209
12	South Lake Pain Institute	Clermont	Florida	United States	34711
13	Universal Axon Clinical Research	Homestead	Florida	United States	33030
14	Precision Clinical Research	Lauderdale Lakes	Florida	United States	33319
15	Infinite Clinical Research	Miami	Florida	United States	33133
16	Jewitt Orthopedic Center	Orlando	Florida	United States	32822
17	Gulfcoast Research Institute	Sarasota	Florida	United States	34232
18	Better Health Clinical Research, Inc.	Newnan	Georgia	United States	30265
19	Professional Research Network of Kansas, LLC	Wichita	Kansas	United States	67205
20	Arthritis and Rheumatism Associates PC	Wheaton	Maryland	United States	20902
21	Hassman Research Institute	Berlin	New Jersey	United States	08009
22	M3 Emerging Medical Research	Durham	North Carolina	United States	22704
23	University Orthopedics Center	Altoona	Pennsylvania	United States	16602
24	Altoona Center for Clinical Research	Duncansville	Pennsylvania	United States	16635
25	Texas Orthopedic Specialists	Bedford	Texas	United States	76021
26	Centex Studies, Inc.	Houston	Texas	United States	77058
27	Spectrum Medical, Inc.	Danville	Virginia	United States	24541

Sponsors and Collaborators

• Flexion Therapeutics, Inc.
• Medpace, Inc.

Investigators

• Study Director: Scott Kelley, MD, Flexion Therapeutics, Inc.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 16, 2019

More Information

Publications

None provided.

• Responsible Party: Flexion Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT04160091
• Other Study ID Numbers: FX006-2018-016
• First Posted: Nov 12, 2019
• Last Update Posted: Nov 30, 2021
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Flexion Therapeutics, Inc.: Osteoarthritis; Adhesive Capsulitis; Shoulder; Pain; Intra-articular; Injection; Steroid
• Additional relevant MeSH terms: Osteoarthritis; Bursitis; FX006

Study Results

Participant Flow

Arm/Group Title	FX006 32mg in Glenohumeral OA Population	Normal Saline in Glenohumeral OA Population	FX006 32mg in Adhesive Capsulitis Population	Normal Saline in Adhesive Capsulitis Population
Arm/Group Description	Single intra-articular (IA) injection FX006: Single intra-articular injection	Single intra-articular (IA) injection Normal Saline: Single intra-articular injection	Single intra-articular (IA) injection FX006: Single intra-articular injection	Single intra-articular (IA) injection Normal Saline: Single intra-articular injection
Period Title: Overall Study
STARTED	7	3	5	4
COMPLETED	0	0	0	0
NOT COMPLETED	7	3	5	4

Baseline Characteristics

Arm/Group Title	FX006 32mg in Glenohumeral OA Population	Normal Saline in Glenohumeral OA Population	FX006 32mg in Adhesive Capsulitis Population	Normal Saline in Adhesive Capsulitis Population	Total
Arm/Group Description	Single intra-articular (IA) injection FX006: Single intra-articular injection	Single intra-articular (IA) injection Normal Saline: Single intra-articular injection	Single intra-articular (IA) injection FX006: Single intra-articular injection	Single intra-articular (IA) injection Normal Saline: Single intra-articular injection	Total of all reporting groups
Overall Participants	7	3	5	4	19
Age (years) [Mean (Standard Deviation) ]
OA Population	61.7 (13.07)	60.0 (2.65)	61.2 (10.78)
Adhesive Capsulitis Population	56.2 (12.64)	58.5 (4.80)	57.2 (9.48)
Sex: Female, Male (Count of Participants)
Female	1 14.3%	1 33.3%	2 40%
Male	6 85.7%	2 66.7%	8 160%
Female	4 57.1%	3 100%	7 140%
Male	1 14.3%	1 33.3%	2 40%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 14.3%	0 0%	1 20%
Not Hispanic or Latino	6 85.7%	3 100%	9 180%
Unknown or Not Reported	0 0%	0 0%	0 0%
Hispanic or Latino	1 14.3%	0 0%	1 20%
Not Hispanic or Latino	4 57.1%	4 133.3%	8 160%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 14.3%	1 33.3%	2 40%
White	6 85.7%	1 33.3%	7 140%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	1 33.3%	1 20%
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 14.3%	0 0%	1 20%
White	4 57.1%	4 133.3%	8 160%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	7 100%	3 100%	5 100%	4 100%	19 100%
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
OA Population	28.95 (2.473)	30.61 (3.744)	29.45 (2.799)
Adhesive Capsulitis Population	33.03 (4.425)	27.99 (6.752)	30.79 (5.826)

Outcome Measures

1. Primary Outcome

Title	Area Under the Curve of the Change From Baseline in the Weekly Mean of the Daily Shoulder Pain With Movement
Description	The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "No pain" and 10 indicates "Worst possible pain."
Time Frame	Baseline to 8 weeks

Outcome Measure Data

Analysis Population Description

Due to the early termination of the study, this endpoint was not analyzed. Change from baseline in the weekly mean of the average daily shoulder pain with movement score is included in Outcome Measure 2

Arm/Group Title	FX006 32mg in Glenohumeral OA Population	Normal Saline in Glenohumeral OA Population	FX006 32mg in Adhesive Capsulitis Population	Normal Saline in Adhesive Capsulitis Population
Arm/Group Description	Single intra-articular (IA) injection FX006: Single intra-articular injection	Single intra-articular (IA) injection Normal Saline: Single intra-articular injection	Single intra-articular (IA) injection FX006: Single intra-articular injection	Single intra-articular (IA) injection Normal Saline: Single intra-articular injection
Measure Participants	0	0	0	0

2. Secondary Outcome

Title	Change From Baseline in the Weekly Mean of the Average Daily Shoulder Pain With Movement Score
Description	The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "No pain" and 10 indicates "Worst possible pain."
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

All patients who received a dose of study drug assigned to the FX006 32 mg and the Placebo arm were included in the analysis.

Arm/Group Title	FX006 32mg in Glenohumeral OA Population	Normal Saline in Glenohumeral OA Population	FX006 32mg in Adhesive Capsulitis Population	Normal Saline in Adhesive Capsulitis Population
Arm/Group Description	Single intra-articular (IA) injection FX006: Single intra-articular injection	Single intra-articular (IA) injection Normal Saline: Single intra-articular injection	Single intra-articular (IA) injection FX006: Single intra-articular injection	Single intra-articular (IA) injection Normal Saline: Single intra-articular injection
Measure Participants	7	2	5	2
Mean (Standard Deviation) [score on a scale]	-3.54 (2.477)	-0.88 (1.237)	-4.05 (2.648)	-1.58 (2.003)

3. Secondary Outcome

Title	Change From Baseline in the SPADI Pain Subscale at Week 12
Description	Shoulder Pain and Disability Index (SPADI) Pain scale is measured using 5 11-point NRS questions where 0 indicates "no pain" and 10 indicates "worst pain imaginable." The Pain and Disability Subscales are presented as a percentage of the total possible score. The Total SPADI score ranges from 0 (best) to 100 (worst) is computed by taking the means of the Pain and Disability Subscale scores.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

All patients who received a dose of study drug assigned to the FX006 32 mg and the Placebo arm were included in the analysis.

Arm/Group Title	FX006 32mg in Glenohumeral OA Population	Normal Saline in Glenohumeral OA Population	FX006 32mg in Adhesive Capsulitis Population	Normal Saline in Adhesive Capsulitis Population
Arm/Group Description	Single intra-articular (IA) injection FX006: Single intra-articular injection	Single intra-articular (IA) injection Normal Saline: Single intra-articular injection	Single intra-articular (IA) injection FX006: Single intra-articular injection	Single intra-articular (IA) injection Normal Saline: Single intra-articular injection
Measure Participants	7	3	4	2
Mean (Standard Deviation) [score on a scale]	-32.00 (21.385)	-9.33 (26.633)	-52.00 (49.585)	-40.00 (5.657)

4. Secondary Outcome

Title	Change From Baseline in the SPADI Disability Subscale at Week 12
Description	Shoulder Pain and Disability Index (SPADI) Disability scale is measured using 8 11-point NRS questions where 0 indicates "no difficulty" and 10 indicates "so difficult it requires help." The Pain and Disability Subscales are presented as a percentage of the total possible score. The Total SPADI score ranges from 0 (best) to 100 (worst) is computed by taking the means of the Pain and Disability Subscale scores.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

All patients who received a dose of study drug assigned to the FX006 32 mg and the Placebo arm were included in the analysis.

Arm/Group Title	FX006 32mg in Glenohumeral OA Population	Normal Saline in Glenohumeral OA Population	FX006 32mg in Adhesive Capsulitis Population	Normal Saline in Adhesive Capsulitis Population
Arm/Group Description	Single intra-articular (IA) injection FX006: Single intra-articular injection	Single intra-articular (IA) injection Normal Saline: Single intra-articular injection	Single intra-articular (IA) injection FX006: Single intra-articular injection	Single intra-articular (IA) injection Normal Saline: Single intra-articular injection
Measure Participants	6	3	4	2
Mean (Standard Deviation) [score on a scale]	-32.29 (9.435)	-10.42 (17.559)	-50.94 (31.842)	-50.00 (21.213)

5. Secondary Outcome

Title	Patient Global Impression of Change (PGIC) Score at Week 12
Description	PGIC is measured using a 7-point NRS where 1 indicates "very much improved" and 7 indicates "very much worse."
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

All patients who received a dose of study drug assigned to the FX006 32 mg and the Placebo arm were included in the analysis.

Arm/Group Title	FX006 32mg in Glenohumeral OA Population	Normal Saline in Glenohumeral OA Population	FX006 32mg in Adhesive Capsulitis Population	Normal Saline in Adhesive Capsulitis Population
Arm/Group Description	Single intra-articular (IA) injection FX006: Single intra-articular injection	Single intra-articular (IA) injection Normal Saline: Single intra-articular injection	Single intra-articular (IA) injection FX006: Single intra-articular injection	Single intra-articular (IA) injection Normal Saline: Single intra-articular injection
Measure Participants	6	3	4	2
Mean (Standard Deviation) [score on a scale]	2.7 (1.51)	3.3 (1.15)	1.5 (0.58)	2.5 (0.71)

6. Secondary Outcome

Title	Change From Baseline in the Range of Motion (ROM) of Active External Rotation at Week 12
Description	Measured using a goniometer which is a device that measures ROM joint angles
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

All patients who received a dose of study drug assigned to the FX006 32 mg and the Placebo arm were included in the analysis.

Arm/Group Title	FX006 32mg in Glenohumeral OA Population	Normal Saline in Glenohumeral OA Population	FX006 32mg in Adhesive Capsulitis Population	Normal Saline in Adhesive Capsulitis Population
Arm/Group Description	Single intra-articular (IA) injection FX006: Single intra-articular injection	Single intra-articular (IA) injection Normal Saline: Single intra-articular injection	Single intra-articular (IA) injection FX006: Single intra-articular injection	Single intra-articular (IA) injection Normal Saline: Single intra-articular injection
Measure Participants	5	3	4	1
Mean (Standard Deviation) [Degrees]	-4.76 (13.068)	7.87 (26.307)	68.70 (81.850)	-4.60 (NA)

Adverse Events

Time Frame	Adverse events were collected from the time of informed consent until the end of patient participation in the study up to 24 weeks.
Arm/Group Title	FX006 32mg in Glenohumeral OA Population		Normal Saline in Glenohumeral OA Population		FX006 32mg in Adhesive Capsulitis Population		Normal Saline in Adhesive Capsulitis Population
Arm/Group Description	Single intra-articular (IA) injection FX006: Single intra-articular injection		Single intra-articular (IA) injection Normal Saline: Single intra-articular injection		Single intra-articular (IA) injection FX006: Single intra-articular injection		Single intra-articular (IA) injection Normal Saline: Single intra-articular injection
All Cause Mortality
	FX006 32mg in Glenohumeral OA Population		Normal Saline in Glenohumeral OA Population		FX006 32mg in Adhesive Capsulitis Population		Normal Saline in Adhesive Capsulitis Population
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)
Serious Adverse Events
	FX006 32mg in Glenohumeral OA Population		Normal Saline in Glenohumeral OA Population		FX006 32mg in Adhesive Capsulitis Population		Normal Saline in Adhesive Capsulitis Population
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/3 (0%)		0/5 (0%)		0/4 (0%)
Other (Not Including Serious) Adverse Events
	FX006 32mg in Glenohumeral OA Population		Normal Saline in Glenohumeral OA Population		FX006 32mg in Adhesive Capsulitis Population		Normal Saline in Adhesive Capsulitis Population
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/7 (14.3%)		0/3 (0%)		2/5 (40%)		0/4 (0%)
Injury, poisoning and procedural complications
Ligament Sprain	0/7 (0%)	0	0/3 (0%)	0	1/5 (20%)	1	0/4 (0%)	0
Musculoskeletal and connective tissue disorders
Pain in Extremity	0/7 (0%)	0	0/3 (0%)	0	1/5 (20%)	1	0/4 (0%)	0
Nervous system disorders
Migraine	1/7 (14.3%)	1	0/3 (0%)	0	0/5 (0%)	0	0/4 (0%)	0
Respiratory, thoracic and mediastinal disorders
Bronchospasm	0/7 (0%)	0	0/3 (0%)	0	1/5 (20%)	1	0/4 (0%)	0
Chronic obstructive pulmonary disease	0/7 (0%)	0	0/3 (0%)	0	1/5 (20%)	1	0/4 (0%)	0
Skin and subcutaneous tissue disorders
Dermatitis allergic	0/7 (0%)	0	0/3 (0%)	0	1/5 (20%)	1	0/4 (0%)	0
Vascular disorders
Haematoma	0/7 (0%)	0	0/3 (0%)	0	1/5 (20%)	1	0/4 (0%)	0

Limitations/Caveats

This study was terminated early by the Sponsor due to the COVID-19 pandemic. Summary statistics were calculated for available data, but given that only approximately 8% of the planned study population had enrolled and there no conclusions can be drawn from this study.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.