Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of FX006 in Patients With Glenohumeral Osteoarthritis or Shoulder Adhesive Capsulitis (NCT NCT04160091)

NCT ID: NCT04160091

Last Updated: 2024-01-24

Results Overview

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."

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 19 participants
• Primary outcome timeframe: Baseline to 8 weeks
• Results posted on: 2024-01-24

Participant Flow

Participant milestones

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

Reasons for withdrawal

Measure	FX006 32mg in Glenohumeral OA Population Single intra-articular (IA) injection FX006: Single intra-articular injection	Normal Saline in Glenohumeral OA Population Single intra-articular (IA) injection Normal Saline: Single intra-articular injection	FX006 32mg in Adhesive Capsulitis Population Single intra-articular (IA) injection FX006: Single intra-articular injection	Normal Saline in Adhesive Capsulitis Population Single intra-articular (IA) injection Normal Saline: Single intra-articular injection
Overall Study Terminated by Sponsor	7	3	5	2
Overall Study Noncompliance	0	0	0	1
Overall Study Withdrawal by Subject	0	0	0	1

Baseline Characteristics

The two populations were analyzed separately

Baseline characteristics by cohort

Measure	FX006 32mg in Glenohumeral OA Population n=7 Participants Single intra-articular (IA) injection FX006: Single intra-articular injection	Normal Saline in Glenohumeral OA Population n=3 Participants Single intra-articular (IA) injection Normal Saline: Single intra-articular injection	FX006 32mg in Adhesive Capsulitis Population n=5 Participants Single intra-articular (IA) injection FX006: Single intra-articular injection	Normal Saline in Adhesive Capsulitis Population n=4 Participants Single intra-articular (IA) injection Normal Saline: Single intra-articular injection	Total n=19 Participants Total of all reporting groups
Age, Continuous OA Population	61.7 years STANDARD_DEVIATION 13.07 • n=7 Participants • The two populations were analyzed separately	60.0 years STANDARD_DEVIATION 2.65 • n=3 Participants • The two populations were analyzed separately	—	—	61.2 years STANDARD_DEVIATION 10.78 • n=10 Participants • The two populations were analyzed separately
Age, Continuous Adhesive Capsulitis Population	—	—	56.2 years STANDARD_DEVIATION 12.64 • n=5 Participants • The two populations were analyzed separately	58.5 years STANDARD_DEVIATION 4.80 • n=4 Participants • The two populations were analyzed separately	57.2 years STANDARD_DEVIATION 9.48 • n=9 Participants • The two populations were analyzed separately
Sex: Female, Male OA Population · Female	1 Participants n=7 Participants • The two populations were analyzed separately	1 Participants n=3 Participants • The two populations were analyzed separately	—	—	2 Participants n=10 Participants • The two populations were analyzed separately
Sex: Female, Male OA Population · Male	6 Participants n=7 Participants • The two populations were analyzed separately	2 Participants n=3 Participants • The two populations were analyzed separately	—	—	8 Participants n=10 Participants • The two populations were analyzed separately
Sex: Female, Male Adhesive Capsulitis Population · Female	—	—	4 Participants n=5 Participants • The two populations were analyzed separately	3 Participants n=4 Participants • The two populations were analyzed separately	7 Participants n=9 Participants • The two populations were analyzed separately
Sex: Female, Male Adhesive Capsulitis Population · Male	—	—	1 Participants n=5 Participants • The two populations were analyzed separately	1 Participants n=4 Participants • The two populations were analyzed separately	2 Participants n=9 Participants • The two populations were analyzed separately
Ethnicity (NIH/OMB) OA Population · Hispanic or Latino	1 Participants n=7 Participants • The two populations were analyzed separately	0 Participants n=3 Participants • The two populations were analyzed separately	—	—	1 Participants n=10 Participants • The two populations were analyzed separately
Ethnicity (NIH/OMB) OA Population · Not Hispanic or Latino	6 Participants n=7 Participants • The two populations were analyzed separately	3 Participants n=3 Participants • The two populations were analyzed separately	—	—	9 Participants n=10 Participants • The two populations were analyzed separately
Ethnicity (NIH/OMB) OA Population · Unknown or Not Reported	0 Participants n=7 Participants • The two populations were analyzed separately	0 Participants n=3 Participants • The two populations were analyzed separately	—	—	0 Participants n=10 Participants • The two populations were analyzed separately
Ethnicity (NIH/OMB) Adhesive Capsulitis Population · Hispanic or Latino	—	—	1 Participants n=5 Participants • The two populations were analyzed separately	0 Participants n=4 Participants • The two populations were analyzed separately	1 Participants n=9 Participants • The two populations were analyzed separately
Ethnicity (NIH/OMB) Adhesive Capsulitis Population · Not Hispanic or Latino	—	—	4 Participants n=5 Participants • The two populations were analyzed separately	4 Participants n=4 Participants • The two populations were analyzed separately	8 Participants n=9 Participants • The two populations were analyzed separately
Ethnicity (NIH/OMB) Adhesive Capsulitis Population · Unknown or Not Reported	—	—	0 Participants n=5 Participants • The two populations were analyzed separately	0 Participants n=4 Participants • The two populations were analyzed separately	0 Participants n=9 Participants • The two populations were analyzed separately
Race (NIH/OMB) OA Population · American Indian or Alaska Native	0 Participants n=7 Participants • The two populations were analyzed separately	0 Participants n=3 Participants • The two populations were analyzed separately	—	—	0 Participants n=10 Participants • The two populations were analyzed separately
Race (NIH/OMB) OA Population · Asian	0 Participants n=7 Participants • The two populations were analyzed separately	0 Participants n=3 Participants • The two populations were analyzed separately	—	—	0 Participants n=10 Participants • The two populations were analyzed separately
Race (NIH/OMB) OA Population · Native Hawaiian or Other Pacific Islander	0 Participants n=7 Participants • The two populations were analyzed separately	0 Participants n=3 Participants • The two populations were analyzed separately	—	—	0 Participants n=10 Participants • The two populations were analyzed separately
Race (NIH/OMB) OA Population · Black or African American	1 Participants n=7 Participants • The two populations were analyzed separately	1 Participants n=3 Participants • The two populations were analyzed separately	—	—	2 Participants n=10 Participants • The two populations were analyzed separately
Race (NIH/OMB) OA Population · White	6 Participants n=7 Participants • The two populations were analyzed separately	1 Participants n=3 Participants • The two populations were analyzed separately	—	—	7 Participants n=10 Participants • The two populations were analyzed separately
Race (NIH/OMB) OA Population · More than one race	0 Participants n=7 Participants • The two populations were analyzed separately	0 Participants n=3 Participants • The two populations were analyzed separately	—	—	0 Participants n=10 Participants • The two populations were analyzed separately
Race (NIH/OMB) OA Population · Unknown or Not Reported	0 Participants n=7 Participants • The two populations were analyzed separately	1 Participants n=3 Participants • The two populations were analyzed separately	—	—	1 Participants n=10 Participants • The two populations were analyzed separately
Race (NIH/OMB) Adhesive Capsulitis Population · American Indian or Alaska Native	—	—	0 Participants n=5 Participants • The two populations were analyzed separately	0 Participants n=4 Participants • The two populations were analyzed separately	0 Participants n=9 Participants • The two populations were analyzed separately
Race (NIH/OMB) Adhesive Capsulitis Population · Asian	—	—	0 Participants n=5 Participants • The two populations were analyzed separately	0 Participants n=4 Participants • The two populations were analyzed separately	0 Participants n=9 Participants • The two populations were analyzed separately
Race (NIH/OMB) Adhesive Capsulitis Population · Native Hawaiian or Other Pacific Islander	—	—	0 Participants n=5 Participants • The two populations were analyzed separately	0 Participants n=4 Participants • The two populations were analyzed separately	0 Participants n=9 Participants • The two populations were analyzed separately
Race (NIH/OMB) Adhesive Capsulitis Population · Black or African American	—	—	1 Participants n=5 Participants • The two populations were analyzed separately	0 Participants n=4 Participants • The two populations were analyzed separately	1 Participants n=9 Participants • The two populations were analyzed separately
Race (NIH/OMB) Adhesive Capsulitis Population · White	—	—	4 Participants n=5 Participants • The two populations were analyzed separately	4 Participants n=4 Participants • The two populations were analyzed separately	8 Participants n=9 Participants • The two populations were analyzed separately
Race (NIH/OMB) Adhesive Capsulitis Population · More than one race	—	—	0 Participants n=5 Participants • The two populations were analyzed separately	0 Participants n=4 Participants • The two populations were analyzed separately	0 Participants n=9 Participants • The two populations were analyzed separately
Race (NIH/OMB) Adhesive Capsulitis Population · Unknown or Not Reported	—	—	0 Participants n=5 Participants • The two populations were analyzed separately	0 Participants n=4 Participants • The two populations were analyzed separately	0 Participants n=9 Participants • The two populations were analyzed separately
Region of Enrollment United States	7 participants n=7 Participants	3 participants n=3 Participants	5 participants n=5 Participants	4 participants n=4 Participants	19 participants n=19 Participants
Body Mass Index (BMI) OA Population	28.95 kg/m^2 STANDARD_DEVIATION 2.473 • n=7 Participants • The two populations were analyzed separately	30.61 kg/m^2 STANDARD_DEVIATION 3.744 • n=3 Participants • The two populations were analyzed separately	—	—	29.45 kg/m^2 STANDARD_DEVIATION 2.799 • n=10 Participants • The two populations were analyzed separately
Body Mass Index (BMI) Adhesive Capsulitis Population	—	—	33.03 kg/m^2 STANDARD_DEVIATION 4.425 • n=5 Participants • The two populations were analyzed separately	27.99 kg/m^2 STANDARD_DEVIATION 6.752 • n=4 Participants • The two populations were analyzed separately	30.79 kg/m^2 STANDARD_DEVIATION 5.826 • n=9 Participants • The two populations were analyzed separately

PRIMARY outcome

Timeframe: Baseline to 8 weeks

Population: 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

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."

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 12 weeks

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

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."

Outcome measures

Measure	FX006 32mg in Glenohumeral OA Population n=7 Participants Single intra-articular (IA) injection FX006: Single intra-articular injection	Normal Saline in Glenohumeral OA Population n=2 Participants Single intra-articular (IA) injection Normal Saline: Single intra-articular injection	FX006 32mg in Adhesive Capsulitis Population n=5 Participants Single intra-articular (IA) injection FX006: Single intra-articular injection	Normal Saline in Adhesive Capsulitis Population n=2 Participants Single intra-articular (IA) injection Normal Saline: Single intra-articular injection
Change From Baseline in the Weekly Mean of the Average Daily Shoulder Pain With Movement Score	-3.54 score on a scale Standard Deviation 2.477	-0.88 score on a scale Standard Deviation 1.237	-4.05 score on a scale Standard Deviation 2.648	-1.58 score on a scale Standard Deviation 2.003

SECONDARY outcome

Timeframe: Baseline to 12 weeks

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

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.

Outcome measures

Measure	FX006 32mg in Glenohumeral OA Population n=7 Participants Single intra-articular (IA) injection FX006: Single intra-articular injection	Normal Saline in Glenohumeral OA Population n=3 Participants Single intra-articular (IA) injection Normal Saline: Single intra-articular injection	FX006 32mg in Adhesive Capsulitis Population n=4 Participants Single intra-articular (IA) injection FX006: Single intra-articular injection	Normal Saline in Adhesive Capsulitis Population n=2 Participants Single intra-articular (IA) injection Normal Saline: Single intra-articular injection
Change From Baseline in the SPADI Pain Subscale at Week 12	-32.00 score on a scale Standard Deviation 21.385	-9.33 score on a scale Standard Deviation 26.633	-52.00 score on a scale Standard Deviation 49.585	-40.00 score on a scale Standard Deviation 5.657

SECONDARY outcome

Timeframe: Baseline to 12 weeks

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

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.

Outcome measures

Measure	FX006 32mg in Glenohumeral OA Population n=6 Participants Single intra-articular (IA) injection FX006: Single intra-articular injection	Normal Saline in Glenohumeral OA Population n=3 Participants Single intra-articular (IA) injection Normal Saline: Single intra-articular injection	FX006 32mg in Adhesive Capsulitis Population n=4 Participants Single intra-articular (IA) injection FX006: Single intra-articular injection	Normal Saline in Adhesive Capsulitis Population n=2 Participants Single intra-articular (IA) injection Normal Saline: Single intra-articular injection
Change From Baseline in the SPADI Disability Subscale at Week 12	-32.29 score on a scale Standard Deviation 9.435	-10.42 score on a scale Standard Deviation 17.559	-50.94 score on a scale Standard Deviation 31.842	-50.00 score on a scale Standard Deviation 21.213

SECONDARY outcome

Timeframe: Baseline to 12 weeks

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

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

Outcome measures

Measure	FX006 32mg in Glenohumeral OA Population n=6 Participants Single intra-articular (IA) injection FX006: Single intra-articular injection	Normal Saline in Glenohumeral OA Population n=3 Participants Single intra-articular (IA) injection Normal Saline: Single intra-articular injection	FX006 32mg in Adhesive Capsulitis Population n=4 Participants Single intra-articular (IA) injection FX006: Single intra-articular injection	Normal Saline in Adhesive Capsulitis Population n=2 Participants Single intra-articular (IA) injection Normal Saline: Single intra-articular injection
Patient Global Impression of Change (PGIC) Score at Week 12	2.7 score on a scale Standard Deviation 1.51	3.3 score on a scale Standard Deviation 1.15	1.5 score on a scale Standard Deviation 0.58	2.5 score on a scale Standard Deviation 0.71

SECONDARY outcome

Timeframe: Baseline to 12 weeks

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

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

Outcome measures

Measure	FX006 32mg in Glenohumeral OA Population n=5 Participants Single intra-articular (IA) injection FX006: Single intra-articular injection	Normal Saline in Glenohumeral OA Population n=3 Participants Single intra-articular (IA) injection Normal Saline: Single intra-articular injection	FX006 32mg in Adhesive Capsulitis Population n=4 Participants Single intra-articular (IA) injection FX006: Single intra-articular injection	Normal Saline in Adhesive Capsulitis Population n=1 Participants Single intra-articular (IA) injection Normal Saline: Single intra-articular injection
Change From Baseline in the Range of Motion (ROM) of Active External Rotation at Week 12	-4.76 Degrees Standard Deviation 13.068	7.87 Degrees Standard Deviation 26.307	68.70 Degrees Standard Deviation 81.850	-4.60 Degrees Standard Deviation NA There was only participant analyzed.

Adverse Events

FX006 32mg in Glenohumeral OA Population

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Normal Saline in Glenohumeral OA Population

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

FX006 32mg in Adhesive Capsulitis Population

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Normal Saline in Adhesive Capsulitis Population

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	FX006 32mg in Glenohumeral OA Population n=7 participants at risk Single intra-articular (IA) injection FX006: Single intra-articular injection	Normal Saline in Glenohumeral OA Population n=3 participants at risk Single intra-articular (IA) injection Normal Saline: Single intra-articular injection	FX006 32mg in Adhesive Capsulitis Population n=5 participants at risk Single intra-articular (IA) injection FX006: Single intra-articular injection	Normal Saline in Adhesive Capsulitis Population n=4 participants at risk Single intra-articular (IA) injection Normal Saline: Single intra-articular injection
Nervous system disorders Migraine	14.3% 1/7 • Number of events 1 • Adverse events were collected from the time of informed consent until the end of patient participation in the study up to 24 weeks.	0.00% 0/3 • Adverse events were collected from the time of informed consent until the end of patient participation in the study up to 24 weeks.	0.00% 0/5 • Adverse events were collected from the time of informed consent until the end of patient participation in the study up to 24 weeks.	0.00% 0/4 • Adverse events were collected from the time of informed consent until the end of patient participation in the study up to 24 weeks.
Injury, poisoning and procedural complications Ligament Sprain	0.00% 0/7 • Adverse events were collected from the time of informed consent until the end of patient participation in the study up to 24 weeks.	0.00% 0/3 • Adverse events were collected from the time of informed consent until the end of patient participation in the study up to 24 weeks.	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of informed consent until the end of patient participation in the study up to 24 weeks.	0.00% 0/4 • Adverse events were collected from the time of informed consent until the end of patient participation in the study up to 24 weeks.
Musculoskeletal and connective tissue disorders Pain in Extremity	0.00% 0/7 • Adverse events were collected from the time of informed consent until the end of patient participation in the study up to 24 weeks.	0.00% 0/3 • Adverse events were collected from the time of informed consent until the end of patient participation in the study up to 24 weeks.	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of informed consent until the end of patient participation in the study up to 24 weeks.	0.00% 0/4 • Adverse events were collected from the time of informed consent until the end of patient participation in the study up to 24 weeks.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/7 • Adverse events were collected from the time of informed consent until the end of patient participation in the study up to 24 weeks.	0.00% 0/3 • Adverse events were collected from the time of informed consent until the end of patient participation in the study up to 24 weeks.	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of informed consent until the end of patient participation in the study up to 24 weeks.	0.00% 0/4 • Adverse events were collected from the time of informed consent until the end of patient participation in the study up to 24 weeks.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/7 • Adverse events were collected from the time of informed consent until the end of patient participation in the study up to 24 weeks.	0.00% 0/3 • Adverse events were collected from the time of informed consent until the end of patient participation in the study up to 24 weeks.	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of informed consent until the end of patient participation in the study up to 24 weeks.	0.00% 0/4 • Adverse events were collected from the time of informed consent until the end of patient participation in the study up to 24 weeks.
Vascular disorders Haematoma	0.00% 0/7 • Adverse events were collected from the time of informed consent until the end of patient participation in the study up to 24 weeks.	0.00% 0/3 • Adverse events were collected from the time of informed consent until the end of patient participation in the study up to 24 weeks.	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of informed consent until the end of patient participation in the study up to 24 weeks.	0.00% 0/4 • Adverse events were collected from the time of informed consent until the end of patient participation in the study up to 24 weeks.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/7 • Adverse events were collected from the time of informed consent until the end of patient participation in the study up to 24 weeks.	0.00% 0/3 • Adverse events were collected from the time of informed consent until the end of patient participation in the study up to 24 weeks.	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of informed consent until the end of patient participation in the study up to 24 weeks.	0.00% 0/4 • Adverse events were collected from the time of informed consent until the end of patient participation in the study up to 24 weeks.

Additional Information

David Golod, Vice President, Clinical Operations

Flexion Therapeutics, Inc.

Phone: (781) 305-7572

Email: dgolod@flexiontherapeutics.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60