Trial Outcomes & Findings for A Study to Evaluate the Efficacy & Safety of an Intra-Articular Ampion Injection for Pain of Osteoarthritis of the Knee (NCT NCT02556710)

Last Updated: 2022-08-09

Results Overview

Mean Change in WOMAC A Pain (Western Ontario and McMaster Universities Arthritis Index) score from Baseline to 12 weeks. 5-point Likert scale (0=none to 4=extreme). A negative difference constitutes a decrease in pain with a greater negative value indicating a greater reduction in pain.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

480 participants

Primary outcome timeframe

Scored at Baseline and 12 weeks

Results posted on

2022-08-09

Participant Flow

Subjects will be recruited from the population being seen by Investigators at the clinical sites participating in the study. In addition, notifications about the opportunity for subjects to participate in a clinical trial will be sent to referring physicians.

Ability to discontinue NSAID use at Screening visit and/or 72 hours prior to the Baseline visit and for the duration of the clinical study. No analgesia (including acetaminophen \[paracetamol\]) taken 24 hours prior to an efficacy measure.

Participant milestones

Participant milestones
Measure	4 mL AMPION™ AMPION™: 4 mL Ampion Injection	4 mL Saline Placebo Saline: 4 mL Saline Injection
Overall Study STARTED	237	243
Overall Study COMPLETED	226	237
Overall Study NOT COMPLETED	11	6

Reasons for withdrawal

Reasons for withdrawal
Measure	4 mL AMPION™ AMPION™: 4 mL Ampion Injection	4 mL Saline Placebo Saline: 4 mL Saline Injection
Overall Study Surgical treatment	3	0
Overall Study Required proscribed pain medication	2	1
Overall Study Lack of Efficacy	1	0
Overall Study Worsening osteoarthritis	1	0
Overall Study Moved out of state	1	0
Overall Study Missing reason	3	1
Overall Study Pain as lack of efficacy	0	4

Baseline Characteristics

A Study to Evaluate the Efficacy & Safety of an Intra-Articular Ampion Injection for Pain of Osteoarthritis of the Knee

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	4 mL AMPION™ n=237 Participants AMPION™: 4 mL Ampion Injection	4 mL Saline Placebo n=243 Participants Saline: 4 mL Saline Injection	Total n=480 Participants Total of all reporting groups
Age, Continuous	61.6 years STANDARD_DEVIATION 9.05 • n=5 Participants	60.8 years STANDARD_DEVIATION 8.84 • n=7 Participants	61.2 years STANDARD_DEVIATION 8.95 • n=5 Participants
Sex: Female, Male Female	159 Participants n=5 Participants	152 Participants n=7 Participants	311 Participants n=5 Participants
Sex: Female, Male Male	78 Participants n=5 Participants	91 Participants n=7 Participants	169 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	17 Participants n=5 Participants	15 Participants n=7 Participants	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	219 Participants n=5 Participants	228 Participants n=7 Participants	447 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	51 Participants n=5 Participants	42 Participants n=7 Participants	93 Participants n=5 Participants
Race (NIH/OMB) White	180 Participants n=5 Participants	197 Participants n=7 Participants	377 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	237 participants n=5 Participants	243 participants n=7 Participants	480 participants n=5 Participants
Weight (kg)	91.49 kg STANDARD_DEVIATION 22.38 • n=5 Participants	95.19 kg STANDARD_DEVIATION 22.32 • n=7 Participants	93.36 kg STANDARD_DEVIATION 22.41 • n=5 Participants
BMI (kg/m^2)	32.94 kg/m^2 STANDARD_DEVIATION 6.98 • n=5 Participants	33.91 kg/m^2 STANDARD_DEVIATION 7.58 • n=7 Participants	33.43 kg/m^2 STANDARD_DEVIATION 7.30 • n=5 Participants
Kellgren Lawrence Grade Kellgren-Lawrence Grade II	50 Participants n=5 Participants	51 Participants n=7 Participants	101 Participants n=5 Participants
Kellgren Lawrence Grade Kellgren-Lawrence Grade III	122 Participants n=5 Participants	125 Participants n=7 Participants	247 Participants n=5 Participants
Kellgren Lawrence Grade Kellgren-Lawrence Grade IV	65 Participants n=5 Participants	67 Participants n=7 Participants	132 Participants n=5 Participants
WOMAC Pain	2.37 score on a scale STANDARD_DEVIATION 0.56 • n=5 Participants	2.33 score on a scale STANDARD_DEVIATION 0.53 • n=7 Participants	2.35 score on a scale STANDARD_DEVIATION 0.54 • n=5 Participants
WOMAC Function	2.37 score on a scale STANDARD_DEVIATION 0.64 • n=5 Participants	2.34 score on a scale STANDARD_DEVIATION 0.60 • n=7 Participants	2.36 score on a scale STANDARD_DEVIATION 0.62 • n=5 Participants

PRIMARY outcome

Timeframe: Scored at Baseline and 12 weeks

Population: Intent to Treat (ITT)

Outcome measures

Outcome measures
Measure	4 mL AMPION™ n=237 Participants AMPION™: 4 mL Ampion Injection	4 mL Saline Placebo n=243 Participants Saline: 4 mL Saline Injection
Change in Knee Pain	-0.91 score on a scale Interval -1.03 to -0.8	-0.89 score on a scale Interval -1.01 to -0.77

SECONDARY outcome

Timeframe: Scored at Baseline and 12 Weeks

Population: Per Protocol (PP)

Mean change in WOMAC C function score (Western Ontario and McMaster Universities Arthritis Index) from Baseline to 12 weeks. 5-point Likert scale indicating limitation of function (0=none to 4=extreme). A greater negative value indicates a improvement in function.

Outcome measures

Outcome measures
Measure	4 mL AMPION™ n=213 Participants AMPION™: 4 mL Ampion Injection	4 mL Saline Placebo n=222 Participants Saline: 4 mL Saline Injection
Change in Knee Function	-1.04 score on a scale Interval -1.17 to -0.92	-0.97 score on a scale Interval -1.1 to -0.85

POST_HOC outcome

Timeframe: Scored at Baseline and 12 weeks

Population: KL Grade IV Subset of Intent to Treat (ITT)

Outcome measures

Outcome measures
Measure	4 mL AMPION™ n=65 Participants AMPION™: 4 mL Ampion Injection	4 mL Saline Placebo n=67 Participants Saline: 4 mL Saline Injection
Change in Knee Pain of Kellgren-Lawrence Grade IV Subset	-0.81 score on a scale Interval -1.02 to -0.61	-0.62 score on a scale Interval -0.85 to -0.4

Adverse Events

4 mL AMPION™

Serious events: 2 serious events

Other events: 47 other events

Deaths: 0 deaths

4 mL Saline Placebo

Serious events: 4 serious events

Other events: 44 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	4 mL AMPION™ n=236 participants at risk AMPION™: 4 mL Ampion Injection	4 mL Saline Placebo n=243 participants at risk Saline: 4 mL Saline Injection
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.00% 0/236 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.	0.41% 1/243 • Number of events 1 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/236 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.	0.41% 1/243 • Number of events 1 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.
Nervous system disorders Cerebrovascular Accident	0.00% 0/236 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.	0.41% 1/243 • Number of events 1 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.
Nervous system disorders Migraine	0.00% 0/236 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.	0.41% 1/243 • Number of events 1 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Melanoma In Situ	0.42% 1/236 • Number of events 1 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.	0.00% 0/243 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.
Hepatobiliary disorders Cholelithiasis	0.42% 1/236 • Number of events 1 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.	0.00% 0/243 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.
Gastrointestinal disorders Intussusception	0.42% 1/236 • Number of events 1 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.	0.00% 0/243 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.

Other adverse events

Other adverse events
Measure	4 mL AMPION™ n=236 participants at risk AMPION™: 4 mL Ampion Injection	4 mL Saline Placebo n=243 participants at risk Saline: 4 mL Saline Injection
Infections and infestations Nasopharyngitis	4.2% 10/236 • Number of events 10 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.	4.1% 10/243 • Number of events 10 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.
Musculoskeletal and connective tissue disorders Arthralgia	4.7% 11/236 • Number of events 11 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.	3.3% 8/243 • Number of events 8 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.
Infections and infestations Upper Respiratory Tract Infection	2.5% 6/236 • Number of events 6 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.	5.3% 13/243 • Number of events 13 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.
Infections and infestations Sinusitis	2.5% 6/236 • Number of events 6 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.	1.6% 4/243 • Number of events 4 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.
Nervous system disorders Headache	2.1% 5/236 • Number of events 5 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.	0.82% 2/243 • Number of events 2 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.
Musculoskeletal and connective tissue disorders Back Pain	1.7% 4/236 • Number of events 4 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.	0.82% 2/243 • Number of events 2 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.
Vascular disorders Hypertension	0.42% 1/236 • Number of events 1 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.	1.6% 4/243 • Number of events 4 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.
Musculoskeletal and connective tissue disorders Joint Swelling	1.7% 4/236 • Number of events 4 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.	0.41% 1/243 • Number of events 1 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.

Additional Information

Dr. Howard Levy / Chief Medical Officer

Ampio Pharmaceuticals

Phone: 7204376500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place