Trial Outcomes & Findings for A Multiple Injection Study Evaluating Safety and Efficacy of Ampion in Osteoarthritis (NCT NCT02242435)

Last Updated: 2022-09-15

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

342 participants

Primary outcome timeframe

Scored at Baseline and 20 Weeks

Results posted on

2022-09-15

Participant Flow

Recruitment of subjects occurred in medical clinics during the months of September, October, and November 2014.

No pharmacological or non-pharmacological treatment targeting osteoarthritis (OA) started or changed during the 4 weeks prior to randomization or likely to be changed during the duration of the study.

Participant milestones

Participant milestones
Measure	Ampion 4 mL 4 mL intra-articular injection of Ampion Ampion \<5 kilodalton (kDa) ultrafiltrate of 5% human serum albumin: 4 mL intra-articular injection of Ampion	Placebo 4 mL 4 mL placebo intra-articular injection Placebo: Saline
Overall Study STARTED	172	170
Overall Study COMPLETED	152	154
Overall Study NOT COMPLETED	20	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Ampion 4 mL 4 mL intra-articular injection of Ampion Ampion \<5 kilodalton (kDa) ultrafiltrate of 5% human serum albumin: 4 mL intra-articular injection of Ampion	Placebo 4 mL 4 mL placebo intra-articular injection Placebo: Saline
Overall Study Lost to Follow-up	3	4
Overall Study Adverse Event	3	2
Overall Study Withdrawal by Subject	13	8
Overall Study Death	0	1
Overall Study Protocol Violation	1	0
Overall Study Physician Decision	0	1

Baseline Characteristics

A Multiple Injection Study Evaluating Safety and Efficacy of Ampion in Osteoarthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ampion 4 mL n=172 Participants 4 mL intra-articular injection of Ampion Ampion \<5 kDa ultrafiltrate of 5% human serum albumin	Placebo 4 mL n=170 Participants 4 mL placebo intra-articular injection Placebo: Saline	Total n=342 Participants Total of all reporting groups
Age, Continuous	63.3 years STANDARD_DEVIATION 9.1 • n=5 Participants	63.2 years STANDARD_DEVIATION 9.5 • n=7 Participants	63.2 years STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male Female	93 Participants n=5 Participants	105 Participants n=7 Participants	198 Participants n=5 Participants
Sex: Female, Male Male	79 Participants n=5 Participants	65 Participants n=7 Participants	144 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	161 Participants n=5 Participants	158 Participants n=7 Participants	319 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	22 Participants n=5 Participants	36 Participants n=7 Participants	58 Participants n=5 Participants
Race (NIH/OMB) White	146 Participants n=5 Participants	130 Participants n=7 Participants	276 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 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	172 participants n=5 Participants	170 participants n=7 Participants	342 participants n=5 Participants
Weight (kg)	96.2 kg STANDARD_DEVIATION 23.8 • n=5 Participants	96.4 kg STANDARD_DEVIATION 22.5 • n=7 Participants	96.3 kg STANDARD_DEVIATION 23.2 • n=5 Participants
BMI (kg/m^2)	34.3 kg/m^2 STANDARD_DEVIATION 7.5 • n=5 Participants	34.9 kg/m^2 STANDARD_DEVIATION 8.0 • n=7 Participants	34.6 kg/m^2 STANDARD_DEVIATION 7.8 • n=5 Participants
Kellgren-Lawrence (KL) Grade Kellgren-Lawrence Grade III	50 Participants n=5 Participants	64 Participants n=7 Participants	114 Participants n=5 Participants
Kellgren-Lawrence (KL) Grade Kellgren-Lawrence Grade IV	122 Participants n=5 Participants	106 Participants n=7 Participants	228 Participants n=5 Participants
WOMAC Pain	2.51 score on a scale STANDARD_DEVIATION 0.57 • n=5 Participants	2.57 score on a scale STANDARD_DEVIATION 0.61 • n=7 Participants	2.54 score on a scale STANDARD_DEVIATION 0.59 • n=5 Participants
WOMAC Function	2.51 score on a scale STANDARD_DEVIATION 0.63 • n=5 Participants	2.59 score on a scale STANDARD_DEVIATION 0.61 • n=7 Participants	2.55 score on a scale STANDARD_DEVIATION 0.62 • n=5 Participants

PRIMARY outcome

Timeframe: Scored at Baseline and 20 Weeks

Population: Intent to Treat (ITT)

Outcome measures

Outcome measures
Measure	Ampion 4 mL Injection n=172 Participants 4 mL intra-articular injection of Ampion Ampion: \<5 kDa ultrafiltrate of 5% human serum albumin	Placebo 4 mL Injection n=170 Participants 4 mL placebo intra-articular injection Placebo: Saline
Change in Knee Pain	-0.96 score on a scale Interval -1.09 to -0.82	-1.10 score on a scale Interval -1.24 to -0.95

SECONDARY outcome

Timeframe: Scored at Baseline and 20 Weeks

Population: Intent to Treat (ITT)

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	Ampion 4 mL Injection n=172 Participants 4 mL intra-articular injection of Ampion Ampion: \<5 kDa ultrafiltrate of 5% human serum albumin	Placebo 4 mL Injection n=170 Participants 4 mL placebo intra-articular injection Placebo: Saline
Change in Knee Function	-0.94 score on a scale Interval -1.08 to -0.81	-1.08 score on a scale Interval -1.22 to -0.94

Adverse Events

Ampion 4 mL

Serious events: 4 serious events

Other events: 107 other events

Deaths: 0 deaths

Placebo 4 mL

Serious events: 11 serious events

Other events: 125 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Ampion 4 mL n=172 participants at risk 4 mL intra-articular injection of Ampion Ampion \<5 kDa ultrafiltrate of 5% human serum albumin: 4 mL intra-articular injection of Ampion	Placebo 4 mL n=170 participants at risk 4 mL placebo intra-articular injection Placebo: Saline
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma Cell Myeloma	0.00% 0/172 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.	1.2% 2/170 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary Gland Cancer	0.00% 0/172 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.	0.59% 1/170 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.
Injury, poisoning and procedural complications Incisional Hernia	0.58% 1/172 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.	0.00% 0/170 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.
Injury, poisoning and procedural complications Injury	0.00% 0/172 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.	0.59% 1/170 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.
Injury, poisoning and procedural complications Joint Injury	0.00% 0/172 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.	0.59% 1/170 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.
Infections and infestations Abcess Limb	0.00% 0/172 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.	0.59% 1/170 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.
Infections and infestations Gastroenteritis	0.00% 0/172 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.	0.59% 1/170 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.
Infections and infestations Influenza	0.00% 0/172 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.	0.59% 1/170 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.
Nervous system disorders Transient Ischaemic Attack	1.2% 2/172 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.	0.00% 0/170 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.
Cardiac disorders Angina Unstable	0.00% 0/172 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.	0.59% 1/170 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.
Cardiac disorders Atrial Fibrillation	0.58% 1/172 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.	0.00% 0/170 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/172 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.	0.59% 1/170 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/172 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.	0.59% 1/170 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.
Metabolism and nutrition disorders Dehydration	0.00% 0/172 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.	0.59% 1/170 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.

Other adverse events

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

Restriction type: LTE60

Measure	Ampion 4 mL n=172 participants at risk 4 mL intra-articular injection of Ampion Ampion \<5 kDa ultrafiltrate of 5% human serum albumin: 4 mL intra-articular injection of Ampion	Placebo 4 mL n=170 participants at risk 4 mL placebo intra-articular injection Placebo: Saline
Gastrointestinal disorders Nausea	0.00% 0/172 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.	2.4% 4/170 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.
General disorders Injection Site Bruising	1.7% 3/172 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.	1.8% 3/170 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.
General disorders Injection Site Pain	6.4% 11/172 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.	5.9% 10/170 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.
General disorders Injection Site Swelling	1.2% 2/172 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.	1.8% 3/170 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.
General disorders Oedema Peripheral	0.58% 1/172 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.	2.4% 4/170 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.
General disorders Pain	1.7% 3/172 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.	0.00% 0/170 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.
Infections and infestations Bronchitis	2.9% 5/172 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.	3.5% 6/170 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.
Infections and infestations Gastroenteritis	1.7% 3/172 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.	2.4% 4/170 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.
Infections and infestations Influenza	0.58% 1/172 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.	1.8% 3/170 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.
Infections and infestations Nasopharyngitis	2.9% 5/172 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.	0.59% 1/170 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.
Infections and infestations Respiratory Tract Infection Viral	1.7% 3/172 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.	0.00% 0/170 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.
Infections and infestations Sinusitis	2.9% 5/172 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.	2.4% 4/170 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.
Infections and infestations Upper Respiratory Tract Infection	5.8% 10/172 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.	5.9% 10/170 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.
Injury, poisoning and procedural complications Contusion	4.1% 7/172 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.	2.4% 4/170 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.
Injury, poisoning and procedural complications Fall	1.2% 2/172 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.	2.4% 4/170 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.
Injury, poisoning and procedural complications Joint Injury	2.3% 4/172 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.	0.59% 1/170 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.
Musculoskeletal and connective tissue disorders Arthralgia	11.0% 19/172 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.	12.4% 21/170 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/172 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.	2.4% 4/170 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.
Musculoskeletal and connective tissue disorders Joint Stiffness	2.3% 4/172 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.	2.4% 4/170 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.
Musculoskeletal and connective tissue disorders Joint Swelling	1.7% 3/172 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.	3.5% 6/170 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.
Musculoskeletal and connective tissue disorders Pain in Extremity	1.7% 3/172 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.	2.4% 4/170 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.
Musculoskeletal and connective tissue disorders Plantar Fasciitis	0.58% 1/172 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.	1.8% 3/170 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.
Nervous system disorders Headache	2.9% 5/172 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.	1.8% 3/170 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.
Respiratory, thoracic and mediastinal disorders Cough	1.7% 3/172 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.	1.2% 2/170 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.
Vascular disorders Hypertension	1.7% 3/172 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.	4.7% 8/170 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/172 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.	1.8% 3/170 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/172 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.	1.8% 3/170 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.
Skin and subcutaneous tissue disorders Rash	0.58% 1/172 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.	1.8% 3/170 • 24 Weeks Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.