Trial Outcomes & Findings for AP-003-C Study to Confirm the Efficacy of Ampion™ in Adults With Pain Due to Severe Osteoarthritis of the Knee (NCT NCT03182686)

Last Updated: 2022-08-09

Results Overview

Using the Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) criteria of WOMAC A Pain subscore, WOMAC C Function subscore, and PGA as composite endpoints. A patient in this study will be considered a responder for the purpose of efficacy analysis if the following criteria are met: (1) demonstration of ≥ 50% improvement AND a 1.0-unit change in pain OR 1.0-unit change in function OR If the patient does not meet this criterion, then the patient must demonstrate at least 2 of the following: * Improvement in pain (WOMAC A) ≥20% and a 0.5 point absolute change in pain from Baseline on the 5-point Likert scale * Improvement in function (WOMAC C) ≥20% and a 0.5 point absolute change in function from Baseline on the 5-point Likert scale * Improvement in patient global assessment (PGA) ≥20% and a 0.5 point absolute change in function from Baseline on the 5-point Likert scale

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

168 participants

Primary outcome timeframe

Determined from Baseline to 12 Weeks

Results posted on

2022-08-09

Participant Flow

Participant milestones

Participant milestones
Measure	Ampion 4 mL Dose Ampion (\<5 kilodalton (kDa) ultrafiltrate of 5% Human Serum Albumin (HSA)), solution, 4 mL, single intra-articular injection Ampion: Ampion (\<5 kilodalton (kDa) ultrafiltrate of 5% HSA)	Saline 4 mL Dose Saline, solution, 4 mL, single intra-articular injection Saline: 0.9% sodium chloride
Overall Study STARTED	144	24
Overall Study COMPLETED	137	24
Overall Study NOT COMPLETED	7	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Ampion 4 mL Dose Ampion (\<5 kilodalton (kDa) ultrafiltrate of 5% Human Serum Albumin (HSA)), solution, 4 mL, single intra-articular injection Ampion: Ampion (\<5 kilodalton (kDa) ultrafiltrate of 5% HSA)	Saline 4 mL Dose Saline, solution, 4 mL, single intra-articular injection Saline: 0.9% sodium chloride
Overall Study Lost to Follow-up	2	0
Overall Study Adverse Event	2	0
Overall Study Withdrawal by Subject	3	0

Baseline Characteristics

AP-003-C Study to Confirm the Efficacy of Ampion™ in Adults With Pain Due to Severe Osteoarthritis of the Knee

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ampion 4 mL Dose n=144 Participants Ampion (\<5 kilodalton (kDa) ultrafiltrate of 5% Human Serum Albumin (HSA)), solution, 4 mL, single intra-articular injection Ampion: Ampion (\<5 kilodalton (kDa) ultrafiltrate of 5% HSA)	Saline 4 mL Dose n=24 Participants Saline, solution, 4 mL, single intra-articular injection Saline: 0.9% sodium chloride	Total n=168 Participants Total of all reporting groups
Age, Continuous	62.74 years STANDARD_DEVIATION 9.63 • n=39 Participants	64.04 years STANDARD_DEVIATION 6.25 • n=41 Participants	62.92 years STANDARD_DEVIATION 9.22 • n=35 Participants
Sex: Female, Male Female	76 Participants n=39 Participants	12 Participants n=41 Participants	88 Participants n=35 Participants
Sex: Female, Male Male	68 Participants n=39 Participants	12 Participants n=41 Participants	80 Participants n=35 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=39 Participants	1 Participants n=41 Participants	6 Participants n=35 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	139 Participants n=39 Participants	23 Participants n=41 Participants	162 Participants n=35 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=39 Participants	0 Participants n=41 Participants	1 Participants n=35 Participants
Race (NIH/OMB) Asian	3 Participants n=39 Participants	1 Participants n=41 Participants	4 Participants n=35 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Black or African American	27 Participants n=39 Participants	6 Participants n=41 Participants	33 Participants n=35 Participants
Race (NIH/OMB) White	111 Participants n=39 Participants	16 Participants n=41 Participants	127 Participants n=35 Participants
Race (NIH/OMB) More than one race	2 Participants n=39 Participants	1 Participants n=41 Participants	3 Participants n=35 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Region of Enrollment United States	144 Participants n=39 Participants	24 Participants n=41 Participants	168 Participants n=35 Participants
WOMAC Pain	2.5 score on a scale STANDARD_DEVIATION 0.56 • n=39 Participants	2.4 score on a scale STANDARD_DEVIATION 0.45 • n=41 Participants	2.5 score on a scale STANDARD_DEVIATION 0.55 • n=35 Participants
WOMAC Function	2.6 score on a scale STANDARD_DEVIATION 0.53 • n=39 Participants	2.5 score on a scale STANDARD_DEVIATION 0.53 • n=41 Participants	2.6 score on a scale STANDARD_DEVIATION 0.53 • n=35 Participants
Patient's Global Assessment (PGA)	2.8 score on a scale STANDARD_DEVIATION 0.80 • n=39 Participants	2.7 score on a scale STANDARD_DEVIATION 0.75 • n=41 Participants	2.8 score on a scale STANDARD_DEVIATION 0.79 • n=35 Participants

PRIMARY outcome

Timeframe: Determined from Baseline to 12 Weeks

Population: Intent to Treat (ITT)

Outcome measures

Outcome measures
Measure	Ampion 4 mL Dose n=144 Participants Ampion (\<5 kilodalton (kDa) ultrafiltrate of 5% Human Serum Albumin (HSA)), solution, 4 mL, single intra-articular injection Ampion: Ampion (\<5 kilodalton (kDa) ultrafiltrate of 5% HSA)	Saline 4 mL Dose n=24 Participants Saline, solution, 4 mL, single intra-articular injection Saline: 0.9% sodium chloride
Number of Participants Classified as Responders	102 Participants	15 Participants

Adverse Events

Ampion 4 mL Dose

Serious events: 0 serious events

Other events: 52 other events

Deaths: 0 deaths

Saline 4 mL Dose

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

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

Measure	Ampion 4 mL Dose n=144 participants at risk Ampion (\<5 kilodalton (kDa) ultrafiltrate of 5% Human Serum Albumin (HSA)), solution, 4 mL, single intra-articular injection Ampion: Ampion (\<5 kilodalton (kDa) ultrafiltrate of 5% HSA)	Saline 4 mL Dose n=24 participants at risk Saline, solution, 4 mL, single intra-articular injection Saline: 0.9% sodium chloride
General disorders Influenza-like illness	0.00% 0/144 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication	4.2% 1/24 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication
General disorders Injection site joint pain	0.00% 0/144 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication	4.2% 1/24 • 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	0.69% 1/144 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication	4.2% 1/24 • 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 Viral upper respiratory tract infection	2.8% 4/144 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication	0.00% 0/24 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication
Injury, poisoning and procedural complications Fall	1.4% 2/144 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication	0.00% 0/24 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication
Injury, poisoning and procedural complications Procedural pain	1.4% 2/144 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication	0.00% 0/24 • 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	13.2% 19/144 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication	8.3% 2/24 • 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 Arthropathy	1.4% 2/144 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication	0.00% 0/24 • 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 stiffness	2.1% 3/144 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication	8.3% 2/24 • 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	2.8% 4/144 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication	0.00% 0/24 • 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 Osteoarthritis	1.4% 2/144 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication	0.00% 0/24 • 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 Pain in extremity	1.4% 2/144 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication	0.00% 0/24 • 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 Synovial cyst	1.4% 2/144 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication	0.00% 0/24 • 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) Basal cell carcinoma	2.1% 3/144 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication	4.2% 1/24 • 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	2.8% 4/144 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication	0.00% 0/24 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication
Gastrointestinal disorders Nausea	1.4% 2/144 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication	0.00% 0/24 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication