Trial Outcomes & Findings for A Study to Evaluate Safety of Three Intra-articular Injections of Ampion in the Knee of Adults With Osteoarthritis Pain (NCT NCT02184156)

NCT ID: NCT02184156

Last Updated: 2022-09-30

Results Overview

Incidence and severity of adverse events and serious adverse events evaluated at 24 weeks

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

47 participants

Primary outcome timeframe

24 Weeks

Results posted on

2022-09-30

Participant Flow

Recruitment of subjects for Phase 1 occurred in June and July 2014. Recruitment for Phase 2 occurred in medical clinics during the months of August, September, and October 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 4mL 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 4 mL placebo intra-articular injection Placebo: Saline
Phase 1 Safety STARTED	7	0
Phase 1 Safety COMPLETED	7	0
Phase 1 Safety NOT COMPLETED	0	0
Phase 2 20 Week Efficacy STARTED	20	20
Phase 2 20 Week Efficacy COMPLETED	19	19
Phase 2 20 Week Efficacy NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Ampion 4mL 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 4 mL placebo intra-articular injection Placebo: Saline
Phase 2 20 Week Efficacy Protocol Violation	0	1
Phase 2 20 Week Efficacy Withdrawal by Subject	1	0

Baseline Characteristics

Phase 1 was a safety study that did not study efficacy. Thus, this baseline measure was not collected.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1 - Ampion 4 mL Injection n=7 Participants Non-Randomized; 4 mL Intra-articular injection of Ampion	Phase 2 - Ampion 4 mL Injection n=20 Participants 4 mL Intra-articular injection of Ampion	Phase 2 - Placebo 4 mL Injection n=20 Participants 4 mL placebo intra-articular injection Placebo: Saline	Total n=47 Participants Total of all reporting groups
Race (NIH/OMB) White	7 Participants n=7 Participants	17 Participants n=20 Participants	20 Participants n=20 Participants	44 Participants n=47 Participants
Race (NIH/OMB) More than one race	0 Participants n=7 Participants	3 Participants n=20 Participants	0 Participants n=20 Participants	3 Participants n=47 Participants
Age, Continuous	65.1 Years STANDARD_DEVIATION 9.8 • n=7 Participants	63.7 Years STANDARD_DEVIATION 10.3 • n=20 Participants	61.4 Years STANDARD_DEVIATION 9.4 • n=20 Participants	62.9 Years STANDARD_DEVIATION 9.8 • n=47 Participants
Sex: Female, Male Female	1 Participants n=7 Participants	12 Participants n=20 Participants	13 Participants n=20 Participants	26 Participants n=47 Participants
Sex: Female, Male Male	6 Participants n=7 Participants	8 Participants n=20 Participants	7 Participants n=20 Participants	21 Participants n=47 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=7 Participants	2 Participants n=20 Participants	1 Participants n=20 Participants	3 Participants n=47 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=7 Participants	18 Participants n=20 Participants	19 Participants n=20 Participants	44 Participants n=47 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=7 Participants	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=47 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=7 Participants	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=47 Participants
Race (NIH/OMB) Asian	0 Participants n=7 Participants	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=47 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=7 Participants	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=47 Participants
Race (NIH/OMB) Black or African American	0 Participants n=7 Participants	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=47 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=7 Participants	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=47 Participants
Region of Enrollment United States	7 participants n=7 Participants	20 participants n=20 Participants	20 participants n=20 Participants	47 participants n=47 Participants
Kellgren-Lawrence (KL) Grade Kellgren-Lawrence Grade II	0 Participants n=7 Participants	2 Participants n=20 Participants	0 Participants n=20 Participants	2 Participants n=47 Participants
Kellgren-Lawrence (KL) Grade Kellgren-Lawrence Grade III	4 Participants n=7 Participants	11 Participants n=20 Participants	12 Participants n=20 Participants	27 Participants n=47 Participants
Kellgren-Lawrence (KL) Grade Kellgren-Lawrence Grade IV	3 Participants n=7 Participants	7 Participants n=20 Participants	8 Participants n=20 Participants	18 Participants n=47 Participants
Weight	188.9 Pounds STANDARD_DEVIATION 35.2 • n=7 Participants	197.6 Pounds STANDARD_DEVIATION 44.7 • n=20 Participants	193.8 Pounds STANDARD_DEVIATION 44.4 • n=20 Participants	194.7 Pounds STANDARD_DEVIATION 42.5 • n=47 Participants
BMI	27.2 lbs/in^2 STANDARD_DEVIATION 4.6 • n=7 Participants	29.8 lbs/in^2 STANDARD_DEVIATION 5.1 • n=20 Participants	29.9 lbs/in^2 STANDARD_DEVIATION 4.9 • n=20 Participants	29.5 lbs/in^2 STANDARD_DEVIATION 4.9 • n=47 Participants
WOMAC Pain	—	2.23 score on a scale STANDARD_DEVIATION 0.47 • n=20 Participants • Phase 1 was a safety study that did not study efficacy. Thus, this baseline measure was not collected.	2.17 score on a scale STANDARD_DEVIATION 0.44 • n=20 Participants • Phase 1 was a safety study that did not study efficacy. Thus, this baseline measure was not collected.	2.21 score on a scale STANDARD_DEVIATION 0.46 • n=40 Participants • Phase 1 was a safety study that did not study efficacy. Thus, this baseline measure was not collected.
WOMAC Function	—	2.17 score on a scale STANDARD_DEVIATION 0.50 • n=20 Participants • Phase 1 was a safety study that did not study efficacy. Thus, this baseline measure was not collected.	2.30 score on a scale STANDARD_DEVIATION 0.52 • n=20 Participants • Phase 1 was a safety study that did not study efficacy. Thus, this baseline measure was not collected.	2.24 score on a scale STANDARD_DEVIATION 0.51 • n=40 Participants • Phase 1 was a safety study that did not study efficacy. Thus, this baseline measure was not collected.

PRIMARY outcome

Timeframe: 24 Weeks

Population: Safety Population

Incidence and severity of adverse events and serious adverse events evaluated at 24 weeks

Outcome measures

Outcome measures
Measure	Phase 1 - Ampion 4 mL Injection n=15 events Non-Randomized; 4 mL Intra-articular injection of Ampion	Placebo 4 mL Injection 4 mL placebo intra-articular injection Placebo: Saline
Incidence and Severity of Adverse Events and Serious Adverse Events (Phase 1) Serious Adverse Event	0 events	—
Incidence and Severity of Adverse Events and Serious Adverse Events (Phase 1) Any Adverse Event	15 events	—

PRIMARY outcome

Timeframe: Scored at Baseline and 20 Weeks

Population: Intent to Treat (ITT)

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.

Outcome measures

Outcome measures
Measure	Phase 1 - Ampion 4 mL Injection n=20 Participants Non-Randomized; 4 mL Intra-articular injection of Ampion	Placebo 4 mL Injection n=20 Participants 4 mL placebo intra-articular injection Placebo: Saline
Change in Knee Pain (Phase 2)	-1.41 score on a scale Standard Deviation 0.81	-0.85 score on a scale Standard Deviation 0.64

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	Phase 1 - Ampion 4 mL Injection n=20 Participants Non-Randomized; 4 mL Intra-articular injection of Ampion	Placebo 4 mL Injection n=20 Participants 4 mL placebo intra-articular injection Placebo: Saline
Change in Knee Function (Phase 2)	-1.27 score on a scale Standard Deviation 0.81	-0.98 score on a scale Standard Deviation 0.69

Adverse Events

Ampion 4 mL (Phase 1)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Ampion 4 mL (Phase 2)

Serious events: 3 serious events

Other events: 19 other events

Deaths: 0 deaths

Placebo 4 mL (Phase 2)

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ampion 4 mL (Phase 1) n=7 participants at risk Non-Randomized; 4 mL Intra-articular injection of Ampion	Ampion 4 mL (Phase 2) n=20 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 (Phase 2) n=20 participants at risk 4 mL placebo intra-articular injection Placebo: Saline
Injury, poisoning and procedural complications Post Procedural Haemorrhage	0.00% 0/7 • 24 Weeks Patients will be followed for the occurrence of Adverse Events until 24 weeks after the first dose of study medication	5.0% 1/20 • 24 Weeks Patients will be followed for the occurrence of Adverse Events until 24 weeks after the first dose of study medication	0.00% 0/20 • 24 Weeks Patients will be followed for the occurrence of Adverse Events until 24 weeks after the first dose of study medication
Skin and subcutaneous tissue disorders Eczema	0.00% 0/7 • 24 Weeks Patients will be followed for the occurrence of Adverse Events until 24 weeks after the first dose of study medication	5.0% 1/20 • 24 Weeks Patients will be followed for the occurrence of Adverse Events until 24 weeks after the first dose of study medication	0.00% 0/20 • 24 Weeks Patients will be followed for the occurrence of Adverse Events until 24 weeks after the first dose of study medication
Nervous system disorders Embolic stroke	0.00% 0/7 • 24 Weeks Patients will be followed for the occurrence of Adverse Events until 24 weeks after the first dose of study medication	5.0% 1/20 • 24 Weeks Patients will be followed for the occurrence of Adverse Events until 24 weeks after the first dose of study medication	0.00% 0/20 • 24 Weeks Patients will be followed for the occurrence of Adverse Events until 24 weeks after the first dose of study medication

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