Osteoarthritis (OA) of the KneePhase 2NCT06884865
A Study to Assess Safety and Tolerability of PCRX-201 in Subjects With Painful Osteoarthritis of the Knee
A Phase 2 study testing Enekinragene Inzadenovec (PCRX-201) in people with Osteoarthritis (OA) of the Knee, run by Pacira Pharmaceuticals, Inc at 40 sites in United States.
Trial summary
The goal of this clinical trial is to learn if a single knee injection of different doses (Dose A and Dose B) of an investigation product PCRX-201, following steroid pretreatment, is safe and tolerable in male of female patients 45 to 80 years old with osteoarthritis of the knee. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Osteoarthritis (OA) of the Knee
- What is being tested?
- Enekinragene Inzadenovec (PCRX-201)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 40 sitesUnited States
- Study dates
- 26 Feb 2025to Jul 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be willing and able to comply with the study procedures and visit schedule and able to follow verbal and written instructions.
- Subjects must be male or female and 45 to 80 years old, inclusive, at Screening.
- Subjects must exhibit symptoms associated with osteoarthritis of the index knee for ≥12 months before Screening (subject self-reporting is acceptable).
- Subjects must have index knee pain for >15 days over the last month before Screening (subject self-reporting is acceptable).
- Subjects must have received 2 or more failed 2 or more therapies: Restricted physical activity as per Osteoarthritis Research Society International (OARSI) core level recommendation, ie, "structured land-based exercise" (this may include physical therapy), and failure of an additional type of conservative therapy for OA of the index knee, eg, nonselective NSAIDs or COX-2 inhibitors, in the past 12 months.
- Subjects must have a body mass index (BMI) ≤40 kg/m2 at Screening.
Show all 16Show fewer
- Subjects must have an index knee examination indicating the index knee and the intended injection site area are free of any signs of local or joint infection at Baseline.
- Subjects must have an index knee Average Daily Knee Pain (NRS) between ≥5.0 and ≤9.0 at Screening and Baseline.
- Sexually active subjects of child-bearing potential (SOCBP) and their partners must agree to use effective birth control while in the study
- Subjects must have active synovitis in the index knee as determined by ultrasound Doppler (Part A only) For Part B, participants must have active synovitis in the index knee as determined by contrast-enhanced MRI.
- Subjects must exhibit American College of Rheumatology Criteria (clinical and radiological) for osteoarthritis as follows:
- Knee pain
- At least 1 of the following:
- Age >50 years ii. Morning stiffness <30 minutes iii. Crepitus on knee motion c. Osteophytes
- Subjects must have K-L Grade 2, 3, or 4 (Part A) or K-L Grade 2 or 3 (Part B) in the index knee based on X-rays performed during Screening and confirmed by trained radiographers at a central facility before enrollment
- Subjects need to show the presence of moderate or severe synovitis based on 11-point synovitis score using contrast-enhanced MRI (Part A). For Part B, participants need to show the presence of synovitis ≥5 on the Guermazi synovitis scoring scale using contrast-enhanced MRI to be enrolled.
Who cannot join
- Subjects have any current or prior diagnosis of autoimmune connective tissue disorders, secondary OA conditions, benign synovial tumors, gout/pseudogout, reactive arthritis, RA, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease.
- Subjects have any active systemic or local infection, including infection of the index knee
- Subjects are unable to undergo MRI with contrast MRI
- Subjects with X-ray or MRI exclusionary events
- Subjects have an unstable index knee joint (eg, torn anterior cruciate ligament) within 12 months of Screening
- Subjects have used any approved or investigational IA drug/biologic in index knee within 6 months of Screening (eg, hyaluronic acid, platelet rich plasma, stem cells, prolotherapy, and amniotic fluid injection)
Show all 10Show fewer
- Subjects are receiving or have received any gene therapy treatment (eg, IL-1Ra) in the past 3 years
- Subjects have used IA steroids ≤3 months before screening
- For Part B, subjects with any surgery related tot he index knee.
- Other protocol-defined criteria apply
Trial locations and contacts
40 sites in 1 country. Contact the study team or a site near you to ask about taking part.
40 sites in 1 country
United States40 sites, 27 recruiting
- Not yet recruiting
University Orthopedics Center
Altoona, Pennsylvania, 16602-4472
Jill Fremberg, 814-272-3691, jfremberg@uoc.com
Thomas Ellis
- Not yet recruiting
Pinnacle Trials, Inc.
Atlanta, Georgia, 30329
Robert Robbins, 404-929-6774, robert.robbins@trypinnacle.com
Francisco Chevres
- Not yet recruiting
LifeBridge Health
Baltimore, Maryland, 21215
Taj Jamal Andrews, tandrews@lifebridgehealth.org
Michael Mont
- Active, not recruiting
Osteoporosis Medical Center
Beverly Hills, California, 90211
- Not yet recruiting
Flourish Research - Birmingham
Birmingham, Alabama, 35205
Melissa Martin, 205 327 1077, mmartin@flourishresearch.com
Kenneth Jaffe
- Withdrawn
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, 35235
- Not yet recruiting
NY Scientific
Brooklyn, New York, 11235-3919
Mohammed Hossain, 347-547-6972, mhossain@nyscientific.net
Alexander Brun
- Active, not recruiting
Clinical Trials of South Carolina - Charleston
Charleston, South Carolina, 29406
- Not yet recruiting
Rush Medical College - Division of Rheumatology
Chicago, Illinois, 60612
Joshlean Fair, 312-563-2955, Joshlean_Fair@rush.edu
Joel Block
- Not yet recruiting
Advanced Clinical Research Center, LLC dba TriWest Research Associates, LLC
Chula Vista, California, 91910
Daniela Cardenas, dcardenas@triwestresearch.com
Arthur Mabaquiao
- Not yet recruiting
Campbell Clinic
Collierville, Tennessee, 38017
Margaret Knack, mknack@campbell-foundation.org
William Mihalko
- Active, not recruiting
Clinical Trials of South Carolina - Columbia
Columbia, South Carolina, 29206
- Not yet recruiting
Medvin Clinical Research - Covina
Covina, California, 91722
Rosalia Thanory, 626-869-5730, rosalia@medvinresearch.com
Samy Metyas
- Active, not recruiting
Zenos Clinical Research
Dallas, Texas, 75230
- Not yet recruiting
Helios CR, Inc.
Dallas, Texas, 75231
Sammi Swaim, sammi.swaim@heliosclinical.com
Stanley Cohen
- Not yet recruiting
META Medical Research Institute
Dayton, Ohio, 45432
Benu Kulkarni, bkulkarni@metamedresearch.com
Priyesh Mehta
- Recruiting
Arrow Clinical Trials
Daytona Beach, Florida, 32117
Vinoothna Moluguri, vmoluguri@arrowtrials.com
David Billmeier
- Active, not recruiting
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
- Not yet recruiting
Accurate Clinical Research, Inc - Houston
Houston, Texas, 77034
Philip Waller
- Recruiting
Beach Physicians Medical Group Inc.
Huntington Beach, California, 92647
Kim Zepeda, 714-848-1655 ext. 124, kzepeda@beachphysicians.com
Bassil Aish
- Active, not recruiting
Horizon Clinical Research
La Mesa, California, 91942
- Not yet recruiting
Accurate Clinical Research, Inc. - Lake Charles
Lake Charles, Louisiana, 70605
Enrique Mendez
- Active, not recruiting
Excel Clinical Research
Las Vegas, Nevada, 89109
- Active, not recruiting
Epic Clinical Research
Lewisville, Texas, 75057
- Recruiting
Physicians Research Collaboration
Lincoln, Nebraska, 68516
Brittany Presnell, Brittany.Presnell@prc.us.com
Melvin Churchill
- Not yet recruiting
West Clinical Research
Morehead City, North Carolina, 28557
Millicent Clark, millicent.clark@westclinicalresearch.com
Jeffrey Moore
- Not yet recruiting
Best Clinical Trials, LLC
New Orleans, Louisiana, 70115
Mary Lalla Lane, mjlallabct@gmail.com
Neil Duplantier
- Not yet recruiting
New York University (NYU) Center for Musculoskeletal Care
New York, New York, 10016
Nathan Han, Nathan.Han@nyulangone.org
Jonathan Samuels
- Active, not recruiting
Journey Research Inc.
Oldsmar, Florida, 34677-4681
- Not yet recruiting
OrthoArizona
Phoenix, Arizona, 85018
Robert Wallace, 800-774-1534 ext. 711, r.wallace@prgresearch.com
Kipling Sharpe
- Not yet recruiting
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix
Phoenix, Arizona, 85032
Nathaly Navarro, Nathaly.Navarro@aaracr.com
Eric Peters
- Not yet recruiting
Discovery Health Research Center - Plantation, FL
Plantation, Florida, 33317
Joel Hernandez, jhernandez@discoveryhealthresearch.com
Conrad Ziembinski
- Not yet recruiting
Michigan Orthopaedic and Spine Surgeons
Rochester Hills, Michigan, 48307
Cecile Pestano, cecilern@mossdocs.net
Nathan Rimmke
- Not yet recruiting
Source Healthcare
Santa Monica, California, 90403
Gabriel Wirnowski, gabriel@sourcehealthcare.com
Timothy Davis
- Not yet recruiting
Gulfcoast Research Institute
Sarasota, Florida, 34232
Jesse D'Alessio, 941-552-7875, jdalessio@gulfcoast-research.com
Edward Stolarski
- Withdrawn
Alliance Clinical West Hills (Focus Clinical Research)
West Hills, California, 91307
- Active, not recruiting
Palm Beach Research Center
West Palm Beach, Florida, 33409
- Not yet recruiting
Medvin Clinical Research - Whittier
Whittier, California, 90602
Tien-I Karleen Su
- Not yet recruiting
M3 Wake Research - Wilmington, NC
Wilmington, North Carolina, 28412
Jeremy Hoff
- Active, not recruiting
Conquest Research
Winter Park, Florida, 32789
About this study
Official title: A Phase 2, Two-Part, Randomized, Double-Blind, Active-Controlled Study to Assess the Safety and Tolerability of Enekinragene Inzadenovec (PCRX-201) in Subjects With Painful Osteoarthritis of the Knee
The goal of this clinical trial is to learn if a single knee injection of different doses (Dose A and Dose B) of an investigation product PCRX-201, following steroid pretreatment, is safe and tolerable in male of female patients 45 to 80 years old with osteoarthritis of the knee. It will also learn how the body reacts to the PCRX-201 injection and how effective the treatment is.
Researchers will compare Dose A and Dose B of PCRX-201 versus placebo from Week 1 through Week 52 to assess adverse events. Researchers will also explore how PCRX-201 may impact knee pain and joint function over time.
Read more
Participants will be asked to
- Visit the clinic for pretreatment and drug administration
- Visit the clinic for checkups and tests:
- Screening through Week 52: intially weekly, bi-weekly, later monthly
- Week 53 through Week 260 (Year 5): 8 visits throughout the period
Read the detailed description
The study will consist of two parts, Part A and Part B, which will use PCRX-201 from two different manufacturing processes. A total of 135 eligible subjects, with painful OA of the index knee will be enrolled. Subjects will be randomly assigned to a treatment dose group, stratified by Kellgren-Lawrence (K-L) Grade, in both parts of the study. Enrollment of subjects with K-L Grade 4 will be capped at 4 subjects per dose group in Part A and 8 subjects per dose group in Part B.
Enrollment of subjects with K-L Grade 2 or 3 will include a minimum of 4 subjects per Grade per dose group in Part A and a minimum of 8 subjects per Grade per dose group in Part B. This study does not require an equal number of subjects between K-L Grade 2 and 3. All eligible subjects will be pretreated with the same dose of methylprednisolone acetate (40 mg) on Day 1 immediately before treatment with PCRX-201 or placebo.
Part A will enroll approximately 45 subjects into 3 dose groups (15 subjects in each treatment group, stratified by K-L Grade as noted above).
Part B will enroll approximately 90 subjects into 3 groups (30 subjects in each treatment group, stratified by K-L Grade as noted above). Enrollment in Part B is dependent upon the availability of study drug developed with manufacturing process 2.
- Conditions
- Osteoarthritis (OA) of the Knee
- Being tested
- Enekinragene Inzadenovec (PCRX-201), Placebo
- Keywords
- gene therapy, Knee Pain Arthritis, Osteoarthritis of the Knee
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enekinragene Inzadenovec (PCRX-201)Biological
Enekinragene Inzadenovec (PCRX-201) injection
PlaceboBiological
Placebo injection
| Study group | Role | What they receive |
|---|---|---|
| Part A Dose A | Experimental | Single Intra-Articular injection Receives: Biological: Enekinragene Inzadenovec (PCRX-201) |
| Part A, Placebo | Placebo comparator | Single Intra-Articular injection Receives: Biological: Placebo |
| Part B Dose A | Experimental | Single Intra-Articular injection Receives: Biological: Enekinragene Inzadenovec (PCRX-201) |
| Part B Dose B | Experimental | Single Intra-Articular injection Receives: Biological: Enekinragene Inzadenovec (PCRX-201) |
| Part B Placebo | Placebo comparator | Part B Placebo Receives: Biological: Placebo |
| Part A, Dose B | Experimental | Single Intra-Articular injection Receives: Biological: Enekinragene Inzadenovec (PCRX-201) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence (number and percent) of treatment-emergent adverse events (TEAEs) for PCRX-201 Dose A and Dose B versus placebo from Week 1 through Week 52
Measured: Week 1 through Week 52.
Incidence (number and percent) of adverse events of special interest (AESIs) for PCRX-201 Dose A and Dose B versus placebo from Week 1 through Week 52
Measured: Week 1 through Week 52.
Incidence (number and percent) of serious adverse events (SAEs) for PCRX-201 Dose A and Dose B versus placebo from Week 1 through Week 52
Measured: Week 1 through Week 52.
Secondary outcomes (8)
Real-time quantitative polymerase chain reaction (qPCR) measurement profile in plasma of PCRX-201 Dose A and Dose B from postdose through Week 8
Measured: Days 1, 4, Weeks 2, 4, 8
Real-time qPCR measurement profile of skin swab samples from Baseline through Week 4.
Measured: Days 1, 4, Weeks 2, 4
Assessment of the levels of neutralizing antibodies (NAbs), high-sensitivity C-reactive protein (hs-CRP), and biomarkers of inflammation (eg, interleukin [IL]- 1, cytokines [tumor necrosis factor alpha (TNFα), IL-1β, IL-6, IL-10], and chemokines [IL-8])
Measured: Days 1, 4, Weeks 2, 3, 4,12, 16, 24, 38
Absolute change from baseline in Average Daily Knee Pain (Numerical Rating Scale [NRS]) for PCRX-201 Dose A and Dose B versus placebo.
Measured: Weeks 38 and 52
Absolute change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score for PCRX-201 Dose A and Dose B versus placebo.
Measured: Weeks 38 and 52
Absolute change from baseline in WOMAC Stiffness Score for PCRX-201 Dose A and Dose B versus placebo.
Measured: Weeks 38 and 52
Absolute change from baseline in WOMAC Physical Function Score for PCRX-201 Dose A and Dose B versus placebo.
Measured: Weeks 38 and 52
Absolute change from Baseline on the Knee Injury and Osteoarthritis Outcome Score (KOOS) function/daily living score for PCRX-201 Dose A and Dose B versus placebo at Weeks 38 and 52.
Measured: Weeks 38 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start26 Feb 2025
- Primary completionNov 2026 (estimated)
- Study completionJul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis (OA) of the KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In Part A (manufacturing process 1), subjects are randomized in a 1:1:1 ratio to Dose A , Dose B , or placebo, each with a predose IA steroid of methylprednisolone acetate. In Part B (manufacturing process 2), subjects are randomized in a 1:1:1 ratio to Dose A, Dose B, or placebo, each with a pre-dose IA steroid of methylprednisolone acetate.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Warrren Rizzo, MD, Study director, Pacira Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06884865
- Sponsor's protocol ID
- 201-C-201
- Status last verified
- Aug 2026
- First submitted
- 13 Mar 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Two-Part, Randomized, Double-Blind, Active-Controlled Study to Assess the Safety and Tolerability of Enekinragene Inzadenovec (PCRX-201) in Subjects With Painful Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT06884865
- Acronym / sponsor ID
- 201-C-201
- Conditions
- Osteoarthritis (OA) of the Knee
- Keywords
- gene therapy, Knee Pain Arthritis, Osteoarthritis of the Knee
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Jul 2032 (estimated)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if a single knee injection of different doses (Dose A and Dose B) of an investigation product PCRX-201, following steroid pretreatment, is safe and tolerable in male of female patients 45 to 80 years old with osteoarthritis of the knee. It will also learn how the body reacts to the PCRX-201 injection and how effective the treatment is.
Researchers will compare Dose A and Dose B of PCRX-201 versus placebo from Week 1 through Week 52 to assess adverse events. Researchers will also explore how PCRX-201 may impact knee pain and joint function over time.
Participants will be asked to
- Visit the clinic for pretreatment and drug administration
- Visit the clinic for checkups and tests:
- Screening through Week 52: intially weekly, bi-weekly, later monthly
- Week 53 through Week 260 (Year 5): 8 visits throughout the period
Detailed description
The study will consist of two parts, Part A and Part B, which will use PCRX-201 from two different manufacturing processes. A total of 135 eligible subjects, with painful OA of the index knee will be enrolled. Subjects will be randomly assigned to a treatment dose group, stratified by Kellgren-Lawrence (K-L) Grade, in both parts of the study. Enrollment of subjects with K-L Grade 4 will be capped at 4 subjects per dose group in Part A and 8 subjects per dose group in Part B.
Enrollment of subjects with K-L Grade 2 or 3 will include a minimum of 4 subjects per Grade per dose group in Part A and a minimum of 8 subjects per Grade per dose group in Part B. This study does not require an equal number of subjects between K-L Grade 2 and 3. All eligible subjects will be pretreated with the same dose of methylprednisolone acetate (40 mg) on Day 1 immediately before treatment with PCRX-201 or placebo.
Part A will enroll approximately 45 subjects into 3 dose groups (15 subjects in each treatment group, stratified by K-L Grade as noted above).
Part B will enroll approximately 90 subjects into 3 groups (30 subjects in each treatment group, stratified by K-L Grade as noted above). Enrollment in Part B is dependent upon the availability of study drug developed with manufacturing process 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- In Part A (manufacturing process 1), subjects are randomized in a 1:1:1 ratio to Dose A , Dose B , or placebo, each with a predose IA steroid of methylprednisolone acetate. In Part B (manufacturing process 2), subjects are randomized in a 1:1:1 ratio to Dose A, Dose B, or placebo, each with a pre-dose IA steroid of methylprednisolone acetate.
| Arm | Type | Receives |
|---|---|---|
| Part A Dose A | Experimental | Biological: Enekinragene Inzadenovec (PCRX-201)Single Intra-Articular injection |
| Part A, Placebo | Placebo comparator | Biological: PlaceboSingle Intra-Articular injection |
| Part B Dose A | Experimental | Biological: Enekinragene Inzadenovec (PCRX-201)Single Intra-Articular injection |
| Part B Dose B | Experimental | Biological: Enekinragene Inzadenovec (PCRX-201)Single Intra-Articular injection |
| Part B Placebo | Placebo comparator | Biological: PlaceboPart B Placebo |
| Part A, Dose B | Experimental | Biological: Enekinragene Inzadenovec (PCRX-201)Single Intra-Articular injection |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Subjects must be willing and able to comply with the study procedures and visit schedule and able to follow verbal and written instructions.
- Subjects must be male or female and 45 to 80 years old, inclusive, at Screening.
- Subjects must exhibit symptoms associated with osteoarthritis of the index knee for ≥12 months before Screening (subject self-reporting is acceptable).
- Subjects must have index knee pain for >15 days over the last month before Screening (subject self-reporting is acceptable).
- Subjects must have received 2 or more failed 2 or more therapies: Restricted physical activity as per Osteoarthritis Research Society International (OARSI) core level recommendation, ie, "structured land-based exercise" (this may include physical therapy), and failure of an additional type of conservative therapy for OA of the index knee, eg, nonselective NSAIDs or COX-2 inhibitors, in the past 12 months.
Key exclusion criteria (10 listed)
- Subjects have any current or prior diagnosis of autoimmune connective tissue disorders, secondary OA conditions, benign synovial tumors, gout/pseudogout, reactive arthritis, RA, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease.
- Subjects have any active systemic or local infection, including infection of the index knee
- Subjects are unable to undergo MRI with contrast MRI
- Subjects with X-ray or MRI exclusionary events
- Subjects have an unstable index knee joint (eg, torn anterior cruciate ligament) within 12 months of Screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enekinragene Inzadenovec (PCRX-201)Enekinragene Inzadenovec (PCRX-201) injection | Biological | Part A Dose A, Part A, Dose B, Part B Dose A, Part B Dose B |
| PlaceboPlacebo injection | Biological | Part A, Placebo, Part B Placebo |
Primary outcome
Incidence (number and percent) of treatment-emergent adverse events (TEAEs) for PCRX-201 Dose A and Dose B versus placebo from Week 1 through Week 52
Time frame: Week 1 through Week 52.
Incidence (number and percent) of adverse events of special interest (AESIs) for PCRX-201 Dose A and Dose B versus placebo from Week 1 through Week 52
Time frame: Week 1 through Week 52.
Incidence (number and percent) of serious adverse events (SAEs) for PCRX-201 Dose A and Dose B versus placebo from Week 1 through Week 52
Time frame: Week 1 through Week 52.
8 secondary outcomes
Real-time quantitative polymerase chain reaction (qPCR) measurement profile in plasma of PCRX-201 Dose A and Dose B from postdose through Week 8
Time frame: Days 1, 4, Weeks 2, 4, 8
Real-time qPCR measurement profile of skin swab samples from Baseline through Week 4.
Time frame: Days 1, 4, Weeks 2, 4
Assessment of the levels of neutralizing antibodies (NAbs), high-sensitivity C-reactive protein (hs-CRP), and biomarkers of inflammation (eg, interleukin [IL]- 1, cytokines [tumor necrosis factor alpha (TNFα), IL-1β, IL-6, IL-10], and chemokines [IL-8])
Time frame: Days 1, 4, Weeks 2, 3, 4,12, 16, 24, 38
Absolute change from baseline in Average Daily Knee Pain (Numerical Rating Scale [NRS]) for PCRX-201 Dose A and Dose B versus placebo.
Time frame: Weeks 38 and 52
Absolute change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score for PCRX-201 Dose A and Dose B versus placebo.
Time frame: Weeks 38 and 52
Absolute change from baseline in WOMAC Stiffness Score for PCRX-201 Dose A and Dose B versus placebo.
Time frame: Weeks 38 and 52
Absolute change from baseline in WOMAC Physical Function Score for PCRX-201 Dose A and Dose B versus placebo.
Time frame: Weeks 38 and 52
Absolute change from Baseline on the Knee Injury and Osteoarthritis Outcome Score (KOOS) function/daily living score for PCRX-201 Dose A and Dose B versus placebo at Weeks 38 and 52.
Time frame: Weeks 38 and 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Warrren Rizzo, MD study director
Pacira Pharmaceuticals, Inc
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Enekinragene Inzadenovec (PCRX-201) in people with Osteoarthritis (OA) of the Knee, run by Pacira Pharmaceuticals, Inc at 40 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Ramsay, MA (973-451-4019, lisa.ramsay@pacira.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence (number and percent) of treatment-emergent adverse events (TEAEs) for PCRX-201 Dose A and Dose B versus placebo from Week 1 through Week 52 (time frame: Week 1 through Week 52.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.