A Trial to Investigate the Safety and Efficacy of Intra-articular 4P004 Injection in Subjects With Knee Synovitis and Osteoarthritis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-80
Sponsor4Moving Biotech
About this trial
This phase 2a trial is an international, multicenter, randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of one single intra-articular (IA) injection of 4P004 or placebo in:
* patients between 40 and 80 years of age, * with synovitis and grade 2 to 4 osteoarthritis (OA) of the knee according to Kellgren and Lawrence (KL) classification.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants who have the capacity to give informed consent and who are willing to comply with all trial related procedures and assessments.
Participants between 40 and 80 years of age.
Female participant of childbearing potential (defined as any woman unless postmenopausal for at least one year or surgically sterile) must use highly effective methods of contraception as defined in the protocol. Highly effective contraceptive measures must be continued throughout the trial until the final visit.
Bodyweight > 40 kg.
Disqualifiers
Pregnant or breastfeeding women.
Significant malalignment of anatomical axis (medial angle formed by the femur and tibia) of the TK (varus > 10°, valgus > 10°) by radiography.
Secondary OA such as joint dysplasia, aseptic osteonecrosis, joint infection, acromegaly, Paget disease, hemochromatosis, joint crystal disease or any inflammatory joint disease.
Any known active infections including skin infections at the site injection or increased predisposition for the development of infections.
Trial design
Design model
Parallel
Treatments tested in this trial
4P004
DrugSingle intra-articular injection in the knee joint
Placebo (NaCl 0.9%)
DrugSingle intra-articular injection in the knee joint
Treatment groups
129 Participants
are divided into 2 treatment groupsGroup A: 4P004 (2mL)Experimental treatment 1 intervention
Group B: Placebo (NaCl 0.9% 2mL)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline at Week 4 in the weekly average of Target Knee (TK) daily pain intensity using the WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain subscore
The WOMAC is a questionnaire widely used in the evaluation of knee osteoarthritis. It contains 24 items measuring 3 subscales: physical function (17 items), pain (5 items), and stiffness (2 items). Scores are calculated for each subscale and summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The sum of the scores for all three subscales gives a total WOMAC score. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time frame
Baseline and Week 4Secondary outcomes
1
Change from Baseline at Week 2, Week 6, Week 8, Week 10 and Week 12 in the weekly average of TK (Target Knee) daily pain intensity using the WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain subscore
The WOMAC is a questionnaire widely used in the evaluation of knee osteoarthritis. It contains 24 items measuring 3 subscales: physical function (17 items), pain (5 items), and stiffness (2 items). Scores are calculated for each subscale and summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The sum of the scores for all three subscales gives a total WOMAC score. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time frame
Baseline, Week 2, Week 6, Week 8, Week 10 and Week 122
Change from Baseline at Week 2, Week 4, Week 8 and Week 12 in the NRS (Numeric Rating Scale) pain (scale 0-10) in a nominated pain aggravating activity
The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time, using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable.
Time frame
Baseline, Week 2, Week 4, Week 8 and Week 123
Change from Baseline at Week 2, Week 4, Week 8 and Week 12 in WOMAC (Western Ontario and McMaster Universities Arthritis Index) subscores and total score
The WOMAC is a questionnaire widely used in the evaluation of knee osteoarthritis. It contains 24 items measuring 3 subscales: physical function (17 items), pain (5 items), and stiffness (2 items). Scores are calculated for each subscale and summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The sum of the scores for all three subscales gives a total WOMAC score. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time frame
Baseline, Week 2, Week 4, Week 8 and Week 124
Change from Baseline at Week 2, Week 4, Week 8 and Week 12 in the Patient Global Assessment of Osteoarthritis (PGA-OA)
The PGA-OA is a 1-item questionnaire designed to assess the participant's impression of disease severity adapted from Guy et al., 1976, to the specific disease as a Patient-reported Outcome measurement "Considering all the ways your knee osteoarthritis affects you, how are you doing these last seven days ?". PGA-OA is measured on a 5-point Likert scale, with higher scores indicating worse symptoms (1= "very good" to 5 = "very poor").
Time frame
Baseline, Week 2, Week 4, Week 8 and Week 12Sponsors and contacts
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Source ClinicalTrials.gov