Hydrogel Assessment for Local Treatment of Osteoarthritis

NCT07516457 | Recruiting DMC

• 1 other identifier: DHF-001-DVaP-002-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

The study aims to evaluate the safety and tolerability of one intra-articular injection of Hydrogel OA 2% for the symptomatic treatment of osteoarthritis of the knee.

Conditions

Osteo Arthritis of the Knee

Keywords

osteoarthritis; knee

Outcome Measures

Primary Outcomes (1)

• Occurrence of Device- or Procedure-Related Serious Adverse Events

  Occurrence of any device or procedure related (serious) adverse event up to 13 weeks after injection of the investigational device.

  13 weeks

Secondary Outcomes (1)

• Occurrence of Device- or Procedure-Related Serious Adverse Events

  12 months

Study Arms (1)

Interventional

EXPERIMENTAL

Single Injection of Investigational Device

Device: Injection of Hydrogel OA 2%

Interventions

Injection of Hydrogel OA 2% DEVICE

Single injection

Interventional

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults accepting to participate in the study and having signed the written informed consent form before any protocol-specific procedures and able to understand and follow the instructions as described in the protocol.
• Unilateral symptomatic tibiofemoral KOA confirmed by a "stand-ing knee" X-ray. In case of bilateral KOA on X-ray only one knee (index knee) presents symptomatic OA pain.
• Age 35 ≤ 75 years.
• BMI 20 ≤ 35.
• Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain score 25 ≤ 70.
• Patients impacted by pain in the index knee during daily activi-ties.
• Radiological Kellgren and Lawrence (K\&L) grade II and III of the index knee from a standing knee radiograph assessed during the screening visit, using the most recent X-ray taken either im-mediately or within the past 3 months.
• Fully ambulatory for functional assessments.
• Willingness to refrain from taking any pain medication for 48 hours prior to investigational device injection on day 0.
• Female subjects must be on effective contraception (pill, patch, ring, diaphragm, implant or intrauterine device) and must perform a pregnancy test, of which the result must be negative, at the treatment visit unless they are surgically sterile (tubal ligation or hysterectomy) or postmenopausal for at least one year.

You may not qualify if:

• Bilateral tibiofemoral KOA where the non-index knee presents a worse radiological grade of KOA than the index knee.
• Significant clinically assessed varus or valgus deformation of the selected knee side of more than 10 degrees.
• Extension deficit of the index knee higher than 5 degrees.
• Bilateral symptomatic tibiofemoral KOA or combined ipsilateral symptomatic tibiofemoral knee and hip OA.
• Clinical signs of significant effusion with noticeable swelling and/or inflammation related to severe pain.
• Active lymphatic or venous stasis or serious blood disorders (e.g., anemia), bleeding disorders (e.g., hemophilia), blood clots, or blood cancers (e.g., leukemia, lymphoma, and myeloma).
• Active bacterial infection, resulting in hospitalization and/or requiring intravenous antibiotic treatment.
• Synovial infection, skin infection or skin diseases in the area of the injection site.
• History of autoimmune diseases that causes chronic joint pain and inflammation in the knee joint, including rheumatoid arthritis, psoriasis arthritis, juvenile idiopathic arthritis, systemic lupus erythematosus, gout, pseudogout, systemic sclerosis, Sjögren's disease, adult-onset still's disease.
• Known or suspected generalized chronic pain disorder.
• Severe alteration of mobility preventing any functional assessment.
• Allergy or hypersensitivity to any of the product components of Hydrogel OA 2%.
• Conditions (orthopedic, rheumatologic, musculoskeletal or inflammatory) causing symptomatic and/or radiating pain in the lower extremities that might interfere with the symptomatic OA knee pain, including hip OA assessed by physical examination by the physician.
• Symptomatic patellofemoral knee OA.
• Oral corticotherapy in the last 3 months before injection of the investigational device.

Sponsors & Collaborators

• Allegro NV/SA: lead

Study Sites (3)

AZ Sint Jan

Bruges, Belgium

RECRUITING

AZ Monica

Deurne, Belgium

RECRUITING

AZ Delta

Roeselare, Belgium

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Kris Van den Cruys

CONTACT

clinical@allegro.bio

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 8, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: May 11, 2026

Record last verified: 2026-05

Locations

BE (3)