Study on GSK3858279 for Adults with Moderate to Severe Knee Osteoarthritis Pain

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for knee osteoarthritis pain, a condition that causes discomfort and stiffness in the knee joint due to the breakdown of cartilage. The treatment being tested is an injection called GSK3858279, developed by GlaxoSmithKline. This study aims to evaluate how effective and safe this treatment is in reducing pain for adults who experience moderate to severe knee pain due to osteoarthritis.

Participants in the study will receive either the GSK3858279 injection or a placebo, which is a substance with no active medication. The study is designed to be “double-blind,” meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo, to ensure unbiased results. The study will last for a period of up to 16 weeks, during which participants will receive regular injections and have their pain levels monitored and recorded.

The main goal of the study is to determine if GSK3858279 can effectively reduce knee pain compared to the placebo. Participants will be asked to report their pain levels using a simple scale, and these reports will help researchers understand the treatment’s impact. This study is an important step in finding new ways to manage pain for those suffering from knee osteoarthritis.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, your eligibility will be confirmed based on specific criteria, such as age, knee pain severity, and overall health.

You will be asked to provide informed consent, which means you agree to participate in the study after understanding all the details and requirements.

2 baseline assessment

A baseline assessment will be conducted to record your current knee pain levels. This involves using a tool called the Numeric Rating Scale (NRS) to rate your pain.

This assessment helps to establish a starting point for measuring changes in your pain over the course of the study.

3 randomization and treatment

You will be randomly assigned to receive either the study medication, GSK3858279, or a placebo. A placebo is a substance with no active medication, used for comparison.

The medication is administered as a subcutaneous injection, which means it is injected under the skin. The dosage and frequency will be determined by the study protocol.

4 ongoing assessments

Throughout the study, you will have regular assessments to monitor your knee pain and overall health. These assessments will occur at scheduled intervals.

You will be required to use a patient eDiary to record your daily pain levels and any other relevant information as instructed.

5 final assessment

At the end of the study period, a final assessment will be conducted to evaluate changes in your knee pain compared to the baseline assessment.

This assessment will help determine the effectiveness of the study medication in managing knee osteoarthritis pain.

Who Can Join the Study?

Participant must be between 40 and 80 years old at the time of signing the consent form.
Participant must have had symptoms of knee osteoarthritis for at least 6 months, with a clinical diagnosis according to the American College of Rheumatology (ACR) criteria.
Participant must have a Kellgren and Lawrence (KL) score of 2 or higher on an X-ray of the knee. This score is used to measure the severity of osteoarthritis.
Participant must have a pain score between 4 and 9 on a scale from 0 to 10 for average daily pain in the knee over the past 24 hours at the screening visit.
Participant must have an average pain score between 4 and 9 on the same 0 to 10 scale over the 7 days before starting the study.
Participant must be willing and able to understand and take part in all scheduled evaluations and complete all required tests and procedures, including using a patient eDiary.
Participant must have a Body Mass Index (BMI) of less than 40 kg/m². BMI is a measure of body fat based on height and weight.
Participant can be male or female. Female participants must not be pregnant or breastfeeding and must meet certain conditions regarding pregnancy prevention if they are of childbearing potential. Male participants with partners who are of childbearing potential must use a condom during sexual intercourse throughout the study and for 16 weeks after the last dose of the study intervention.
Participant must be capable of giving signed informed consent, which includes agreeing to follow the requirements and restrictions of the study.

Who Cannot Join the Study?

Patients with any other type of arthritis besides knee osteoarthritis.
Individuals who have had knee surgery in the past 6 months.
People currently using strong pain medications, like opioids, for knee pain.
Patients with a history of allergic reactions to similar medications.
Individuals with severe heart, liver, or kidney problems.
Women who are pregnant or breastfeeding.
Participants in another clinical trial within the last 30 days.
People with a history of drug or alcohol abuse.
Individuals with uncontrolled high blood pressure.
Patients with a history of cancer in the last 5 years, except for skin cancer that is not melanoma.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Instituto Hispalense De Pediatria S.L.	Sevilla	Spain

Other Sites

Site Name	City	Country
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Assistance Publique Hopitaux De Paris	Paris	France
Hospital Hm Nou Delfos	Barcelona	Spain
Centre Hospitalier De Dax	Dax	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Charite Research Organisation GmbH	Berlin	Germany
Centre Hospitalier Jean Rougier	Cahors	France
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis	La Rochelle	France
Eap Osona Sud Alt Congost S.L.P.	Centelles	Spain
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH	Hamburg	Germany
Smo Md GmbH	Magdeburg	Germany
Alm Lh Rqso dtu Vlnflc	La Roca del Valles	Spain
Pbnoso fgno Kzmjrgbws Sgisamy Dh mqs Ahjbd uxz Da mou Gfrjg Dycqel	Hamburg	Germany
Hhkaqlgv Uagcbdxegmdfr Msjghws Dy Vuihwxfuvs	Santander	Spain
Fmuiniglt Phmb Lw Igobatsbnkrxo Bkjlprmvi Dfn Hjtxzabx Urprcuxsaljqe Ll Pzh	Madrid	Spain
Rwihsqobqdxkvwvb Sfvjltjcxdmhuoxza Dbt Jwkkcl Wevciw	Rendsburg	Germany
Iczmrhjg dz Cafhyocqfjsy Hjaqlspabpp Uhzizhtfsulox dk Ssyvf Eimwtxw (lqoigvn	Saint Priest En Jarez	France
Hfhdrqtf Usodgmhgudpaq dt A Ctsjhp	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	18.12.2023
Germany	Not recruiting	18.12.2023
Spain	Not recruiting	18.12.2023

Trial locations

Investigated drugs:

Gsk3858279

GSK3858279 is a medication being studied for its potential to relieve pain in people with knee osteoarthritis. Osteoarthritis is a condition that causes joints to become painful and stiff, and it often affects the knees. This medication is being tested to see if it can help reduce the pain that comes with this condition. The study is designed to find out how effective GSK3858279 is in easing knee pain compared to not taking the medication.

Investigated diseases:

Osteoarthritis

Knee Osteoarthritis – Knee osteoarthritis is a degenerative joint disease characterized by the breakdown of cartilage in the knee joint. As the cartilage wears away, bones begin to rub against each other, causing pain, swelling, and reduced motion in the joint. Over time, the joint may become stiff and lose its normal shape. Small bone growths, called osteophytes or bone spurs, may form around the joint. The condition typically progresses slowly, with symptoms worsening over years. It is most common in older adults and can be influenced by factors such as age, weight, and previous joint injuries.

Trial ID:

2022-502799-22-00

Protocol code:

209978

NCT ID:

NCT05838742

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on GSK3858279 for Adults with Moderate to Severe Knee Osteoarthritis Pain

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