Europas førende søgning efter kliniske forsøg

His203-Crm197

Clinical trials investigating His203-Crm197 are studying whether it can help people with inflammatory knee osteoarthritis. The main goals are to check safety and whether it improves pain and physical function. The trial data shown here includes adults with knee osteoarthritis in a phase 2 study.

Table of contents

Trial overview

The available trial data describes one phase 2 study of His203-Crm197 in people with inflammatory knee osteoarthritis.[1] The study is authorised and planned to include 204 participants.[1]

The trial title says it is a randomized, double-blind, placebo-controlled, multicenter study that is evaluating the safety and efficacy of PPV-06 active immunotherapy in patients with inflammatory knee osteoarthritis (KOA).[1]

Study design and groups

This study is randomized, which means people are assigned to study groups by chance.[1] It is also double-blind, so the participants and the study team do not know who receives the active treatment and who receives placebo during the trial.[1]

The study is placebo-controlled, so one group receives matching placebo instead of the active study treatment.[1] It is also multicenter, meaning it is carried out at more than one study site.[1]

The intervention list includes PPV-06 given by subcutaneous injection, matching placebo, and Panodil, filmovertrukne tabletter, given by mouth.[1] The trial data provided does not explain the role of Panodil in the study beyond listing it as an intervention.[1]

Who can participate

The study is for participants with knee osteoarthritis.[1] The brief summary says the trial aims to evaluate efficacy in participants with knee OA, which is another way of saying knee osteoarthritis.[1]

The provided trial data does not give the full list of inclusion or exclusion criteria, so it is not possible to say more about who can join from this source alone.[1]

What is being measured

The main outcome measures are changes from the start of the study to Week 54 in the WOMAC pain subscale and the WOMAC physical function subscale.[1] WOMAC is a questionnaire used in osteoarthritis studies to measure pain and how well a person can do daily activities.[1]

The pain subscale includes 5 items, and the physical function subscale includes 17 items.[1] In simple terms, the study wants to see whether treatment changes how much pain people have and how well they can move and carry out everyday tasks.[1]

The trial title also says the study is evaluating safety and efficacy.[1] Safety means checking whether the treatment can be used without causing unacceptable harm, and efficacy means checking whether it works as intended.[1]

Key terms explained

Osteoarthritis is a joint disease that can cause pain and difficulty moving, and this study focuses on the knee.[1] Inflammatory means that inflammation is part of the condition being studied.[1]

Enrollment means the number of people planned for the study, which is 204 here.[1] The study status is authorised, meaning it has been approved to go ahead in the source data provided.[1]

Trial ID Phase Condition studied Status Enrollment
2024-514388-24-00 Phase 2 Knee osteoarthritis Authorised 204

FAQ

  • What is being studied in the His203-Crm197 trial? The trial is studying whether His203-Crm197 can improve pain and physical function in people with inflammatory knee osteoarthritis. It is also looking at safety.
  • Who can take part in the study? The study is for participants with knee osteoarthritis. The trial data does not give more detailed entry rules here.
  • What phase is the trial? This is a phase 2 trial. Phase 2 studies usually look more closely at whether a treatment may work and continue to check safety.
  • What does the study compare? The study is randomized and double-blind, and it compares His203-Crm197 with matching placebo. It is also multicenter, which means it is run at more than one study site.
  • What results are the researchers measuring? The main results are changes in WOMAC pain and WOMAC physical function scores from the start of the study to Week 54. WOMAC is a questionnaire that measures osteoarthritis symptoms and daily function.

Igangværende kliniske forsøg for His203-Crm197

  • Afprøvning af PPV-06 behandling til lindring af smerter og forbedring af bevægelighed hos personer med slidgigt i knæet

    Rekrutterer endnu ikke

    1 1
    Undersøgte lægemidler:
    Tjekkiet Danmark Frankrig Polen Rumænien

Ordliste

  • Knee osteoarthritis: A joint disease in the knee that can cause pain, stiffness, and trouble moving.
  • Inflammatory knee osteoarthritis: A form of knee osteoarthritis where inflammation is part of the disease process.
  • Phase 2: A mid-stage clinical trial that looks at whether a treatment may work and continues to monitor safety.
  • Randomized: Participants are placed into study groups by chance, not by choice.
  • Double-blind: Neither the participants nor the study team know who gets the active treatment or placebo during the study.
  • Placebo: A treatment that looks like the study drug but does not contain the active treatment.
  • Multicenter: The study is carried out at more than one hospital or clinic.
  • WOMAC: A questionnaire used to measure pain, stiffness, and physical function in people with osteoarthritis.
  • Physical function: How well a person can do daily activities such as walking, standing, or using stairs.
  • Enrollment: The number of people planned to join the study.

Referencer

  1. https://clinicaltrials.gov/study/2024-514388-24-00