Zinc Oxide

Clinical trials for Zinc Oxide are not shown in the source data provided here. The trial records available instead study dapirolizumab pegol in people with systemic lupus erythematosus, with goals such as long-term safety and treatment response. These studies focus on adults with moderately to severely active SLE.

Table of contents

Trial overview

The source data provided for this article does not include any clinical trials of Zinc Oxide. Instead, it includes two studies of dapirolizumab pegol in people with systemic lupus erythematosus (SLE).[1][2]

Both studies are marked Authorised and both are Phase 3 interventional trials, which means they are later-stage studies that test treatment effects in people.[1][2]

Condition studied

The condition studied in both trials is systemic lupus erythematosus, a long-term disease in which the immune system attacks the body’s own tissues.[1][2]

One trial focuses on people with moderately to severely active disease, meaning the lupus activity is at a noticeable or serious level.[1]

The second trial looks at people with SLE more broadly and is designed to study long-term safety and tolerability.[2]

Trial design and phase

Both studies are interventional, so participants receive a study treatment and the results are measured over time.[1][2]

The first trial has an enrollment of 459 people, and the second trial has an enrollment of 765 people.[1][2]

The first study evaluates dapirolizumab pegol as an add-on to standard of care, which means the usual treatment people already receive.[1]

The second study also includes dapirolizumab pegol and measures long-term safety outcomes during the study.[2]

Main outcomes being measured

The first study’s main outcome is BICLA response at Week 48, which is a lupus disease activity measure used to see whether the disease has improved.[1]

The second study focuses on safety outcomes, including the incidence of treatment-emergent adverse events, serious treatment-emergent adverse events, and adverse events that lead to permanent discontinuation of dapirolizumab pegol.[2]

In simple terms, the researchers are checking both whether treatment helps and whether people can use it safely over time.[1][2]

Who the studies are for

The target population in both records is people with systemic lupus erythematosus.[1][2]

One study is aimed at people with moderately to severely active SLE, while the other is aimed at people with SLE who are being followed for longer-term safety.[1][2]

What this means for readers

Based on the source data, there are no trial records here for Zinc Oxide.[1][2]

The available records are still useful because they show how clinical trials are described: by condition, phase, enrollment, design, and the main outcomes being measured.[1][2]

Trial ID Phase Condition studied Status Enrollment
2023-508191-11-00 Phase 3 Systemic lupus erythematosus (SLE) Authorised 459
NCT04976322 Phase 3 Systemic lupus erythematosus (SLE) Authorised 765

Ongoing Clinical Trials on Zinc Oxide

  • Study on the Effectiveness and Safety of Dapirolizumab Pegol for Patients with Moderate to Severe Systemic Lupus Erythematosus

    Recruiting

    3 1 1
    Investigated diseases:
    Belgium Denmark France Germany Greece Italy +3
  • Study on the Long-Term Safety of Dapirolizumab Pegol for Patients with Systemic Lupus Erythematosus

    Recruiting

    3 1 1 1
    Belgium Bulgaria Czechia Denmark France Germany +7

Glossary

  • Systemic lupus erythematosus (SLE): A long-term disease in which the immune system attacks the body's own tissues and can affect many organs.
  • Moderately to severely active: A way to describe how strong the disease is. It means the illness is causing a noticeable to serious level of symptoms or activity.
  • Phase 3: A later stage of clinical research that studies how well a treatment works and how safe it is in a larger group of people.
  • Interventional study: A study where participants receive a treatment or placebo so researchers can compare outcomes.
  • Placebo: A treatment that looks like the study drug but has no active substance.
  • Standard of care: The usual treatment or routine medical care that people normally receive for a condition.
  • Primary outcome: The main result the researchers plan to measure to answer the study question.
  • BICLA response: A clinical response measure used in lupus studies to show improvement in disease activity.
  • Treatment-emergent adverse events (TEAEs): Unwanted medical problems that start or get worse after treatment begins.
  • Tolerability: How well people can handle a treatment without serious problems.

References