Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

C0251013 - A PHASE 2, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE CLINICAL EFFECT, PHARMACODYNAMIC, PHARMACOKINETIC AND SAFETY PROFILE OF PF-06823859 IN ADULT PARTICIPANTS WITH ACTIVE CLE OR SLE WITH CUTANEOUS MANIFESTATIONS

This study is looking into a new medicine, PF-06823859, for adults who have lupus that causes skin problems. This includes people with Active Cutaneous Lupus Erythematosus (CLE) or Systemic Lupus Erythematosus (SLE) where the skin is affected. The main goal is to find out if this medicine can help improve skin conditions and reduce the skin problems caused by lupus. Researchers will also check if the medicine is safe and how the body handles it. For comparison, some participants will receive the new medicine, while others will receive a placebo, which looks like the medicine but contains no active ingredients. This helps researchers understand the true effects of the new medicine.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Pfizer Inc.

Enrolment target

Start

02 Oct 2023

Active Cutaneous Lupus Erythematosus (CLE) or Systemic Lupus Erythematosus (SLE) With Cutaneous Manifestations

What is this study about?

This study is about a new medicine called PF-06823859. It's being tested for adults who have a type of lupus that causes skin problems. Lupus is a long-term condition that can affect many parts of the body. When it affects the skin, it can cause rashes, sores, and other issues. This study is aimed at people with Active Cutaneous Lupus Erythematosus (CLE) or Systemic Lupus Erythematosus (SLE) where their skin is currently affected.

The main thing the researchers want to find out is how well this new medicine helps to improve these skin problems. They will be looking closely at changes in the skin over 12 weeks. They will also be checking if the medicine is safe and how your body reacts to it. Because it's a 'Phase 2' study, it means they are still exploring the right dose and further checking its effects before it can be considered for wider use.

To make sure they get clear results, some people in the study will get the new medicine, and others will get a 'placebo'. A placebo looks exactly like the real medicine but doesn't have any active ingredients. This helps doctors see if the improvements are really due to the new medicine or if they might happen anyway. All participants will be carefully monitored throughout the study.

Key takeaways

This study is testing a new medicine for adults with lupus that affects their skin.
It aims to see if the medicine improves skin problems caused by lupus and if it's safe.
Some participants will receive the new medicine, while others will get a placebo.
Both men and women aged 18 and over are eligible to participate.
Participation involves regular clinic visits for checks, assessments, and taking the study medicine.
You can leave the study at any time if you wish.

Who may be eligible?

To join this study, you need to be an adult, aged 18 years or older. There is no upper age limit, meaning older adults can also take part.

Both men and women are welcome to participate in this study. The researchers want to include a wide range of people to understand how the medicine works across different individuals.

Crucially, you must have active lupus that is affecting your skin. This means you have ongoing skin problems caused by either Cutaneous Lupus Erythematosus (CLE) or Systemic Lupus Erythematosus (SLE). The study will have more specific medical checks to make sure you fit all the criteria. These will be discussed with you by the study doctor.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have lupus that is currently causing skin problems?
Are you willing to attend regular clinic visits and follow study instructions?
Are you able to take study medication as prescribed?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be seen regularly by the study team. You will have several visits to the clinic where doctors and nurses will check on your health and your skin. During these visits, they will do things like take blood samples and perform physical examinations. They will also check your heart with an electrocardiogram (ECG) and monitor your vital signs, like blood pressure.

You will receive either the new study medicine (PF-06823859) or a placebo, which looks like the medicine but has no active ingredients. You won't know which one you are getting, and neither will the study team, until the end of the study. You'll take this medicine for a set period, and there will be follow-up appointments to see how you are doing even after you stop taking the medicine.

Throughout the study, your skin will be carefully assessed to see if it's improving. The total time you'll be involved in the study, including all visits and follow-ups, will be explained in detail by the study team.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as receiving a new treatment for your lupus skin problems that is not yet widely available. You will also get close medical monitoring and care from a specialist team. However, there are also potential risks, as the new medicine might cause side effects, some of which might be unpleasant or unexpected. The study team will explain all known side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care if you decide it's not right for you.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain
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Unverified
Greece

Common questions

What is 'lupus with cutaneous manifestations'?

This refers to lupus, which is a condition where your immune system mistakenly attacks healthy tissues, causing problems; and 'cutaneous manifestations' means these problems show up on your skin, like rashes or sores.

What is a 'placebo'?

A placebo is a sham medicine that looks exactly like the real medicine but contains no active drug. It helps researchers compare the effects of the new medicine against having no drug at all.

Will I know if I'm getting the real medicine or the placebo?

No, this is a 'double-blind' study, meaning neither you nor the study doctors will know whether you are receiving the active medicine or the placebo. This helps ensure fair and unbiased results.

How long will I be in the study?

The study aims to observe changes in your skin over a period of 12 weeks, but the total duration of your participation, including screening and follow-up visits, will be explained by the study team.

Can I stop participating in the study if I want to?

Yes, you have the right to leave the study at any time, for any reason. Your decision will not affect your future medical care.