Study of PF-06823859 for Adults with Active Cutaneous or Systemic Lupus Erythematosus with Skin Symptoms

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What is this study about?

This clinical trial is focused on studying two types of lupus: Cutaneous Lupus Erythematosus (CLE) and Systemic Lupus Erythematosus (SLE), both of which can cause skin problems. The study is testing a new treatment called PF-06823859, which is a special type of protein known as a humanised IgG1k monoclonal antibody. This protein is designed to target and block a substance in the body called interferon beta, which is thought to play a role in lupus. Participants in the study will receive either the PF-06823859 treatment or a placebo, which looks like the treatment but does not contain the active substance.

The purpose of the study is to see how well PF-06823859 works in reducing the activity of lupus in the skin. Participants will be randomly assigned to receive either the treatment or the placebo. The study will last for several weeks, during which participants will receive the treatment through an injection into a vein, known as intravenous administration. Throughout the study, participants will have regular check-ups to monitor their health and the effects of the treatment.

By the end of the study, researchers hope to understand more about the safety and effectiveness of PF-06823859 in treating skin symptoms of lupus. This information could help in developing better treatments for people with CLE and SLE in the future.

1 joining the study

Upon joining the study, participants are required to meet specific criteria, including age and health conditions related to lupus.

Participants must have a confirmed diagnosis of active cutaneous lupus erythematosus (CLE) or systemic lupus erythematosus (SLE) with skin symptoms.

2 initial assessment

An initial assessment is conducted to identify four skin lesions for potential biopsies.

Participants must avoid applying topical medications to these lesions until after Week 32.

3 treatment administration

Participants receive either the study drug PF-06823859 or a placebo through intravenous administration.

The study drug is a solution for injection, specifically a humanized monoclonal antibody targeting interferon beta.

4 monitoring and follow-up

Regular visits are scheduled to monitor the participant’s health and response to the treatment.

Blood samples are taken to assess the effect of the treatment on the type 1 IFN GS score at Week 12.

5 evaluation of results

The primary goal is to observe changes in the type 1 IFN GS score in the skin at Week 12.

Secondary evaluations include changes in skin lesion scores and overall health assessments over time.

6 completion of the study

The study is expected to conclude by November 2026.

Participants’ health and any side effects are monitored throughout the study duration.

Who Can Join the Study?

Participants must be men or women aged between 18 and 75 years old.
Participants should be willing and able to attend all scheduled visits, follow the treatment plan, undergo laboratory tests, and follow lifestyle guidelines and other study procedures.
Participants must agree not to use any skin medications on specific skin areas (called index lesions) that might be used for biopsies until after Week 32 of the study.
Participants need to have suitable veins for receiving the study treatment through an IV (intravenous) and for taking blood samples during the study.
Participants must have a confirmed diagnosis of active Cutaneous Lupus Erythematosus (CLE) or Systemic Lupus Erythematosus (SLE) with skin symptoms, even after using standard treatments for at least 12 weeks. This includes having a certain score on a skin assessment and a past skin biopsy report available. The types of lupus include:
- Subacute cutaneous lupus erythematosus
- Discoid lupus erythematosus with at least one active lesion (certain types of lesions are not considered for eligibility but do not exclude participation)
- Both subacute and chronic cutaneous lupus erythematosus
Participants may be currently taking a stable dose of certain medications that suppress the immune system, or other specific medications, with or without antimalarials and/or corticosteroids. If taking corticosteroids, the dose must be between 5 and 10 mg per day.
Participants must weigh more than 40 kg and less than 130 kg, and have a Body Mass Index (BMI) of less than 40 kg/m².

Who Cannot Join the Study?

Having an active form of Cutaneous Lupus Erythematosus (CLE) or Systemic Lupus Erythematosus (SLE) with skin symptoms. Cutaneous Lupus Erythematosus is a type of lupus that affects the skin, and Systemic Lupus Erythematosus is a more widespread form of lupus that can affect multiple parts of the body, including the skin.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Andreas Syngros Hospital Of Venereal And Dermatological Diseases	Athens	Greece
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Hohdewfx Vpnr dfxoafhx	Barcelona	Spain
Uxcmbgugru Giapzth Hkasewfh Aypxgqm	Athens	Greece

Trial status

Country	Status	Recruitment Start
Greece	Not recruiting	15.10.2023
Spain	Not recruiting	15.10.2023

Trial locations

Investigated drugs:

Humanised Igg1K Monoclonal Antibody Against Interferon Beta

PF-06823859 is an investigational medication being studied for its potential effects on skin symptoms in people with CLE (cutaneous lupus erythematosus) or SLE (systemic lupus erythematosus) with skin involvement. The trial aims to understand how this medication affects certain immune system markers and its overall safety and effectiveness in reducing skin-related symptoms of these conditions.

Investigated diseases:

Cutaneous Lupus Erythematosus (CLE) – This is a chronic autoimmune disease that primarily affects the skin, leading to rashes, lesions, and other skin abnormalities. The condition can cause red, scaly patches or ring-shaped lesions, often on sun-exposed areas like the face, neck, and arms. Over time, these skin changes can lead to scarring and changes in skin pigmentation. The disease may fluctuate, with periods of flare-ups and remission. It is part of a broader group of lupus conditions, but it specifically targets the skin.

Systemic Lupus Erythematosus (SLE) with Cutaneous Manifestations – This is a complex autoimmune disease that can affect multiple organs and systems in the body, including the skin. When it involves the skin, it can cause rashes, lesions, and other dermatological symptoms similar to those seen in Cutaneous Lupus Erythematosus. The skin manifestations can vary widely, from mild rashes to more severe lesions. The disease is characterized by periods of activity and remission, with symptoms potentially affecting other parts of the body as well. Skin involvement is a common feature, but SLE can also impact joints, kidneys, and other organs.

Trial ID:

2023-503343-33-00

Protocol code:

C0251013

NCT ID:

NCT05879718

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of PF-06823859 for Adults with Active Cutaneous or Systemic Lupus Erythematosus with Skin Symptoms

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