Active not recruitingPHASE2INTERVENTIONAL

A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE)

This research study is looking into a new medicine, IMVT-1402, for individuals in the UK living with certain types of lupus that mainly affect the skin, called Subacute Cutaneous Lupus Erythematosus (SCLE) or Chronic Cutaneous Lupus Erythematosus (CCLE). The main goal is to find out if this new medicine is safe to use and how well people tolerate it. Researchers also want to see if IMVT-1402 is effective at reducing skin symptoms compared to a 'placebo' – a dummy treatment with no active medicine. The study involves different periods where participants will receive either the investigational medicine or a placebo, with the overall study lasting for about 61 weeks.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Immunovant Sciences GmbH

Enrolment target

Start

19 Feb 2025

Estimated completion

01 Apr 2027

Subacute Cutaneous Lupus Erythematosus Chronic Cutaneous Lupus Erythematosus

What is this study about?

This study is investigating a new medicine called IMVT-1402 for people who have lupus affecting their skin. Specifically, it's for those with 'Subacute Cutaneous Lupus Erythematosus' (SCLE) or 'Chronic Cutaneous Lupus Erythematosus' (CCLE). These are conditions where your immune system mistakenly attacks healthy skin, leading to rashes and other skin problems.

The main aim of this research is to understand if IMVT-1402 can safely and effectively improve these skin symptoms. Researchers will also be checking if participants experience any side effects and how well their bodies tolerate the new medicine. This is a 'Phase 2' study, which means it's an earlier stage of research designed to gather more information about the medicine's effectiveness and safety before potentially moving to larger studies.

Taking part in studies like this is really important because it helps scientists find new and better ways to treat conditions like cutaneous lupus. By comparing the new medicine to a 'placebo' (a dummy treatment), researchers can get a clearer picture of whether IMVT-1402 genuinely helps improve the condition.

Key takeaways

This study evaluates a new medicine (IMVT-1402) for skin lupus (SCLE or CCLE).
It aims to check the medicine's safety, how well it's tolerated, and if it improves skin symptoms.
Participants will receive either the active medicine or a placebo (dummy medicine) for parts of the study.
The total time commitment for the study is about 61 weeks.
Regular clinic visits and skin assessments will be part of the participation.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you must be 18 years or older and have a confirmed diagnosis of either Subacute Cutaneous Lupus Erythematosus (SCLE) or Chronic Cutaneous Lupus Erythematosus (CCLE). This diagnosis usually needs to have been confirmed by a skin biopsy. Your skin lupus should also be active, even though you might have tried other standard medicines already. Additionally, you would need to show certain levels of skin activity based on a specific scoring system used by the study team, and have certain antibodies in your blood.

However, there are reasons why you might not be able to join. For example, if your lupus was caused by a medicine, or if you have certain other conditions like rapidly worsening kidney problems or another inflammatory skin condition that might make it hard to accurately assess your lupus symptoms. The research team will go through all the detailed criteria with you to make sure the study is right for you and you meet all the necessary requirements.

Quick self-check

Are you 18 years or older?
Do you have a doctor-confirmed diagnosis of SCLE or CCLE?
Are your skin lupus symptoms currently active, even if you've tried other treatments?
Do you have any other inflammatory skin conditions (like eczema or psoriasis) that might get in the way of assessing your lupus?
Are you able to attend regular clinic visits for about 61 weeks?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, your journey will last for a total of about 61 weeks (just over a year). Here's a general idea of what it would involve:

For the first 12 weeks (Period 1), you would be randomly assigned to receive either the study medicine, IMVT-1402, or a placebo (a dummy medicine). You wouldn't know which one you're getting, and neither would the study doctors. Both are given as an injection under the skin once a week.

After these 12 weeks, if you completed Period 1, you would then enter Period 2. For the next 14 weeks, everyone in this period would receive IMVT-1402 as a weekly injection under the skin.

Finally, in Period 3, which lasts for 26 weeks, you would again be randomly assigned to receive one of two different doses of IMVT-1402. Again, this would be a weekly injection under the skin, and it would be 'blinded,' meaning you wouldn't know which dose you're on. Throughout the study, you would have regular clinic visits for health checks, blood tests, and assessments of your skin lupus to see how you're doing.

Potential risks and benefits

Taking part in a clinical trial like this could offer potential benefits, such as gaining access to a new medicine that isn't yet widely available, and closely monitored medical care throughout the study. However, like all medicines, IMVT-1402 may have side effects, and some people may not experience any improvement in their condition. There's also a chance you might receive the placebo for part of the study. All potential risks and side effects will be fully explained to you before you decide to participate. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (86)

Site Number - 1010
Anniston, United States
Site Number - 1020
Birmingham, United States
Site Number - 1038
Phoenix, United States
Site Number - 1034
Scottsdale, United States
Site Number - 1022
Beverly Hills, United States
Site Number - 1018
Chula Vista, United States
Site Number - 1039
Corona, United States
Site Number - 1005
Fremont, United States
Site Number - 1023
Los Angeles, United States
Site Number - 1000
Aurora, United States
Site Number - 1033
Castle Rock, United States
Site Number - 1021
Farmington, United States

+74 more sites — see the official record for the full list.

Common questions

What is lupus?

Lupus is a long-term condition where your body's immune system, which normally fights off infections, attacks healthy tissues and organs instead. This study focuses on lupus that affects the skin.

What is a placebo?

A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active ingredients. It helps researchers compare the new medicine's effects accurately.

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

For most of this study, neither you nor your doctor will know whether you are receiving the active medicine or the placebo. This is to ensure fair and unbiased results.

How is the medicine given?

The study medicine, IMVT-1402, is given as an injection under the skin, once a week.

How long will I be in the study?

If you join the study, your participation would last for approximately 61 weeks, which is about one year and two months.