A study testing brepocitinib compared to placebo for adults with dermatomyositis to see if it works and is safe

3 1

What is this study about?

This study is looking at a disease called dermatomyositis, which is a condition that causes muscle weakness and skin rashes. The study will test a medicine called brepocitinib, which is also known by its code name PVT-2201. This medicine works by blocking certain enzymes in the body that can cause inflammation. Some people in the study will receive brepocitinib while others will receive placebo. The purpose of the study is to find out if brepocitinib can help improve the symptoms of dermatomyositis compared to placebo after 52 weeks of treatment.

People taking part in this study must be adults between 18 and 75 years old who have been diagnosed with dermatomyositis and have active muscle and skin disease. Participants should have received or be receiving treatment with corticosteroids, hydroxychloroquine, or other medicines that affect the immune system. The study will measure improvement using a scoring system that looks at different aspects of the disease, including muscle strength, skin condition, overall health as rated by both the doctor and the patient, ability to perform daily activities, and levels of certain enzymes in the blood that indicate muscle damage.

During the study, participants will take their assigned medicine by mouth in tablet form for up to 114 days. The study will track various measures of improvement at different time points, with the main assessment happening at week 52. These measures include changes in skin disease activity scores, the proportion of people who show moderate or major improvement, how quickly improvement occurs, and changes in the ability to carry out daily activities. The study will also look at whether participants can reduce their dose of prednisone or similar corticosteroid medicines while still showing improvement.

1 Treatment period begins

At the start of the trial, you will be randomly assigned to receive either brepocitinib or placebo. A placebo is an inactive substance that looks like the actual medication but contains no active ingredient.

Neither you nor your doctor will know which treatment you are receiving during this period. This is called a double-blind study design.

You will receive the assigned treatment in the form of tablets that are taken by mouth.

2 Taking the study medication

You will take the study medication orally as tablets throughout the trial period.

The medication contains brepocitinib tosilate as the active ingredient, or it may be a placebo tablet if you are assigned to the placebo group.

Your doctor will provide specific instructions on how often to take the tablets and at what times of day.

3 Regular clinic visits during the first month

At Week 4, you will have a clinic visit where your doctor will assess changes in your skin condition.

Your skin disease activity will be measured using a scoring system called CDASI Activity Score, which evaluates the severity of skin symptoms related to dermatomyositis.

4 Ongoing treatment and monitoring

You will continue taking the study medication as prescribed throughout the trial.

During this period, you may continue receiving other medications you were taking before the trial, such as corticosteroids, hydroxychloroquine, or other medications that affect the immune system.

Regular visits will be scheduled to monitor your condition and any effects of the treatment.

5 Assessment at Week 48

At Week 48, your doctor will evaluate your overall improvement and check the dose of any corticosteroid medication you are taking.

If you are taking oral prednisone or an equivalent corticosteroid, the dose will be recorded to determine if it has been reduced to 2.5 milligrams per day or less.

6 Final assessment at Week 52

At Week 52, which marks the end of the main treatment period, you will undergo comprehensive assessments.

Your overall improvement will be measured using the Total Improvement Score, which combines six different measures including assessments by your doctor, your own assessment of your condition, muscle strength testing, ability to perform daily activities, muscle enzyme levels in your blood, and muscle disease activity.

Your skin condition will be assessed again using the CDASI Activity Score to measure changes from the beginning of the trial.

Another combined measure called DMOMS will be calculated, which includes muscle strength, skin condition, and assessments from both you and your doctor.

Your ability to perform daily activities will be evaluated using the HAQ Disability Index, which measures how easily you can complete everyday tasks.

If you are taking corticosteroids, the dose will be checked again to see if it remains at 2.5 milligrams per day or less.

7 Completion of the trial

After the Week 52 visit, the main part of the trial will be complete.

Your doctor will discuss the next steps in your care and any changes to your treatment plan.

Who Can Join the Study?

You must be between 18 and 75 years old when you sign the consent form to join the study
You must have a confirmed diagnosis of dermatomyositis, which is a condition that causes muscle weakness and skin rash, according to specific medical classification guidelines from 2017
You must have active muscle and skin disease at the time of screening and at the start of the study, meaning your symptoms are currently present
You must be currently taking or have previously taken corticosteroids (medications that reduce inflammation), hydroxychloroquine (a medication often used for inflammatory conditions), or at least one other medication that suppresses the immune system
Your body weight must be more than 40 kilograms but less than 130 kilograms
Your body mass index, which is a measure of body fat based on your height and weight, must be less than 40
Both men and women can participate in this study

Who Cannot Join the Study?

The source data does not provide specific exclusion criteria (reasons why a patient cannot participate in this study)
Without detailed exclusion criteria information, it is not possible to list the specific conditions or situations that would prevent participation in this clinical trial (a research study testing a new treatment)
Typically, exclusion criteria may include things like other serious health conditions, certain medications being taken, pregnancy or breastfeeding, recent vaccinations, or abnormal laboratory test results, but these specific details are not available in the provided information

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Spitalul Clinic Judetean De Urgenta Cluj	Cluj Napoca	Romania
Technische Universitaet Dresden	Dresden	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Ambulatories For Specialized Outpatient Medical Help Medical Center Kyuchuk Parizh OOD	Plovdiv	Bulgaria

Other Sites

Site Name	City	Country
Klimed MK Sp. z o.o.	Bialystok	Poland
University Of Pecs	Pecs	Hungary
Revmatologicky Ustav	Prague	Czechia
University Of Debrecen	Debrecen	Hungary
Medical Center Excelsior OOD	Sofia	Bulgaria
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD	Sofia	Bulgaria
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Medical Center Artmed Ltd.	Plovdiv	Bulgaria
Reum.hapi s.r.o.	Nove Mesto Nad Vahom	Slovakia
Saint Maria Hospital	Bucharest	Romania
Charite Research Organisation GmbH	Berlin	Germany
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital De Santa Maria E.P.E.	Lisbon	Portugal
Unidade Local De Saude De Gaia/Espinho E.P.E.	Vila Nova De Gaia	Portugal
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.	Cracow	Poland
Reumed Sp. z o.o.	Lublin	Poland
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.	Nowa Sol	Poland
University Multiprofile Hospital For Active Treatment Kaspela EOOD	Plovdiv	Bulgaria
University Of Szeged	Szeged	Hungary
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o.	Szczecin	Poland
University Hospital Consorziale Policlinico	Bari	Italy
Abewlykxh Uwv	Amsterdam	The Netherlands
Nhgkgyvj Iegcwpcl Gsivhkalq Rxfsescqsnyp I Rmedlhushztmz Ib Pwmmv Dq Hljd Mvww Ekzrfqdr Rhqsmoh	Warsaw	Poland
Ahwgspw Onbcapinlzh Uwkvcdskejdue Ciyfrbgmhlmw Dxocy Scncoz E Dyqbn Ssdnkuy Du Tmhjfk	Turin	Italy

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.11.2022
Bulgaria	Not recruiting	01.11.2022
Czechia	Not recruiting	01.11.2022
Germany	Not recruiting	01.11.2022
Hungary	Not recruiting	01.11.2022
Italy	Not recruiting	01.11.2022
Poland	Not recruiting	01.11.2022
Portugal	Not recruiting	01.11.2022
Romania	Not recruiting	01.11.2022
Slovakia	ended	01.11.2022
Spain	Not recruiting	01.11.2022
The Netherlands	Not recruiting	01.11.2022

Trial locations

Brepocitinib is an oral medication being tested in this study to treat dermatomyositis, which is a rare disease that causes muscle weakness and skin rash. This medicine is taken by mouth and works by affecting the immune system to help reduce inflammation in the muscles and skin.

Placebo is an inactive substance that looks like the real medication but contains no active medicine. It is used in this study to compare whether brepocitinib works better than no treatment at all.

Dermatomyositis – Dermatomyositis is a rare inflammatory disease that affects both the muscles and the skin. The condition causes muscle weakness, particularly in the muscles closest to the trunk of the body, such as those in the hips, thighs, shoulders, and neck. A distinctive skin rash typically appears, often affecting the face, eyelids, knuckles, elbows, knees, chest, and back. The muscle weakness tends to develop gradually over weeks to months, making it difficult to perform everyday activities like climbing stairs or lifting objects. The skin changes may appear before, after, or at the same time as the muscle symptoms. The disease progresses through periods of increased activity and remission, with symptoms varying in severity from person to person.

Trial ID:

2022-500367-12-00

Protocol code:

PVT-2201-301

NCT ID:

NCT05437263

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

A study testing brepocitinib compared to placebo for adults with dermatomyositis to see if it works and is safe

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?