A Study to Understand How Nerandomilast Works in People With Active Idiopathic Inflammatory Myopathies

Conditions

• Idiopathic Inflammatory Myopathies

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Placebo — DRUG
  Placebo-matching nerandomilast
• Nerandomilast — DRUG
  Nerandomilast

Study Details

This study is open to adults aged 18 and older who have a condition known as active idiopathic inflammatory myopathy (IIM) or myositis. People can participate if they have a specific type of myositis. The purpose of this study is to find out whether a medicine called nerandomilast improves IIM symptoms. Participants are put into 2 groups randomly, which means by chance. One group takes nerandomilast tablets and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Participants take nerandomilast or placebo twice a day for 1 year. Participants are in the study for about 1 year and 2 months. During this time, they visit the study site at least 16 times. During this time, doctors regularly check the participant's health, IIM symptoms, and take note of any unwanted effects. Participants fill in questionnaires about their IIM symptoms and how IIM impacts their quality of life. The results are compared between the 2 groups to see whether the treatment works.

Key Dates

First listed

Aug 27, 2026

Start date

Nov 9, 2026

Status verified

Aug 2026

Primary completion

Mar 21, 2030

Completion

Mar 26, 2030

Study Design

Enrollment

270 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Nerandomilast
• Placebo Comparator: Placebo
  Placebo matching nerandomilast

Primary Outcome Measure

Total improvement score (TIS) score (continuous) at Week 52 [ Time Frame: At Week 52. ]

Central Contacts

• Boehringer Ingelheim
  1-800-243-0127
  [email protected]

Locations (17)

Find similar trials in Phoenix, AZ

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