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NCT07497087 · ClinicalTrials.gov registry record · Phase 3
A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Not yet
- Registry status
- Phase 3
- Development phase
- 448
- Enrollment target
NCT07497087: Clinical Trial Phase 3 study, sponsored by Boehringer Ingelheim.
NCT07497087 is a Phase 3 study that has not yet begun recruiting, run by Boehringer Ingelheim. The registered enrollment target is 448 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07497087, a Phase 3 study, has not yet begun recruiting, sponsored by Boehringer Ingelheim.
- NOT YET RECRUITING
- Registry status
- Phase 3
- Development phase
- 448 participants
- Enrollment target
Study Summary
Nerandomilast is being developed to help people with systemic sclerosis by potentially improving symptoms and slowing disease progression. This study is open to adults who are at least 18 years old and have systemic sclerosis (SSc). People can join the study if they have limited or diffuse cutaneous SSc with disease onset within 7 years of the first non-Raynaud's symptom. The purpose of this study is to find out whether a medicine called nerandomilast helps people with systemic sclerosis. This study also aims to find out how well nerandomilast is tolerated in people with systemic sclerosis. 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 the tablets twice a day. Participants are in the study for 1 to about 4 years. During this time, they visit the study site regularly and get phone calls from the site staff. During study visits participants regularly have blood samples taken and doctors check changes in skin thickening, lung function, and internal organs, overall health and the safety and tolerability of study treatment in people with SSc. The results are compared between the groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.
Interventions
- DRUG Placebo matching nerandomilast formulation 1
- DRUG Placebo matching nerandomilast formulation 2
- DRUG Nerandomilast formulation 1
- DRUG Nerandomilast formulation 2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 448 participants |
| Start Date | 2026-07-10 |
| Est. Completion | 2030-03-17 |
| Phase | Phase 3 |
What is known before NCT07497087 opens enrollment
NCT07497087 is an interventional study that assigns participants to a tested intervention. The registered 448 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo matching nerandomilast formulation 1 is the first listed.
NCT07497087 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07497087 about?
NCT07497087 is a clinical study titled "A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis". Nerandomilast is being developed to help people with systemic sclerosis by potentially improving symptoms and slowing disease progression. This study is open to adults who are at least 18 years old and have systemic sclerosis (SSc). People can join the study if they have limited or diffuse cutaneous...
What is the current status of trial NCT07497087?
This trial is currently not yet recruiting. It is a Phase 3 study. The enrollment target is 448 participants. The study started on 2026-07-10. Estimated completion is 2030-03-17.
What interventions are being tested in trial NCT07497087?
The interventions under investigation include: Placebo matching nerandomilast formulation 1 (DRUG), Placebo matching nerandomilast formulation 2 (DRUG), Nerandomilast formulation 1 (DRUG), Nerandomilast formulation 2 (DRUG).
Who is sponsoring clinical trial NCT07497087?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07497087's enrollment target sits among peer trials
448 864th of 2000 higher than 1,137 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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