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NCT05559580 · ClinicalTrials.gov registry record · Phase 2
A Study in People With Systemic Sclerosis to Test Whether Avenciguat (BI 685509) Has an Effect on Lung Function and Other Systemic Sclerosis Symptoms
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 214
- Enrollment target
NCT05559580: Completed Phase 2 study, sponsored by Boehringer Ingelheim.
NCT05559580 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 214 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05559580, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 214 participants
- Enrollment target
Study Summary
This study is open to adults aged 18 and older or above legal age who have systemic sclerosis. People can participate if they have a specific subtype called diffuse cutaneous systemic sclerosis. People with another subtype called limited cutaneous systemic sclerosis can also participate if they are anti Scl-70 antibody positive. Systemic sclerosis is also called scleroderma. The purpose of this study is to find out whether a medicine called Avenciguat (BI 685509) helps people with scleroderma who have symptoms due to lung fibrosis or vascular problems. Participants are put into 2 groups by chance. One group takes Avenciguat (BI 685509) tablets 3 times a day and the other group takes placebo tablets 3 times a day. Placebo tablets look like BI 685509 tablets but do not contain any medicine. Participants take the tablets for at least 11 months. Afterwards, participants can continue to take the tablets until the last participant has completed the 11-months treatment period. This means that the time in the study and duration of treatment is different for each participant, depending on when they start the study. At the beginning of the study, participants visit the study site every 2 weeks. The time between the visits to the study site gets longer over the course of the study. After the 11-months treatment period, participants visit the study site every 3 months. During the study, participants regularly do lung function tests. The results are compared between the 2 groups to see whether the treatment works. The participants also regularly fill in questionnaires about their scleroderma symptoms. The doctors regularly check participants' skin condition and general health and take note of any unwanted effects.
Interventions
- DRUG Placebo
- DRUG Avenciguat (BI 685509)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 214 participants |
| Start Date | 2022-12-13 |
| Est. Completion | 2026-01-30 |
| Phase | Phase 2 |
What the finished NCT05559580 record still lists
NCT05559580 is an interventional study that assigns participants to a tested intervention. The registered 214 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05559580 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05559580 about?
NCT05559580 is a clinical study titled "A Study in People With Systemic Sclerosis to Test Whether Avenciguat (BI 685509) Has an Effect on Lung Function and Other Systemic Sclerosis Symptoms". This study is open to adults aged 18 and older or above legal age who have systemic sclerosis. People can participate if they have a specific subtype called diffuse cutaneous systemic sclerosis. People with another subtype called limited cutaneous systemic sclerosis can also participate if they are ...
What is the current status of trial NCT05559580?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 214 participants. The study started on 2022-12-13. Estimated completion is 2026-01-30.
What interventions are being tested in trial NCT05559580?
The interventions under investigation include: Placebo (DRUG), Avenciguat (BI 685509) (DRUG).
Who is sponsoring clinical trial NCT05559580?
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 NCT05559580's enrollment target sits among peer trials
214 290th of 2000 higher than 1,711 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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