NCT07497087 A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis
| NCT ID | NCT07497087 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Boehringer Ingelheim |
| Condition | Systemic Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 448 participants |
| Start Date | 2026-07-27 |
| Primary Completion | 2030-02-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 448 participants in total. It began in 2026-07-27 with a primary completion date of 2030-02-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion criteria: 1. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. 2. Patients must be at least 18 years of age and fulfil the 2013 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) criteria for SSc. 3. Patients must be diagnosed with limited cutaneous SSc (lcSSc) or diffuse cutaneous SSc (dcSSc), as defined by LeRoy et al. (1988). 4. Disease onset (defined by first non-RP \[Raynaud's phenomenon\] symptom) must be within 7 years of Visit 1. 5. Trial participants with dcSSc must have evidence of active disease during screening. 6. Trial participants with lcSSc must have evidence of active disease during screening. LcSSc patients must be anti-centromere antibody (ACA) negative. 7. FVC % predicted ≥45% at Visit 1. 8. Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) % predicted ≥25% corrected for haemoglobin (Hb) at Visit 1. 9. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control. 10. Patients may be either untreated or on stable treatment with permitted immunosuppressive/immunomodulatory agents and/or nintedanib. All treatments must remain stable prior to Visit 2 and during the screening period Exclusion criteria: 1. Active, unstable, or uncontrolled vasculitis within 8 weeks prior to Visit 1 or during the screening period. 2. Any suicidal behaviour in the past 2 years. 3. Any suicidal ideation of type 4 or 5 on the C-SSRS in the past 3 months. Further exclusion criteria apply.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07497087 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Systemic Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07497087 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 448 participants.
Is NCT07497087 currently recruiting?
Yes, NCT07497087 is actively recruiting participants. Contact the research team at clintriage.rdg@boehringer-ingelheim.com for enrollment information.
Where is the NCT07497087 trial being conducted?
This trial is being conducted at Birmingham, United States, Phoenix, United States, Scottsdale, United States, Los Angeles, United States and 11 additional locations.
Who is sponsoring the NCT07497087 clinical trial?
NCT07497087 is sponsored by Boehringer Ingelheim. The trial plans to enroll 448 participants.