BridgeMD
A study in people with systemic sclerosis to test whether BI 685509 has an effect on lung function and other systemic sclerosis symptoms
EU CTIS ID: 2022-500332-11-00
What this study is testing
The primary objective is to assess superiority of BI 685509 over placebo based on the mean difference in annual rate of decline in FVC over 48 weeks. The treatment effect of primary interest will be based on all randomised patients including the effects of any changes of treatment, i.e., a treatment policy strategy will be used.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
- Male or female patients aged ≥18 years at time of consent (or above legal age, e.g. UK ≥16 years).
- Patients must fulfil the 2013 ACR/EULAR classification criteria for SSc.
- Patients must be diagnosed with limited or diffuse cutaneous SSc as defined by LeRoy et al. Patients diagnosed with limited cutaneous SSc may be included if they are anti Scl-70 antibody positive.
- Diffuse cutaneous SSc disease onset (defined by first non-RP symptom) must be within 7 years of Visit 1. Limited cutaneous SSc onset must be within 2 years of Visit 1
- Evidence of active disease, defined as having at least one of the following: - New onset of SSc within the last 2 years of Visit 1 OR - New skin involvement or worsening of two new body areas within 6 months of Visit 1 (out of the 17 body areas defined by mRSS assessment, documented in clinical files) OR - New involvement or worsening of one new body area if either chest or abdomen within 6 months of Visit 1 OR - Worsening of skin thickening (e.g. ≥2 mRSS points) within 6 months of Visit 1 OR - ≥1 tendon friction rub.
You likely can't join if
- Any known form of pulmonary hypertension.
- Pulmonary disease with FVC <50% of predicted at screening.
- Other autoimmune connective tissue diseases, except for fibromyalgia, scleroderma-associated myopathy and secondary Sjogren syndrome.
- Diffusing capacity for carbon monoxide (DLCO) (haemoglobin corrected) <40% of predicted at screening.
- Any history of scleroderma renal crisis within the last 6 months.
- Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 (CKD-EPI formula) or on dialysis at screening.
See the full eligibility criteria
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
- Male or female patients aged ≥18 years at time of consent (or above legal age, e.g. UK ≥16 years).
- Patients must fulfil the 2013 ACR/EULAR classification criteria for SSc.
- Patients must be diagnosed with limited or diffuse cutaneous SSc as defined by LeRoy et al. Patients diagnosed with limited cutaneous SSc may be included if they are anti Scl-70 antibody positive.
- Diffuse cutaneous SSc disease onset (defined by first non-RP symptom) must be within 7 years of Visit 1. Limited cutaneous SSc onset must be within 2 years of Visit 1
- Evidence of active disease, defined as having at least one of the following: - New onset of SSc within the last 2 years of Visit 1 OR - New skin involvement or worsening of two new body areas within 6 months of Visit 1 (out of the 17 body areas defined by mRSS assessment, documented in clinical files) OR - New involvement or worsening of one new body area if either chest or abdomen within 6 months of Visit 1 OR - Worsening of skin thickening (e.g. ≥2 mRSS points) within 6 months of Visit 1 OR - ≥1 tendon friction rub.
- Elevated biomarkers on Visit 1 (screening) defined as at least one of the following: - CRP ≥6 mg/L (≥0.6 mg/dL), OR - Erythrocyte sedimentation rate (ESR) ≥28 mm/h, OR - KL-6 ≥1000 U/mL. --> If none of the three criteria are met or should not be available, the patient can be entered if the mDAI is ≥ 2.5.
- Evidence of significant vasculopathy, defined as: - Active DU(s) on Visit 1 OR - Documented history of DU(s), OR - Previous treatment of RP with prostacyclin analogues or ≥ 1 other medications, including calcium channel blockers, nitrates, NO donors in any form, including topical; phosphodiesterase 5 (PDE5) inhibitors (e.g., sildenafil, tadalafil, vardenafil); nonspecific PDE5 inhibitors (theophylline, dipyridamole) OR - RP with elevated CRP ≥6 mg/L --> If none of the four criteria above are met, the patient can be entered if the diagnosis of ILD has been confirmed
- Further inclusion criteria apply.
- Any known form of pulmonary hypertension.
- Pulmonary disease with FVC <50% of predicted at screening.
- Other autoimmune connective tissue diseases, except for fibromyalgia, scleroderma-associated myopathy and secondary Sjogren syndrome.
- Diffusing capacity for carbon monoxide (DLCO) (haemoglobin corrected) <40% of predicted at screening.
- Any history of scleroderma renal crisis within the last 6 months.
- Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 (CKD-EPI formula) or on dialysis at screening.
- Cirrhosis of any Child-Pugh class (A, B or C)
- Cholestasis at present, or ALP > 4 x ULN, or ALP > 2 x ULN and GGT > 3 x ULN at screening.
- Further criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- Israel
- Korea, Republic of
- China
- Thailand
- Malaysia
- Taiwan
- Switzerland
- United Kingdom
- Mexico
- Australia
- Brazil
- India
- United States
- Turkey
- Singapore
- Argentina
- Canada
- New Zealand
- Philippines
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; Israel; Korea, Republic of; China; Thailand; Malaysia and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.