BridgeMD
A randomized, double-blind, parallel group, placebo-controlled multicenter study to evaluate efficacy, safety and tolerability of ianalumab in participants with diffuse cutaneous systemic sclerosis
EU CTIS ID: 2024-511933-36-00
What this study is testing
To demonstrate the superiority of ianalumab, compared to placebo, in achieving 3/5 Revised Composite Response Index in Systemic Sclerosis 25 (rCRISS25) response at Week 52
- 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
- Male and female participants ≥ 18 and ≤ 70 years (at the time of the screening visit).
- Diagnosis of systemic sclerosis, as defined by the 2013 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) classification criteria for SSc (van den Hoogen et al 2013) and meet the dcSSc subset classification according to LeRoy (LeRoy et al 1988)
- Disease duration of ≤ 60 months (defined as time from the first non-Raynaud phenomenon manifestation, e.g., puffy hands, scleroderma, digital ulcers, arthralgia, dyspnea)
- mRSS units of ≥ 15 and ≤ 45 at the time of the screening visit
- Active disease that meets at least one of the following criteria at screening: • Disease duration of ≤ 18 months defined as time from the first non−Raynaud phenomenon manifestation • Increase in mRSS of ≥ 3 units compared with the most recent assessment performed within the previous 6 months • Invoed within the previous 6 months • Involvement of one new body area and an increase in mRSS of ≥ 2 units compared with the most recent assessment performlvement of two new body areas within the previous 6 months • Elevated acute phase reactants (ESR) ≥ 30 mm/hr or high-sensitivity C-reactive protein (hsCRP) ≥ 6 mg/L) • Presence of SSc-interstitial lung disease (ILD) and ATA autoantibody positivity • Modified EUSTAR disease activity index (mDAI) ≥ 2.5
- Participant must be positive for at least one of the following autoantibodies: • anti-topoisomerase I (ATA) (also known as anti-SCL-70) • anti-RNA polymerase III (anti-RNAP3) • anti-nuclear antibody (ANA) (≥ 1:80) Participants who are positive only for ANA (while being negative for both ATA /anti-RNAP3) will be limited to 30% of the overall randomized study population.
You likely can't join if
- Rheumatic disease other than dcSSc, including limited cutaneous disease (lcSSc) or sine scleroderma at the screening visit. Secondary Sjogren's disease and scleroderma myopathy are not exclusionary.
- Participants treated with cyclophosphamide within 12 weeks prior to Baseline.
- Prior use of a B-cell depleting therapy other than ianalumab (e.g., rituximab, other anti-CD20 mAb, anti-CD22 mAb, or anti-CD52 mAb) administered within 36 weeks prior to randomization, or as long as B cell count is less than the lower limit of normal or baseline value prior to receipt of B cell-depleting therapy (whichever is lower)
- Treatment with biologic agents, such as intravenous immunoglobulin or monoclonal antibodies, including marketed drugs, within 12 weeks or 5 half-lives (whichever is longer) prior to baseline visit, unless explicitly allowed in inclusion criteria
- Treatment with any investigational agent within ≤ 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of the baseline visit
- Use of anti-fibrotic agents including colchicine, D-penicillamine, pirfenidone, or tyrosine kinase inhibitors (e.g., nintedanib, nilotinib, imatinib, dasatinib) in the 4 weeks prior to baseline visit. Patients with SSc-ILD requiring antifibrotics for management of ILD during the study, as per investigator judgement, should be excluded
See the full eligibility criteria
Who can join
- Male and female participants ≥ 18 and ≤ 70 years (at the time of the screening visit).
- Diagnosis of systemic sclerosis, as defined by the 2013 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) classification criteria for SSc (van den Hoogen et al 2013) and meet the dcSSc subset classification according to LeRoy (LeRoy et al 1988)
- Disease duration of ≤ 60 months (defined as time from the first non-Raynaud phenomenon manifestation, e.g., puffy hands, scleroderma, digital ulcers, arthralgia, dyspnea)
- mRSS units of ≥ 15 and ≤ 45 at the time of the screening visit
- Active disease that meets at least one of the following criteria at screening: • Disease duration of ≤ 18 months defined as time from the first non−Raynaud phenomenon manifestation • Increase in mRSS of ≥ 3 units compared with the most recent assessment performed within the previous 6 months • Invoed within the previous 6 months • Involvement of one new body area and an increase in mRSS of ≥ 2 units compared with the most recent assessment performlvement of two new body areas within the previous 6 months • Elevated acute phase reactants (ESR) ≥ 30 mm/hr or high-sensitivity C-reactive protein (hsCRP) ≥ 6 mg/L) • Presence of SSc-interstitial lung disease (ILD) and ATA autoantibody positivity • Modified EUSTAR disease activity index (mDAI) ≥ 2.5
- Participant must be positive for at least one of the following autoantibodies: • anti-topoisomerase I (ATA) (also known as anti-SCL-70) • anti-RNA polymerase III (anti-RNAP3) • anti-nuclear antibody (ANA) (≥ 1:80) Participants who are positive only for ANA (while being negative for both ATA /anti-RNAP3) will be limited to 30% of the overall randomized study population.
What rules you out
- Rheumatic disease other than dcSSc, including limited cutaneous disease (lcSSc) or sine scleroderma at the screening visit. Secondary Sjogren's disease and scleroderma myopathy are not exclusionary.
- Participants treated with cyclophosphamide within 12 weeks prior to Baseline.
- Prior use of a B-cell depleting therapy other than ianalumab (e.g., rituximab, other anti-CD20 mAb, anti-CD22 mAb, or anti-CD52 mAb) administered within 36 weeks prior to randomization, or as long as B cell count is less than the lower limit of normal or baseline value prior to receipt of B cell-depleting therapy (whichever is lower)
- Treatment with biologic agents, such as intravenous immunoglobulin or monoclonal antibodies, including marketed drugs, within 12 weeks or 5 half-lives (whichever is longer) prior to baseline visit, unless explicitly allowed in inclusion criteria
- Treatment with any investigational agent within ≤ 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of the baseline visit
- Use of anti-fibrotic agents including colchicine, D-penicillamine, pirfenidone, or tyrosine kinase inhibitors (e.g., nintedanib, nilotinib, imatinib, dasatinib) in the 4 weeks prior to baseline visit. Patients with SSc-ILD requiring antifibrotics for management of ILD during the study, as per investigator judgement, should be excluded
- Previous treatment with chlorambucil, bone marrow transplantation or total lymphoid irradiation.
- Positive anti-centromere antibody (ACA+) without positive ATA or anti-RNAP3 autoantibody result at the screening visit
- Previous improvement (decrease) in mRSS > 10 units
- Pulmonary disease with FVC ≤ 50% of predicted or diffusing capacity of the lung for carbon monoxide (DLCO, corrected for hemoglobin) ≤ 40% of predicted at the screening visit
- WHO Functional Class 3 or higher assessment for pulmonary arterial hypertension (PAH, as defined on right heart catheterization), receiving IV therapy for PAH or evidence of other moderately severe pulmonary disease
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- China
- Korea, Republic of
- Vietnam
- Mexico
- South Africa
- United States
- Malaysia
- Thailand
- Brazil
- India
- Argentina
- Turkey
- Colombia
- Japan
- Taiwan
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, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; China; Korea, Republic of; Vietnam; Mexico; South Africa and 10 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.