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Platform Clinical Study for Conquering Scleroderma

ConditionsInterstitial Lung Disease Due to Systemic DiseaseScleroderma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorScleroderma Research Foundation, Inc.

About this trial

The goal of this clinical trial is to test efficacy of different investigational products (IPs) compared with placebo on the change from baseline to the end of the treatment period at Week 52 in lung capacity in participants with Interstitial Lung Disease Secondary to Systemic Sclerosis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female 18+ years of age at the time of signed informed consent;

SSc classification as defined by the 2013 American College of Rheumatology/European League Against Rheumatism criteria. Participants with diffuse, limited or sine cutaneous skin involvement are eligible

Onset of SSc (defined by first non-Raynaud's symptom) 7 years or less prior to the Screening Visit;

A Modified Rodnan skin score (mRSS) less than 40

Disqualifiers

Presence of clinically significant pulmonary abnormalities inconsistent with ILD on HRCT (e.g., scarring due to previous active tuberculosis [TB], sarcoidosis, lung mass, or other findings unrelated to SSc-ILD, as determined by a local radiologist/Investigator);

Presence of infected ulcers or active gangrene at the Screening Visit;

History of scleroderma renal crisis within 6 months prior to the Screening Visit;

Forced expiratory volume in 1 second/FVC <0.65 (pre-bronchodilator) at the Screening Visit

Trial design

Design model

Parallel

Treatments tested in this trial

  • Amlitelimab

    Drug

    IP will be administered subcutaneously by the Investigator or designee as follows: * Amlitelimab or * Matching placebo

  • BI 1015550 (Nerandomilast)

    Drug

    Study participants will take the active investigational product BI 1015550 (Nerandomilast) or matching placebo provided as film-coated tablets, administered orally BID.

  • Placebo

    Drug

    see Experimental Arm intervention description

Treatment groups

400 Participants
are divided into 4 treatment groups
Group A: AmlitelimabExperimental treatment 1 intervention
Group B: Amlitelimab matching placeboPlacebo comparator 1 intervention
Group C: BI 1015550 (Nerandomilast)Experimental treatment 1 intervention
Group D: BI 1015550 (Nerandomilast) matching placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The change in forced vital capacity (FVC, in mL).

Time frame
from baseline to the end of the treatment period at Week 52

Secondary outcomes

1

The percent change in high-resolution computed tomography (HRCT) quantitative interstitial lung disease - whole lung (QILD-WL);

Lung involvement as measured by high-resolution computed tomography (HRCT) assessed by quantitative interstitial lung disease - whole lung (QILD-WL)

Time frame
from baseline to the end of the treatment period at Week 52
2

The change in Functional Assessment of Chronic Illness Therapy (FACIT)-Dyspnea score.

Dyspnea (severity and functional limitations) are measured by the Functional Assessment of Chronic Illness Therapy (FACIT) - Dyspnea score. Dyspnea score range 0-4, total score 0-30 (higher score = worse outcome).

Time frame
from baseline to the end of the treatment period at Week 52
3

The proportion of study participants with an improvement in the revised CRISS score, in study participants with diffuse cutaneous SSc and baseline mRRS ≥10.

Time frame
baseline, Week 52

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Scleroderma Research Foundation, Inc.

Lead sponsor

Sanofi

Collaborator

Boehringer Ingelheim

Collaborator

Source ClinicalTrials.gov
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