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Monoclonal Antibodies

Amlitelimab for Interstitial Lung Disease (CONQUEST Trial)

Phase 2

Waitlist Available

Research Sponsored by Scleroderma Research Foundation, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Modified Rodnan skin score (mRSS) of 10 to 35, inclusive, in participants with diffuse cutaneous SSc

SSc classification as defined by the 2013 American College of Rheumatology/European League Against Rheumatism criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 52

Awards & highlights

CONQUEST Trial Summary

This trial aims to test how well different investigational products work compared to a placebo in improving lung capacity in people with Interstitial Lung Disease caused by Systemic Sclerosis.

Who is the study for?

This trial is for individuals with Interstitial Lung Disease due to Systemic Sclerosis, a type of scleroderma affecting the lungs. Participants should have measurable lung disease at the start and be able to perform certain lung function tests.Check my eligibility

What is being tested?

The study is testing two potential treatments: Amlitelimab and BI 1015550, against a placebo. The main goal is to see if these treatments can improve lung capacity after one year compared to no treatment (placebo).See study design

What are the potential side effects?

Potential side effects are not specified here but typically could include reactions at the injection site, flu-like symptoms, gastrointestinal issues, or changes in blood pressure or liver enzymes.

CONQUEST Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My skin thickness score is between 10 and 35.

Select...

My condition meets the 2013 criteria for systemic sclerosis.

Select...

I have lung scarring seen on a recent detailed lung scan.

CONQUEST Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

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

The proportion of study participants with an improvement in the revised CRISS score, in study participants with diffuse cutaneous SSc.

CONQUEST Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: BI 1015550Experimental Treatment1 Intervention

Group II: AmlitelimabExperimental Treatment1 Intervention

Group III: BI 1015550 matching placeboPlacebo Group1 Intervention

Group IV: Amlitelimab matching placeboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BI 1015550

2023

Completed Phase 2

~470

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

SanofiIndustry Sponsor

2,164 Previous Clinical Trials

3,514,580 Total Patients Enrolled

Boehringer IngelheimIndustry Sponsor

2,508 Previous Clinical Trials

11,340,551 Total Patients Enrolled

Scleroderma Research Foundation, Inc.Lead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for patients in this ongoing clinical trial?

"According to the information provided by clinicaltrials.gov, this particular trial is not actively seeking patients at present. The trial was first posted on April 1st, 2024 and underwent its most recent update on December 22nd, 2023. However, it's worth noting that there are currently a total of 357 ongoing trials actively recruiting participants."

Answered by AI

In how many diverse venues is this experimental examination currently being conducted?

"At present, there are 27 sites actively enrolling patients for this trial. These sites are situated in various locations such as Los Angeles, Ann Arbor, New york, and several others. To minimize travel requirements, it is advisable to select the site closest to your location if you decide to participate."

Answered by AI

Has amlitelimab received the official sanction from the FDA?

"Based on the nature of this Phase 2 trial, our team at Power assesses the safety of amlitelimab to be moderate with a score of 2. While there is preliminary data indicating its safety, no evidence regarding efficacy has been established yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Platform Clinical Study for Conquering Scleroderma

2024. "Platform Clinical Study for Conquering Scleroderma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06195072.

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