What side effects are associated with this type of intervention?

Common treatments for Systemic Sclerosis include immunosuppressants like methotrexate and mycophenolate mofetil, which can cause side effects such as nausea, liver toxicity, and increased risk of infections. Anti-fibrotic agents like nintedanib may lead to gastrointestinal issues, liver enzyme elevations, and weight loss. Anti-inflammatory agents such as corticosteroids are associated with side effects like weight gain, hypertension, osteoporosis, and increased susceptibility to infections. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

FDA-approved treatments for Systemic Sclerosis include immunosuppressive agents like mycophenolate mofetil and cyclophosphamide, which help manage interstitial lung disease associated with the condition. Nintedanib, an anti-fibrotic agent, has also been approved to slow the decline in lung function in patients with systemic sclerosis-associated interstitial lung disease. These treatments aim to modulate the immune response, reduce inflammation, and prevent fibrosis, similar to the mechanisms likely being studied with Tulisokibart.

What other types of research exist?

Promising novel alternatives to Tulisokibart for Systemic Sclerosis patients in 2024 include: 1) Nintedanib, an anti-fibrotic agent that has shown efficacy in slowing disease progression in SSc-ILD. 2) Pirfenidone, another anti-fibrotic agent with potential benefits in SSc-ILD. 3) Tocilizumab, an IL-6 receptor antagonist that has demonstrated efficacy in reducing skin thickening and stabilizing lung function in SSc patients. These alternatives have shown promise in clinical trials and may offer effective treatment options for SSc patients.

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Monoclonal Antibodies

PRA023 for Systemic Sclerosis-Associated ILD (ATHENA-SSc-ILD Trial)

Phase 2

Recruiting

Research Sponsored by Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Eligibility Criteria Checklist

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

Must have

Has diffuse cutaneous scleroderma

Has systemic sclerosis related interstitial lung disease confirmed by HRCT

Must not have

Has any active infections, a serious infection within the past 3 months, or chronic bacterial infection

Has current clinical diagnosis of another inflammatory connective tissue disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 50

Summary

This trial tests a new medication called tulisokibart on people with a lung disease called SSc-ILD. The goal is to see if it is safe and helps improve their condition.

Who is the study for?

This trial is for people with systemic sclerosis that started within the last 5 years and associated lung disease, who are not current smokers. They must have a certain level of lung function and be on stable medication doses. Participants need to use effective contraception and cannot join if they have other inflammatory diseases, serious recent infections, or significant heart or lung complications.

What is being tested?

The study tests PRA023's safety and effectiveness in treating systemic sclerosis-related lung disease compared to a placebo. A companion diagnostic tool is also used. The goal is to see if PRA023 can help manage this condition better than existing treatments.

What are the potential side effects?

While specific side effects for PRA023 aren't listed here, similar medications may cause immune system reactions, infusion-related discomforts, fatigue, digestive issues like nausea or diarrhea, skin reactions at injection sites, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have been diagnosed with diffuse cutaneous scleroderma.

Select...

I have lung disease related to systemic sclerosis confirmed by a special lung scan.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have any current infections, serious infections in the past 3 months, or chronic bacterial infections.

Select...

I have been diagnosed with another inflammatory connective tissue disease.

Select...

I have breathing issues due to blocked airways or high blood pressure in my lungs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 50

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 50

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 50 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline in the Annual Rate of Change in Forced Vital Capacity (FVC) at Week 50

Number of Participants who Discontinue due to an AE

Number of Participants who Experience a Serious Adverse Event (SAE)

+1 more

Secondary study objectives

Change from Baseline in FVC at Week 50

Change from Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 50

Change from Baseline in High-Resolution Computer Tomography (HRCT) Quantitative Interstitial Lung Disease - Whole Lung (QILD-WL) at Week 50

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TulisokibartExperimental Treatment2 Interventions

Tulisokibart IV administered by IV infusion

Group II: PlaceboPlacebo Group2 Interventions

Placebo administered by IV infusion

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Systemic Sclerosis (SSc) include immune modulators, anti-fibrotic agents, and anti-inflammatory agents. Immune modulators alter the immune system's activity to reduce the abnormal immune response in SSc. Anti-fibrotic agents aim to prevent or reduce fibrosis, the thickening and scarring of connective tissue. Anti-inflammatory agents reduce inflammation, helping to manage symptoms and prevent further tissue damage. These mechanisms are crucial for SSc patients as they target the underlying disease processes, potentially improving outcomes and quality of life.

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