PRA023 for Systemic Sclerosis-Associated ILD

(ATHENA-SSc-ILD Trial)

Recruiting in Palo Alto (17 mi)

+154 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Must be taking: Nintedanib, MMF, Methotrexate, Azathioprine

Disqualifiers: Pulmonary hypertension, Infections, Smoking, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that if you are on certain medications like nintedanib, mycophenolate mofetil, methotrexate, azathioprine, or corticosteroids, you must be on a stable dose. This suggests you may continue these medications if they are stable.

What data supports the effectiveness of the drug PRA023 for treating systemic sclerosis-associated interstitial lung disease?

Research on similar drugs like tocilizumab, which is used for systemic sclerosis, shows it can help prevent lung fibrosis progression. Additionally, nintedanib, another drug for lung fibrosis, has been effective in reducing lung damage in conditions similar to systemic sclerosis. ^{1 2 3 4 5}

What makes the drug PRA023 unique for treating systemic sclerosis-associated ILD?

PRA023 (Tulisokibart, MK-7240) is unique because it is a novel treatment being explored specifically for systemic sclerosis-associated interstitial lung disease (ILD), a condition with no universally accepted disease-modifying therapy. Unlike other treatments, PRA023 may offer a new approach by targeting specific pathways involved in the disease, although detailed information about its mechanism of action is not provided in the available research. ^{4 6 7 8 9}

Research Team

Prometheus Biosciences

Principal Investigator

Clinical Trials Call Center

Eligibility Criteria

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.

Inclusion Criteria

I was diagnosed with systemic sclerosis less than 5 years ago.

Diffusing capacity of lung for carbon monoxide (DLCO)≥ 45% of predicted normal

FVC ≥ 45% of predicted normal

Exclusion Criteria

Is a current smoker or smoking within 6 months of screening

Meets the protocol criteria for important laboratory exclusion criteria

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

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Tulisokibart or placebo via IV infusion

50 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• PRA023 (Monoclonal Antibodies)

Trial Overview 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.

Participant Groups

Group I: Tulisokibart Experimental Treatment 2 Interventions

Tulisokibart IV administered by IV infusion

Group II: Placebo Placebo Group 2 Interventions

Placebo administered by IV infusion

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

6

Recruited

600+

Prometheus Biosciences, Inc.

Lead Sponsor

Trials

6

Recruited

600+

Findings from Research

A 69-year-old man with rheumatoid arthritis-associated interstitial lung disease (RA-ILD) showed significant improvement in symptoms and lung function after switching to upadacitinib, a Janus kinase inhibitor, after failing multiple other treatments.

This case suggests that JAK inhibitors may be a promising option for patients with refractory RA-ILD, highlighting the need for further research into their efficacy in this specific condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful Treatment of a Patient with Drug-Refractory Rheumatoid Arthritis-Associated Interstitial Lung Disease with Upadacitinib: A Case Report. Nishii, Y., Okamoto, M., Zaizen, Y., et al.[2023]

In a real-life study involving 93 patients with systemic sclerosis (SSc) treated with tocilizumab and 3180 patients receiving standard care, tocilizumab showed trends favoring improvements in skin and lung fibrosis, although these were not statistically significant.

The safety profile of tocilizumab was consistent with previous reports, suggesting it is a relatively safe option for SSc patients, and the results indicate potential effectiveness that warrants further investigation in larger populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of tocilizumab in patients with systemic sclerosis: a propensity score matched controlled observational study of the EUSTAR cohort. Kuster, S., Jordan, S., Elhai, M., et al.[2022]

Biologic therapies like rituximab have shown significant improvements in lung function and skin disease in patients with systemic sclerosis, suggesting they may be effective treatment options despite the lack of universally accepted therapies.

While tocilizumab and abatacept have shown some potential benefits, their results have not consistently reached statistical significance, indicating that more research is needed to establish their efficacy in treating systemic sclerosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is biological therapy in systemic sclerosis the answer? Misra, DP., Ahmed, S., Agarwal, V.[2021]

Biologic therapies targeting immune system components, such as cytokines and immune cells, show promise as alternative treatments for systemic sclerosis (SSc), a complex autoimmune disorder characterized by collagen deposition and microvascular changes.

Preliminary data suggest that these targeted immunotherapies may be effective and safe in treating SSc, based on results from both animal studies and human trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted immunotherapies in systemic sclerosis. Avouac, J., Allanore, Y.[2017]

In a study involving 20 Japanese patients with systemic sclerosis, tocilizumab showed a trend towards improved lung function compared to placebo, with a mean change in forced vital capacity of 3.3% for tocilizumab versus -3.8% for placebo during the double-blind period.

The safety profile of tocilizumab was favorable, with lower rates of serious adverse events compared to placebo, particularly in the open-label extension phase where no serious events were reported for continuous tocilizumab.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tocilizumab in Japanese patients with systemic sclerosis and associated interstitial lung disease: A subgroup analysis of a global, randomised, controlled Phase 3 trial. Kuwana, M., Takehara, K., Tanaka, Y., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Successful Treatment of a Patient with Drug-Refractory Rheumatoid Arthritis-Associated Interstitial Lung Disease with Upadacitinib: A Case Report. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of tocilizumab in patients with systemic sclerosis: a propensity score matched controlled observational study of the EUSTAR cohort. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Nintedanib reduces pulmonary fibrosis in a model of rheumatoid arthritis-associated interstitial lung disease. [2022]

4. England pubmed.ncbi.nlm.nih.gov

A randomised, double-blind, placebo-controlled, 24-week, phase II, proof-of-concept study of romilkimab (SAR156597) in early diffuse cutaneous systemic sclerosis. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Tocilizumab in systemic sclerosis: a randomised, double-blind, placebo-controlled, phase 3 trial. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

Is biological therapy in systemic sclerosis the answer? [2021]

7. Italy pubmed.ncbi.nlm.nih.gov

Targeted immunotherapies in systemic sclerosis. [2017]

8. United States pubmed.ncbi.nlm.nih.gov

Therapeutic Approaches to Systemic Sclerosis: Recent Approvals and Future Candidate Therapies. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tocilizumab in Japanese patients with systemic sclerosis and associated interstitial lung disease: A subgroup analysis of a global, randomised, controlled Phase 3 trial. [2023]