107 Participants Needed

Namilumab for Chronic Pulmonary Sarcoidosis

(RESOLVE-Lung Trial)

Recruiting at 46 trial locations
LS
GB
RR
Overseen ByRayne Rodgers
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Kinevant Sciences GmbH
Must be taking: OCS, ISTs
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This trial tests namilumab, an injectable medication, on study participants. Namilumab works with the immune system to manage symptoms or treat a disease.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants who are treatment naive (not currently on treatment) are excluded, which suggests that continuing some medications might be allowed. It's best to discuss your specific medications with the study team.

What data supports the effectiveness of the drug Namilumab for treating chronic pulmonary sarcoidosis?

Namilumab has shown safety and effectiveness in treating rheumatoid arthritis, a condition involving inflammation, by targeting GM-CSF, a protein involved in immune responses. While not directly tested for sarcoidosis, similar drugs like infliximab have been effective in treating sarcoidosis, suggesting potential for Namilumab.12345

How is the drug namilumab different from other treatments for chronic pulmonary sarcoidosis?

Namilumab is unique because it is a monoclonal antibody that targets granulocyte-macrophage colony-stimulating factor (GM-CSF), which is different from traditional treatments like steroids. This approach may offer a new way to manage inflammation in sarcoidosis without relying on steroids.12678

Research Team

TR

Ted Reiss, MD

Principal Investigator

Kinevant Sciences

Eligibility Criteria

Adults over 18 with chronic pulmonary sarcoidosis, a BMI under 40, and difficulty breathing can join this trial. They must have completed their primary COVID-19 vaccination series at least two weeks before joining and have a history of sarcoidosis confirmed by medical records and tests. Pregnant or breastfeeding women, those with severe lung fibrosis or recent serious respiratory illness, high blood pressure extremes, other major diseases, or who are treatment naive cannot participate.

Inclusion Criteria

I have sarcoidosis with breathing difficulty and worsening symptoms or a reaction to reduced medication.
I completed my initial COVID-19 vaccination series over 2 weeks ago.
I have a confirmed sarcoidosis diagnosis for 6 months or more.
See 5 more

Exclusion Criteria

Participation in another interventional clinical trial (IP/Device) within 6 months prior to Screening, during screening and throughout the duration of the study
My lung scan shows I have significant scarring.
I am not pregnant, breastfeeding, nor plan to be during the study.
See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Double-blind Treatment

Participants receive namilumab or placebo subcutaneously every 4 weeks for 26 weeks

26 weeks
6 visits (in-person)

Open-label Extension

Participants may continue to receive namilumab for an additional 28 weeks

28 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Namilumab
Trial OverviewThe study is testing the effectiveness of Namilumab against a placebo in treating chronic pulmonary sarcoidosis. Participants will be randomly assigned to receive either Namilumab or a placebo without knowing which one they're getting (double-blind). After the main phase, there's an open-label extension where everyone may receive Namilumab.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment Arm 1Experimental Treatment1 Intervention
Namilumab
Group II: Treatment Arm 2Placebo Group1 Intervention
Placebo

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kinevant Sciences GmbH

Lead Sponsor

Trials
4
Recruited
370+

Findings from Research

Namilumab, a monoclonal antibody targeting GM-CSF, showed significant efficacy in reducing disease activity in rheumatoid arthritis patients who did not respond adequately to methotrexate or TNF inhibitors, with a notable improvement in the Disease Activity Score (DAS28-CRP) at week 12.
The treatment was well-tolerated, with no serious infections reported, although one serious adverse event (myocardial infarction) occurred in the highest dose group; overall, the safety profile was acceptable over the 12-week study period.
Efficacy and safety of namilumab, a human monoclonal antibody against granulocyte-macrophage colony-stimulating factor (GM-CSF) ligand in patients with rheumatoid arthritis (RA) with either an inadequate response to background methotrexate therapy or an inadequate response or intolerance to an anti-TNF (tumour necrosis factor) biologic therapy: a randomized, controlled trial.Taylor, PC., Saurigny, D., Vencovsky, J., et al.[2020]
The review highlights that treatment options for pulmonary sarcoidosis have expanded significantly over the past decade, including traditional glucocorticoids and newer biological agents like infliximab and adalimumab.
While there is no standardized method to assess treatment response, improvements in pulmonary function, chest imaging, and the ability to reduce steroid use are key indicators of effective treatment for pulmonary sarcoidosis.
Established and experimental medical therapy of pulmonary sarcoidosis.Baughman, RP., Nunes, H., Sweiss, NJ., et al.[2018]
In a proof-of-concept study involving 5 patients with corticosteroid-dependent pulmonary sarcoidosis, 60% (3 out of 5) were able to reduce their corticosteroid dosage by at least 50% after 16 weeks of treatment with tofacitinib, a Janus kinase inhibitor.
The patients who successfully tapered their corticosteroids also experienced improved respiratory symptoms and stable lung function, suggesting that JAK-inhibitors could be a promising alternative therapy for managing pulmonary sarcoidosis.
Tofacitinib as a Steroid-Sparing Therapy in Pulmonary Sarcoidosis, an Open-Label Prospective Proof-of-Concept Study.Friedman, MA., Le, B., Stevens, J., et al.[2021]

References

Randomized, double-blind, placebo-controlled, phase I study of the safety and pharmacokinetics of namilumab in healthy Japanese and Caucasian men . [2022]
Efficacy and safety of namilumab, a human monoclonal antibody against granulocyte-macrophage colony-stimulating factor (GM-CSF) ligand in patients with rheumatoid arthritis (RA) with either an inadequate response to background methotrexate therapy or an inadequate response or intolerance to an anti-TNF (tumour necrosis factor) biologic therapy: a randomized, controlled trial. [2020]
The use of infliximab in cutaneous sarcoidosis. [2015]
Established and experimental medical therapy of pulmonary sarcoidosis. [2018]
A double-blinded, randomized, placebo-controlled trial of infliximab in subjects with active pulmonary sarcoidosis. [2016]
A double-blind, placebo-controlled, randomized withdrawal trial of sarilumab for the treatment of glucocorticoid-dependent sarcoidosis. [2023]
Tofacitinib as a Steroid-Sparing Therapy in Pulmonary Sarcoidosis, an Open-Label Prospective Proof-of-Concept Study. [2021]
Phase 1b randomized, double-blind study of namilumab, an anti-granulocyte macrophage colony-stimulating factor monoclonal antibody, in mild-to-moderate rheumatoid arthritis. [2019]