Namilumab for Chronic Pulmonary Sarcoidosis

(RESOLVE-Lung Trial)

No longer recruiting at 52 trial locations

Overseen By Rayne Rodgers

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Kinevant Sciences GmbH

Must be taking: OCS, ISTs

Disqualifiers: Respiratory illness, Fibrosis, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how well the drug Namilumab works for people with chronic pulmonary sarcoidosis, a condition where clusters of inflammatory cells grow in the lungs and can make breathing difficult. The study compares the effects of Namilumab to a placebo (a substance with no active drug) to determine if it alleviates symptoms. Suitable participants have had sarcoidosis for at least six months and experience breathing difficulties that affect daily life. Eligible participants will receive either Namilumab or a placebo, helping researchers understand the drug's effectiveness. As a Phase 2 trial, this research measures how well the treatment works in an initial, smaller group, offering participants a chance to contribute to important findings.

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.

Is there any evidence suggesting that Namilumab is likely to be safe for humans?

Research has shown that namilumab has undergone safety testing in studies involving patients with long-term lung conditions. Early results suggest that namilumab, a monoclonal antibody, is generally safe. Most patients did not experience serious side effects. Some individuals might have mild reactions, such as headaches or fatigue, which are common with many treatments. Safety remains a primary focus in these studies, so researchers closely monitor any side effects. Prospective participants should consult a healthcare provider about any concerns before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Namilumab is unique because it targets GM-CSF, a protein involved in inflammation, which could offer a novel approach to treating chronic pulmonary sarcoidosis. Most current treatments, like corticosteroids and immunosuppressants, work by broadly dampening the immune response, but they can have significant side effects. Namilumab, by specifically targeting GM-CSF, aims to reduce inflammation more precisely, potentially minimizing side effects and improving quality of life for patients. Researchers are excited because this targeted mechanism could provide a more effective and safer alternative to existing therapies.

What evidence suggests that Namilumab might be an effective treatment for chronic pulmonary sarcoidosis?

Research shows that namilumab might help treat chronic lung sarcoidosis. In a small study with five patients who relied on corticosteroids for their sarcoidosis, 60% reduced their use of these drugs while taking namilumab. However, the larger RESOLVE-Lung study did not achieve its main goal of preventing the condition from worsening significantly. This trial will compare namilumab to a placebo to further evaluate its effectiveness. While some hope exists, the effectiveness of namilumab for this condition remains uncertain. More research is needed to fully understand its potential benefits. ^{1 2 3 6 7}

Who Is on the Research Team?

Ted Reiss, MD

Principal Investigator

Kinevant Sciences

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Namilumab

Trial Overview The 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.

How Is the Trial Designed?

Group I: Treatment Arm 1 Experimental Treatment 1 Intervention

Namilumab

Group II: Treatment Arm 2 Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

Kinevant Sciences GmbH

Lead Sponsor

Trials

4

Recruited

370+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1551714425002721

Design of RESOLVE Lung, a multinational Phase 2 ... The objective of this trial is to evaluate the efficacy and safety of namilumab in patients with active CPS. The primary endpoint is the ...

2. investor.roivant.com investor.roivant.com/news-releases/news-release-details/roivant-announces-topline-results-phase-2-resolve-lung-study

Roivant Announces Topline Results from Phase 2 RESOLVE ... The Phase 2 RESOLVE-Lung study (NCT05314517) evaluated the efficacy and safety of namilumab, an investigational anti-GM-CSF monoclonal antibody administered ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05314517

NCT05314517 | A Study to Assess the Efficacy and Safety ... This is a randomized, double-blind, placebo-controlled study with an OLE. Participants will be randomized to receive namilumab or placebo in the 26-week Double ...

4. withpower.com withpower.com/trial/phase-2-sarcoidosis-3-2022-4ed7f

Namilumab for Chronic Pulmonary Sarcoidosis · Info for ... 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 ...

5. synapse.patsnap.com synapse.patsnap.com/article/roivant-reports-phase-2-resolve-lung-study-results-for-namilumab-in-chronic-pulmonary-sarcoidosis

Roivant Reports Phase 2 RESOLVE-Lung Study Results ... Unfortunately, namilumab failed to meet this primary endpoint. A Rescue Event was defined as a clinically significant worsening of sarcoidosis ...

6. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-effects-and-safety-of-namilumab-for-patients-with-chronic-lung-sarcoidosis/

Study on the Effects and Safety of Namilumab for Patients ... This clinical trial investigates the efficacy and safety of Namilumab, a monoclonal antibody, in treating patients with chronic lung ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10272527/

Biologic drugs in the treatment of chronic inflammatory ... Secondary outcomes include Namilumab safety and tolerability, quality of ... safety of namilumab in subjects with chronic pulmonary sarcoidosis (2023).