What side effects are associated with this type of intervention?

Common treatments for sarcoidosis include glucocorticoids, methotrexate, azathioprine, leflunomide, mycophenolate mofetil, and TNF antagonists such as infliximab and adalimumab. Glucocorticoids can cause weight gain, hypertension, diabetes, osteoporosis, and increased risk of infections. Methotrexate may lead to liver toxicity, bone marrow suppression, and lung disease. Azathioprine and leflunomide can cause liver damage, bone marrow suppression, and gastrointestinal issues. Mycophenolate mofetil is associated with gastrointestinal disturbances and increased infection risk. TNF antagonists can increase the risk of infections, including tuberculosis, and may cause injection site reactions and autoimmune conditions.

What prior FDA approvals exist?

There are no specific FDA-approved drugs for the treatment of Sarcoidosis mentioned in the provided context. However, various immunosuppressive agents and biologics, such as methotrexate, mycophenolate mofetil, and tumor necrosis factor (TNF) inhibitors like infliximab and adalimumab, have been used off-label to manage refractory Sarcoidosis. These treatments aim to reduce inflammation and manage symptoms in patients who do not respond to initial therapies.

What other types of research exist?

Namilumab is a promising novel alternative for Sarcoidosis patients considering treatment in 2024. It is currently being evaluated in a randomized, double-blind, placebo-controlled study for its efficacy and safety in chronic pulmonary sarcoidosis.

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Monoclonal Antibodies

Namilumab for Chronic Pulmonary Sarcoidosis (RESOLVE-Lung Trial)

Phase 2

Waitlist Available

Research Sponsored by Kinevant Sciences GmbH

Eligibility Criteria Checklist

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

Must have

Evidence of sarcoidosis as indicated by: a) HRCT consistent with Pulmonary Sarcoidosis AND; b) Medical Research Council Dyspnea scale >1 (i.e., Grade 2 or more) AND; c) One or more of the following is present: i) Screening FDG-PET consistent with pulmonary sarcoidosis AND SUVmax ≥ 3; ii) Recent history of worsening sarcoidosis; iii) Recent history that tapering OCS and/or ISTs resulted in an increase of pulmonary disease

Greater than or equal to 6-month history of documented sarcoidosis including histological confirmation in the subject's medical records

Must not have

Greater than or equal to 20% fibrosis as indicated on HRCT-scan assessed by central read prior to randomization

Females who are pregnant or breastfeeding or intend to be during the course of the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 26

Summary

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

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects for participants could include reactions at the injection site, increased risk of infections due to immune system suppression by Namilumab, headaches, fatigue, and possible interference with liver function.

Eligibility Criteria

Inclusion Criteria

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

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I have sarcoidosis with breathing difficulty and worsening symptoms or a reaction to reduced medication.

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I have a confirmed sarcoidosis diagnosis for 6 months or more.

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I have had trouble breathing when moving around in the last 6 months.

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I am 18 years old or older.

Exclusion Criteria

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

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My lung scan shows I have significant scarring.

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I am not pregnant, breastfeeding, nor plan to be during the study.

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I have not received any treatment for my condition.

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I have a lung condition that stops me from doing a breathing test properly.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 26

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 26

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 26 for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Change in the Kings Sarcoidosis Questionnaire (KSQ) Lung domain score

Safety and Tolerability

Side effects data

From 2016 Phase 2 trial • 122 Patients • NCT02129777

Nasopharyngitis

Upper respiratory tract infection

100%

80%

60%

40%

20%

Study treatment Arm

Double-Blind Period: Namilumab 150 mg

Open-Label Period: Namilumab 150 mg

Follow-up Period: Placebo

Follow-up Period: Namilumab 20 mg

Follow-up: Namilumab 150 mg

Double-Blind Period: Placebo

Double-Blind Period: Namilumab 20 mg

Double-Blind Period: Namilumab 50 mg

Double-Blind Period: Namilumab 80 mg

Open-Label Period: Namilumab 80 mg

Follow-up Period: Namilumab 80 mg

Follow-up Period: Namilumab 50 mg

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment Arm 1Experimental Treatment1 Intervention

Namilumab

Group II: Treatment Arm 2Placebo Group1 Intervention

Placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Namilumab

2014

Completed Phase 2

~280

0 / 8Eligibility 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 Sarcoidosis work by reducing inflammation and modulating the immune response. Corticosteroids, such as prednisone, are often used to suppress the immune system and decrease inflammation. Immunosuppressive agents like methotrexate and azathioprine inhibit the proliferation of immune cells, thereby reducing the inflammatory response. TNF-alpha inhibitors, such as infliximab, target specific inflammatory pathways to control the disease. These mechanisms are important for Sarcoidosis patients as they help manage symptoms, prevent disease progression, and improve quality of life.

Biological role of the soluble interleukin-2 receptor in sarcoidosis.ProKaSaRe Study Protocol: A Prospective Multicenter Study of Pulmonary Rehabilitation of Patients With Sarcoidosis.