Your session is about to expire
← Back to Search
Monoclonal Antibodies
Namilumab for Chronic Pulmonary Sarcoidosis (RESOLVE-Lung Trial)
Phase 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 26
Awards & highlights
RESOLVE-Lung Trial Summary
This trial is studying whether a combination of two drugs is better than either drug alone in treating patients with advanced melanoma.
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.Check my eligibility
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.See study design
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.
RESOLVE-Lung Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have sarcoidosis with breathing difficulty and worsening symptoms or a reaction to reduced medication.
Select...
I have a confirmed sarcoidosis diagnosis for 6 months or more.
Select...
I have had trouble breathing when moving around in the last 6 months.
Select...
I am 18 years old or older.
RESOLVE-Lung Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 26
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 26
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of subjects requiring rescue treatment for worsening of sarcoidosis
Secondary outcome measures
Change in Percent Predicted Forced Vital Capacity (ppFVC)
Change in the modified Kings Sarcoidosis Questionnaire (mKSQ) Lung domain score
Number of Subjects positive for ADA to namilumab
+3 moreSide effects data
From 2016 Phase 2 trial • 122 Patients • NCT021297774%
Nasopharyngitis
4%
Upper respiratory tract infection
100%
80%
60%
40%
20%
0%
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
RESOLVE-Lung 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
Find a Location
Who is running the clinical trial?
Kinevant Sciences GmbHLead Sponsor
3 Previous Clinical Trials
264 Total Patients Enrolled
1 Trials studying Sarcoidosis
1 Patients Enrolled for Sarcoidosis
Ted Reiss, MDStudy DirectorKinevant Sciences
Hayes Dansky, MDStudy DirectorKinevant Sciences
1 Previous Clinical Trials
1 Total Patients Enrolled
1 Trials studying Sarcoidosis
1 Patients Enrolled for Sarcoidosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lung scan shows I have significant scarring.I have sarcoidosis with breathing difficulty and worsening symptoms or a reaction to reduced medication.I am not pregnant, breastfeeding, nor plan to be during the study.I completed my initial COVID-19 vaccination series over 2 weeks ago.I have a confirmed sarcoidosis diagnosis for 6 months or more.Your body mass index (BMI) is less than 40 kg/m2.I have had trouble breathing when moving around in the last 6 months.I was hospitalized for a lung or breathing problem within the last 30 days.I had COVID-19 with lung issues or long COVID symptoms, confirmed by a test within the last 6 months.You have heart test results that need more checking by a doctor.Your hemoglobin level is lower than 9.5 grams per deciliter.I am 18 years old or older.I have not received any treatment for my condition.Your body mass index (BMI) is less than or equal to 40 kg/m2.Your blood pressure is too low or too high when checked at the screening.I have a lung condition that stops me from doing a breathing test properly.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm 1
- Group 2: Treatment Arm 2
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How extensive is the recruitment process for this medical experiment?
"Yes, according to clinicaltrials.gov the trial is currently engaging with potential participants. Initially posted on April 30th 2022 and recently updated on November 22nd 2022, this study seeks 100 individuals across 16 different sites."
Answered by AI
Are there still opportunities for enrollment in this trial?
"The information on clinicaltrials.gov attests to the fact that the recruitment process for this medical study is ongoing; it was first introduced in April 2022 and recently refreshed at the end of November."
Answered by AI
Has Namilumab received regulatory clearance from the FDA?
"Despite the lack of efficacy data, namilumab was given a safety score of 2 due to limited evidence pointing towards its safety."
Answered by AI
How many sites have oversight of this trial?
"At present, this medical study is being conducted at 16 sites located in Pittsburgh, Charlottesville, Rochester and an array of other cities. Those looking to participate should pick a local site whenever possible so as to reduce travel related strain on themselves."
Answered by AI
Who else is applying?
What state do they live in?
Georgia
How old are they?
18 - 65
What site did they apply to?
Kinevant Study Site
What portion of applicants met pre-screening criteria?
Met criteria
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger