Monoclonal Antibodies
Namilumab for Sarcoidosis
Kinevant Study Site, Cottingham, United Kingdom
Namilumab +1 morePhase 2RecruitingResearch Sponsored by Kinevant Sciences GmbHEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Body Mass Index (BMI) ≤ 40 kg/m2 at Screening
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
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upbaseline to week 26
Awards & highlights
Study Summary
This trial is studying whether a combination of two drugs is better than either drug alone in treating patients with advanced melanoma.
Eligible Conditions
- Sarcoidosis
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
Your body mass index (BMI), a measure of body fat based on height and weight, is less than or equal to 40 kg/m2.
Select...
You have a condition called sarcoidosis that affects your lungs and causes difficulty breathing. This is confirmed by a high resolution CT scan and other medical tests that show increased activity in your lungs.
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
100%
80%
60%
40%
20%
0%
Study treatment Arm
Open-Label Period: Namilumab 150 mg
Follow-up Period: Namilumab 20 mg
Double-Blind Period: Namilumab 150 mg
Follow-up Period: Placebo
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
Find a site
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 Director
Kinevant SciencesHayes Dansky, MDStudy Director
Kinevant Sciences1 Previous Clinical Trials
1 Total Patients Enrolled
1 Trials studying Sarcoidosis
1 Patients Enrolled for Sarcoidosis
Media Library
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