RESOLVE-Lung: A Study to Assess the Efficacy and Safety of Namilumab in Participants With Chronic Pulmonary Sarcoidosis
Study Details
Study Description
Brief Summary
This is a randomized, double-blind, placebo-controlled study with an open-label extension (OLE).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
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-blind Treatment Period of the study. Namilumab, or placebo, will be administered subcutaneously (SC) every 4 weeks through Week 22 after the initial dosing period.
All participants, who complete the 26-week Double-blind Treatment Period, may be eligible to participate in the 28-week OLE.
Further details are in the protocol.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment Arm 1 Namilumab |
Drug: Namilumab
Namilumab administered subcutaneously
|
| Placebo Comparator: Treatment Arm 2 Placebo |
Drug: Placebo
Placebo administered subcutaneously to match namilumab dosing
|
Outcome Measures
Primary Outcome Measures
- Mean Change from Baseline in Percent Predicted Forced Vital Capacity (ppFVC) [Baseline to Week 26]
Secondary Outcome Measures
- Oral Corticosteroid Taper without Rescue [Baseline to Week 26]
Proportion of participants successfully achieving oral corticosteroid taper without rescue
- Safety and Tolerability [Baseline to Week 26 in the double-blind period; Week 26 to Week 54 in the open label extension period]
Number of participants with adverse events, serious adverse events and other clinically relevant findings
- Change in Pulmonary Function [Baseline to Week 26 in the double-blind period; Week 26 to Week 54 in the open label extension period]
Mean change from baseline in various pulmonary function tests
- Mean Change from Baseline in Patient Reported Outcomes (PROs) [Baseline to Week 26 in the double-blind period; Week 26 to Week 54 in the open label extension period]
The PROs will measure signs and symptoms of sarcoidosis, pain, fatigue and quality of life
- Cumulative Oral Corticosteroid use and Toxicity Index [Baseline to Week 26 in the double-blind period; Week 26 to Week 54 in the open label extension period]
Measure of the cumulative oral corticosteroid use and toxicity index
- Clinical Benefit Rate [Baseline to Week 26 in the double-blind period; Week 26 to Week 54 in the open label extension period]
Percent of participants achieving clinical benefit
- Mean Change from Baseline in the Sarcoidosis Activity and Severity Index [Baseline to Week 26 in the double-blind period; Week 26 to Week 54 in the open label extension period]
- Mean Change from Baseline in Extrapulmonary Physician Organ Severity Tool [Baseline to Week 26 in the double-blind period; Week 26 to Week 54 in the open label extension period]
- Rescue Therapy [Baseline of double-blind to week 26]
Proportion of participants requiring use of rescue therapy
- Assessments of Population Pharmacokinetics (PPK) and Exposure Response (E-R) relationships for safety and efficacy, if data permits [Baseline to Week 26 in the double-blind period; Week 26 to Week 54 in the open label extension period]
- Safety Laboratory Assessments [Baseline to Week 26 in the double-blind period; Week 26 to Week 54 in the open label extension period]
Number of participants with potentially clinically important laboratory findings
- Mean Change from Baseline in High-Resolution Computed Tomography [Baseline of double-blind to week 26]
- Fluorodeoxyglucose Positron Emission Tomography [Baseline of double-blind to week 26]
Measure of the mean change from baseline in [18-F] fluorodeoxyglucose positron emission tomography
- Walking Capacity [Baseline to Week 26 in the double-blind period; Week 26 to Week 54 in the open label extension period]
Measure of the mean change from baseline in 6-minute walk distance
Eligibility Criteria
Criteria
Inclusion Criteria :
-
Male or female age ≥18 years
-
Able and willing to provide written informed consent, which includes compliance with study requirements and restrictions listed in the consent form
-
Greater than or equal to 6-month history of documented sarcoidosis including histological confirmation in the subject's medical records
-
Symptomatic as indicated by Medical Research Council Dyspnea scale >1 (i.e., Grade 2 or more) in the prior 6 months
-
Body Mass Index (BMI) <40 kg/m2 at Screening
-
Vaccinations for COVID-19 with completion of the primary series at least 2 weeks prior to randomization
Exclusion Criteria
-
Hospitalized for any respiratory illness <30 days prior to Screening
-
Greater than or equal to 20% fibrosis as indicated on HRCT-scan assessed by central read prior to randomization
-
Hemoglobin <9.5 g/dL
-
Participation in another interventional clinical trial (IP/Device) within 6 months prior to Screening
-
ECG abnormalities that warrant further clinical investigation or management at Screening
-
Systolic blood pressure (SBP) <90 or >180mm Hg; Diastolic blood pressure (DBP) <60
-
Has documented laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other approved clinical testing <3 months prior to randomization
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Other significant pulmonary disease likely to interfere with the primary endpoint
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Females who are pregnant or breastfeeding or intend to be during the course of the study
-
Any other acute or chronic medical condition, psychiatric condition, or laboratory abnormality, that in the judgment of the Investigator or Sponsor, may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation of study results, and would make the participant inappropriate for entry into this study
Other protocol-defined inclusion/exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kinevant Study Site | Gainesville | Florida | United States | 32610 |
| 2 | Kinevant Study Site | Kansas City | Kansas | United States | 66160 |
| 3 | Kinevant Study Site | Minneapolis | Minnesota | United States | 55414 |
| 4 | Kinevant Study Site | Greenville | North Carolina | United States | 27834 |
| 5 | Kinevant Study Site | Rock Hill | South Carolina | United States | 29732 |
Sponsors and Collaborators
- Kinevant Sciences GmbH
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KIN-1902-2001