A Study to Assess the Efficacy and Safety of Namilumab in Participants With Chronic Pulmonary Sarcoidosis (RESOLVE-Lung)

• ClinicalTrials.gov Identifier: NCT05314517
• Recruitment Status: Recruiting
• First Posted: April 6, 2022
• Last Update Posted: March 2, 2023
• Sponsor: Kinevant Sciences GmbH
• Information provided by (Responsible Party): Kinevant Sciences GmbH

Tracking Information

• First Submitted Date: March 30, 2022
• First Posted Date: April 6, 2022
• Last Update Posted Date: March 2, 2023
• Actual Study Start Date: April 30, 2022
• Estimated Primary Completion Date: May 2024 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 2, 2023): Proportion of subjects requiring rescue treatment for worsening of sarcoidosis [ Time Frame: Baseline to Week 26 ]
• Original Primary Outcome Measures (submitted: March 30, 2022): Mean Change from Baseline in Percent Predicted Forced Vital Capacity (ppFVC) [ Time Frame: Baseline to Week 26 ]

Current Secondary Outcome Measures (submitted: February 2, 2023)

• Change in Percent Predicted Forced Vital Capacity (ppFVC) [ Time Frame: Baseline to Week 26 ]
• Time To Rescue Treatment [ Time Frame: Baseline to Week 26 ]
• Proportion of subjects successfully achieving oral corticosteroid (OCS) taper without rescue treatment [ Time Frame: Baseline to Week 26 ]
• Change in the modified Kings Sarcoidosis Questionnaire (mKSQ) Lung domain score [ Time Frame: Baseline to Week 26 ]
• Safety and Tolerability [ Time Frame: Baseline to Week 26 ]
  Number of subjects with adverse events, serious adverse events and other clinically relevant findings.
• Number of Subjects positive for ADA to namilumab [ Time Frame: Baseline to Week 26 ]

Original Secondary Outcome Measures (submitted: March 30, 2022)

• Oral Corticosteroid Taper without Rescue [ Time Frame: Baseline to Week 26 ]
  Proportion of participants successfully achieving oral corticosteroid taper without rescue
• Safety and Tolerability [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline to Week 26 in the double-blind period; Week 26 to Week 54 in the open label extension period ]
• Rescue Therapy [ Time Frame: 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 [ Time Frame: Baseline to Week 26 in the double-blind period; Week 26 to Week 54 in the open label extension period ]
• Safety Laboratory Assessments [ Time Frame: 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 [ Time Frame: Baseline of double-blind to week 26 ]
• Fluorodeoxyglucose Positron Emission Tomography [ Time Frame: Baseline of double-blind to week 26 ]
  Measure of the mean change from baseline in [18-F] fluorodeoxyglucose positron emission tomography
• Walking Capacity [ Time Frame: 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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Assess the Efficacy and Safety of Namilumab in Participants With Chronic Pulmonary Sarcoidosis
• Official Title: A Randomized, Double-blind, Placebo-Controlled Phase 2 Study With Open-label Extension to Assess the Efficacy and Safety of Namilumab in Subjects With Chronic Pulmonary Sarcoidosis
• Brief Summary: This is a randomized, double-blind, placebo-controlled study with an open-label extension (OLE).

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 Type: Interventional
• Study Phase: Phase 2

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

A double-blinded, randomized, placebo-controlled, parallel group design has been selected for the study. All participants, regardless of treatment assignment in the Double-blind Treatment Period, may participate in the Open Label Extension period of the study.

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

Study drug will be provided in a blinded fashion and packaged and labeled to protect the blind.

Primary Purpose: Treatment

• Condition: Sarcoidosis, Pulmonary

Intervention

• Drug: Namilumab
  Namilumab administered subcutaneously
• Drug: Placebo
  Placebo administered subcutaneously to match namilumab dosing

Study Arms

• Experimental: Treatment Arm 1
  Namilumab
  Intervention: Drug: Namilumab
• Placebo Comparator: Treatment Arm 2
  Placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 30, 2022): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 2025
• Estimated Primary Completion Date: May 2024 (Final data collection date for primary outcome measure)

Eligibility 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
• 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
• 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 or during 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, during screening and throughout the duration of the study
• ECG abnormalities that warrant further clinical investigation or management at Screening
• Systolic blood pressure (SBP) <90 or >180mm Hg; Diastolic blood pressure (DBP) <60 or >110 mm Hg at Screening
• Has documented laboratory-confirmed SARS-CoV-2 infection with pulmonary involvement or signs/symptoms of long COVID as determined by approved testing ≤ 6 months prior to randomization
• Other significant pulmonary disease or conditions that prevent subject from performing acceptable spirometry
• 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
• Subjects who are treatment naive

Other protocol-defined inclusion/exclusion criteria apply.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Gary Barrera; 650-303-7132; kinevant.resolve-lung@kinevant.com

• Listed Location Countries: Belgium, France, Netherlands, United States

Administrative Information

• NCT Number: NCT05314517
• Other Study ID Numbers: KIN-1902-2001
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Kinevant Sciences GmbH
• Original Responsible Party: Same as current
• Current Study Sponsor: Kinevant Sciences GmbH
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Hayes Dansky, MD; Kinevant Sciences

• PRS Account: Kinevant Sciences GmbH
• Verification Date: March 2023