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

Kinevant Sciences

Status and phase: Terminated; Phase 2

Conditions: Sarcoidosis, Pulmonary

Treatments: Drug: Placebo; Drug: Namilumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05314517

KIN-1902-2001

Details and patient eligibility

About

This is a randomized, double-blind, placebo-controlled study with an open-label extension (OLE).

Full 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.

Enrollment: 107 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 scan consistent with active 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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107 participants in 2 patient groups, including a placebo group

Treatment Arm 1

Experimental group

Description:

Namilumab

Treatment:

Drug: Namilumab

Treatment Arm 2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo