Clinical trial NCT05351554: A Study to Assess the Safety, Tolerability, and Efficacy of Namilumab in Participants With Active Cardiac Sarcoidosis
Official title: A Randomized, Double-blind, Placebo-controlled, Phase 2a Study With an Open-label Cohort to Assess the Safety, Tolerability, and Efficacy of Namilumab in Subjects With Active Cardiac Sarcoidosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Sarcoidosis, Cardiac
Lead sponsor: Kinevant Sciences GmbH
Sponsor class: INDUSTRY
First posted: 2022-04-28
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A Randomized, Double-blind, Placebo-controlled, Study with an Open-label Cohort.

Detailed description: Study was terminated after a single participant had received 2 doses.

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
* History of documented sarcoidosis (must include histological confirmation, from any organ, in the subject's medical history or records)
* Meet Heart Rhythm Society Cardiac Sarcoid Diagnostic Criteria (modified)
* Female subjects must agree to use an approved highly effective birth control (BC) method
* Male subjects must agree to, and attest that, female partners of childbearing potential are using one of the allowed highly effective methods of contraception
* Body Mass Index (BMI) \<40 kg/m2 at Screening.
* Vaccination for COVID-19 with completion of the primary series at least 2 weeks prior to randomization

Exclusion Criteria:

* Hospitalized for any respiratory or cardiac illness ≤30 days prior to Screening
* Known pulmonary hypertension requiring therapy
* Autoimmune disease other than sarcoidosis likely to require treatment during the subject's participation in this study
* Symptoms and/or signs of extracardiac sarcoidosis that are likely to warrant treatment in addition to that required for the subject's cardiac disease
* Estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73 m2 (Modification of Diet in Renal Disease \[MDRD\] equation) or requiring renal replacement therapy
* Hemoglobin ≤9.5 g/dL
* Participation in another interventional clinical trial within 6 months prior to Screening and throughout the duration of participation in this study
* Systolic blood pressure (SBP) \<90 or \>180 mm Hg; Diastolic blood pressure (DBP) \<60 or \>110 mm Hg at Screening
* Has documented laboratory-confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR) or other approved clinical testing ≤3 months prior to randomization
* Significant valvular heart disease known or anticipated to require surgical repair or replacement during the subjects' participation in this study
* Female subjects who are pregnant or breastfeeding or intend to be, during the study
* History of severe allergic or anaphylactic reactions to therapeutic proteins or known sensitivity to namilumab or to its inactive components
* Any other acute or chronic medical condition, 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.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation
timeFrame: Baseline up to approximately 2 months
Secondary outcomes:
measure: Number of Participants With Treatment-emergent Laboratory Abnormalities
timeFrame: Baseline up to approximately 2 months
measure: Number of Participants With Treatment-emergent Vital Sign Abnormalities
timeFrame: Baseline up to approximately 2 months
measure: Number of Participants With Treatment-emergent Electrocardiogram (ECG) Abnormalities
timeFrame: Baseline up to approximately 2 months
measure: Mean Change From Baseline in Positron Emission Tomography (PET) Maximum Standardized Update Value (SUVmax)
timeFrame: Baseline up to approximately 2 months
measure: Change From Baseline in PET Mean Standardized Update Value (SUVmean)
timeFrame: Baseline up to approximately 2 months
measure: Mean Change From Baseline in Total Glycosylation
timeFrame: Baseline up to approximately 2 months
measure: Number of Participants Hospitalized for Cardiac Events
timeFrame: Baseline up to approximately 2 months
measure: Mean Change From Baseline in Left Ventricular Ejection Fraction (LVEF)
timeFrame: Baseline up to approximately 2 months
measure: Mean Change From Baseline in Global Longitudinal Strain (GLS) on Transthoracic Echocardiogram (TTE)
timeFrame: Baseline up to approximately 2 months
measure: Cumulative Oral Steroid Use
timeFrame: Baseline up to approximately 2 months
measure: Modified Glucocorticoid Toxicity Index (mGTI)
timeFrame: Baseline up to approximately 2 months
measure: Mean Change From Baseline in Glycosylated Hemoglobin (HbA1C)
timeFrame: Baseline up to approximately 2 months
measure: Number of Participants Requiring Rescue Therapy
timeFrame: Baseline up to approximately 2 months
measure: Number of Participants Successfully Achieving Steroid Taper Without Requiring Rescue Therapy (Cohort A)
timeFrame: Baseline up to approximately 2 months
measure: Mean Change From Baseline in King's Sarcoidosis Questionnaire (KSQ)
timeFrame: Baseline up to approximately 2 months
measure: Change From Baseline in Fatigue Assessment Scale (FAS)
timeFrame: Baseline up to approximately 2 months
measure: Change From Baseline in Subject Global Assessment (SGA)
timeFrame: Baseline up to approximately 2 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Kinevant Study Site
state: California
city: Denver
country: United States
facility: Kinevant Study Site
state: Colorado
city: New Haven
country: United States
facility: Kinevant Study Site
state: Connecticut
city: Gainesville
country: United States
facility: Kinevant Study Site
state: Florida
city: Iowa City
country: United States
facility: Kinevant Study Site
state: Iowa
city: Baltimore
country: United States
facility: Kinevant Study Site
state: Maryland
city: Boston
country: United States
facility: Kinevant Study Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Kinevant Study Site
state: Michigan
city: New York
country: United States
facility: Kinevant Study Site
state: New York
city: Cleveland
country: United States
facility: Kinevant Study Site
state: Ohio
city: Portland
country: United States
facility: Kinevant Study Site
state: Oregon
city: Charleston
country: United States
facility: Kinevant Study Site
state: South Carolina
Study officials:
References: