A Study to Assess the Safety, Tolerability, and Efficacy of Namilumab in Participants With Active Cardiac Sarcoidosis

NCT05351554 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: KIN-1902-2002
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 12

Brief Summary

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

Conditions

Sarcoidosis, Cardiac

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation

  An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

  Baseline up to approximately 2 months

Secondary Outcomes (17)

• Number of Participants With Treatment-emergent Laboratory Abnormalities

  Baseline up to approximately 2 months

• Number of Participants With Treatment-emergent Vital Sign Abnormalities

  Baseline up to approximately 2 months

• Number of Participants With Treatment-emergent Electrocardiogram (ECG) Abnormalities

  Baseline up to approximately 2 months

• Mean Change From Baseline in Positron Emission Tomography (PET) Maximum Standardized Update Value (SUVmax)

  Baseline up to approximately 2 months

• Change From Baseline in PET Mean Standardized Update Value (SUVmean)

  Baseline up to approximately 2 months

Study Arms (1)

Namilumab

EXPERIMENTAL

A single participant received two doses of 150 milligrams (mg) of namilumab subcutaneously (SC) at baseline (Day 1) and on Day 15.

Drug: Namilumab

Interventions

Namilumab DRUG

Specified dose on specified days

Namilumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kinevant Sciences GmbH: lead

Study Sites (12)

Kinevant Study Site

Palo Alto, California, 94304, United States

Location

Kinevant Study Site

Denver, Colorado, 80206, United States

Location

Kinevant Study Site

New Haven, Connecticut, 06519, United States

Location

Kinevant Study Site

Gainesville, Florida, 32610, United States

Location

Kinevant Study Site

Iowa City, Iowa, 52242, United States

Location

Kinevant Study Site

Baltimore, Maryland, 21234, United States

Location

Kinevant Study Site

Boston, Massachusetts, 02115, United States

Location

Kinevant Study Site

Ann Arbor, Michigan, 48109, United States

Location

Kinevant Study Site

New York, New York, 10029, United States

Location

Kinevant Study Site

Cleveland, Ohio, 44195, United States

Location

Kinevant Study Site

Portland, Oregon, 97239, United States

Location

Kinevant Study Site

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Sarcoidosis

Interventions

namilumab

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Limitations and Caveats

The sponsor terminated the study for business reasons, not related to safety, after a single participant had received 2 doses. No efficacy analyses were performed and no conclusions can be drawn due to the limited data available.

Results Point of Contact

• Title: Study Director
• Organization: Kinevant

kinevant.resolve-heart@kinevant.com

Please email

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 28, 2022
• Study Start: August 23, 2022
• Primary Completion: November 15, 2022
• Study Completion: December 13, 2022
• Last Updated: April 17, 2025
• Results First Posted: April 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)