Sarcoidosis, CardiacPhase 2RESOLVE-HeartNCT05351554
A Study to Assess the Safety, Tolerability, and Efficacy of Namilumab in Participants With Active Cardiac Sarcoidosis
A Phase 2 study testing Namilumab in people with Sarcoidosis, Cardiac, run by Kinevant Sciences GmbH at 12 sites in United States.
Trial summary
A Randomized, Double-blind, Placebo-controlled, Study with an Open-label Cohort. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcoidosis, Cardiac
- What is being tested?
- Namilumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 12 sitesUnited States
- Study dates
- 23 Aug 2022to 13 Dec 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Kinevant Study Site
Ann Arbor, Michigan, 48109
Kinevant Study Site
Baltimore, Maryland, 21234
Kinevant Study Site
Boston, Massachusetts, 02115
Kinevant Study Site
Charleston, South Carolina, 29425
Kinevant Study Site
Cleveland, Ohio, 44195
Kinevant Study Site
Denver, Colorado, 80206
Kinevant Study Site
Gainesville, Florida, 32610
Kinevant Study Site
Iowa City, Iowa, 52242
Kinevant Study Site
New Haven, Connecticut, 06519
Kinevant Study Site
New York, New York, 10029
Kinevant Study Site
Palo Alto, California, 94304
Kinevant Study Site
Portland, Oregon, 97239
About this study
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
A Randomized, Double-blind, Placebo-controlled, Study with an Open-label Cohort.
Read the detailed description
Study was terminated after a single participant had received 2 doses.
- Conditions
- Sarcoidosis, Cardiac
- Being tested
- Namilumab
- Medical subject headings
- Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NamilumabDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Namilumab | Experimental | A single participant received two doses of 150 milligrams (mg) of namilumab subcutaneously (SC) at baseline (Day 1) and on Day 15. Receives: Drug: Namilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to approximately 2 months
Secondary outcomes (17)
Number of Participants With Treatment-emergent Laboratory Abnormalities
Measured: Baseline up to approximately 2 months
Number of Participants With Treatment-emergent Vital Sign Abnormalities
Measured: Baseline up to approximately 2 months
Number of Participants With Treatment-emergent Electrocardiogram (ECG) Abnormalities
Measured: Baseline up to approximately 2 months
Mean Change From Baseline in Positron Emission Tomography (PET) Maximum Standardized Update Value (SUVmax)
Measured: Baseline up to approximately 2 months
Change From Baseline in PET Mean Standardized Update Value (SUVmean)
Measured: Baseline up to approximately 2 months
Mean Change From Baseline in Total Glycosylation
Measured: Baseline up to approximately 2 months
Number of Participants Hospitalized for Cardiac Events
Measured: Baseline up to approximately 2 months
Mean Change From Baseline in Left Ventricular Ejection Fraction (LVEF)
Measured: Baseline up to approximately 2 months
Mean Change From Baseline in Global Longitudinal Strain (GLS) on Transthoracic Echocardiogram (TTE)
Measured: Baseline up to approximately 2 months
Cumulative Oral Steroid Use
Measured: Baseline up to approximately 2 months
Modified Glucocorticoid Toxicity Index (mGTI)
The mGTI is a composite measure of the changes in OCS toxicity measured at 3-month intervals across 11 domains and 23 items. For the purposes of this study, radiographic assessment of bone mineral density is not being performed; therefore, this item is not being assessed in the tool and the tool is termed "modified" for this study. The change in the total score is from -35 to +410 with the exclusion of bone mineral density, with minimum score representing least toxicity (better outcomes) and maximum score representing most toxicity (worse outcomes).
Measured: Baseline up to approximately 2 months
Mean Change From Baseline in Glycosylated Hemoglobin (HbA1C)
Measured: Baseline up to approximately 2 months
Number of Participants Requiring Rescue Therapy
Measured: Baseline up to approximately 2 months
Number of Participants Successfully Achieving Steroid Taper Without Requiring Rescue Therapy (Cohort A)
Measured: Baseline up to approximately 2 months
Mean Change From Baseline in King's Sarcoidosis Questionnaire (KSQ)
The KSQ is a modular, multi-organ health status measure for participants with sarcoidosis for use in the clinic and the evaluation of therapies. The KSQ consists of 5 modules: General health status (10 items), Lung (6 items), Medication (3 items), Skin (3 items), and Eye (7 items). Results are given as a number between 1-100 with higher numbers indicating better health.
Measured: Baseline up to approximately 2 months
Change From Baseline in Fatigue Assessment Scale (FAS)
The FAS is a 10-item self-reported fatigue questionnaire. Participants indicate their responses on a 5-point scale (from 1 never to 5 always). Total scores on the FAS can therefore range from 10 to 50, with high scores indicating more fatigue and worse outcomes.
Measured: Baseline up to approximately 2 months
Change From Baseline in Subject Global Assessment (SGA)
The SGA is a participant reported outcome instrument used to assess their overall perception of the frequency and severity of sarcoid symptoms. The SGA is a 5-point Likert scale; the participant rates how he/she feels regarding their sarcoidosis in the previous 2 weeks prior to the study visit based on the frequency and severity of their symptoms. Scores range from 1 to 5 with lower scores representing better outcomes.
Measured: Baseline up to approximately 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start23 Aug 2022
- Primary completion15 Nov 2022
- Study completion13 Dec 2022
Why it stopped: Sponsor business decision not related to safety
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sarcoidosis, CardiacStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kinevant Sciences GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351554
- Sponsor's protocol ID
- KIN-1902-2002
- Acronym
- RESOLVE-Heart
- Status last verified
- Feb 2025
- First submitted
- 4 Apr 2022
- Last updated
- 17 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05351554
- Acronym / sponsor ID
- RESOLVE-Heart / KIN-1902-2002
- Conditions
- Sarcoidosis, Cardiac
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor business decision not related to safety
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Kinevant Sciences GmbHIndustry (pharma, biotech, devices)
- Study start
- 23 Aug 2022 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 13 Dec 2022 (actual)
- First posted
- 28 Apr 2022 (actual)
- Results
- Posted 17 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Namilumab | Experimental | Drug: NamilumabA single participant received two doses of 150 milligrams (mg) of namilumab subcutaneously (SC) at baseline (Day 1) and on Day 15. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NamilumabSpecified dose on specified days | Drug | Namilumab |
Primary outcome
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation
Time frame: Baseline up to approximately 2 months
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.
17 secondary outcomes
Number of Participants With Treatment-emergent Laboratory Abnormalities
Time frame: Baseline up to approximately 2 months
Number of Participants With Treatment-emergent Vital Sign Abnormalities
Time frame: Baseline up to approximately 2 months
Number of Participants With Treatment-emergent Electrocardiogram (ECG) Abnormalities
Time frame: Baseline up to approximately 2 months
Mean Change From Baseline in Positron Emission Tomography (PET) Maximum Standardized Update Value (SUVmax)
Time frame: Baseline up to approximately 2 months
Change From Baseline in PET Mean Standardized Update Value (SUVmean)
Time frame: Baseline up to approximately 2 months
Mean Change From Baseline in Total Glycosylation
Time frame: Baseline up to approximately 2 months
Number of Participants Hospitalized for Cardiac Events
Time frame: Baseline up to approximately 2 months
Mean Change From Baseline in Left Ventricular Ejection Fraction (LVEF)
Time frame: Baseline up to approximately 2 months
Mean Change From Baseline in Global Longitudinal Strain (GLS) on Transthoracic Echocardiogram (TTE)
Time frame: Baseline up to approximately 2 months
Cumulative Oral Steroid Use
Time frame: Baseline up to approximately 2 months
Modified Glucocorticoid Toxicity Index (mGTI)
Time frame: Baseline up to approximately 2 months
Mean Change From Baseline in Glycosylated Hemoglobin (HbA1C)
Time frame: Baseline up to approximately 2 months
Number of Participants Requiring Rescue Therapy
Time frame: Baseline up to approximately 2 months
Number of Participants Successfully Achieving Steroid Taper Without Requiring Rescue Therapy (Cohort A)
Time frame: Baseline up to approximately 2 months
Mean Change From Baseline in King's Sarcoidosis Questionnaire (KSQ)
Time frame: Baseline up to approximately 2 months
Change From Baseline in Fatigue Assessment Scale (FAS)
Time frame: Baseline up to approximately 2 months
Change From Baseline in Subject Global Assessment (SGA)
Time frame: Baseline up to approximately 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Namilumab in people with Sarcoidosis, Cardiac, run by Kinevant Sciences GmbH at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation (time frame: Baseline up to approximately 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025; AzTrials last refreshed its copy on 6 Nov 2026.