NCT05314517: RESOLVE-Lung

A Study to Assess the Efficacy and Safety of Namilumab in Participants With Chronic Pulmonary Sarcoidosis

Terminated Phase 2 Results posted Last updated 12 September 2025

What this trial tests

Phase 2 trial testing Namilumab in Sarcoidosis, Pulmonary in 107 participants. Terminated before completion.

Timeline

31 August 2022

Primary endpoint
16 October 2024

9 April 2025

Quick facts

Lead sponsor	Kinevant Sciences GmbH
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	107
Start date	31 August 2022
Primary completion	16 October 2024
Estimated completion	9 April 2025
Sites	47 locations across France, Netherlands, Belgium, United Kingdom, Germany, United States, Turkey (Türkiye)

Drugs / interventions tested

• Namilumab — full drug profile →
• Placebo

Conditions studied

• Sarcoidosis, Pulmonary — all drugs for Sarcoidosis, Pulmonary →

Sponsor

Kinevant Sciences GmbH — full company profile →

Who can join

18 and older, any sex, with Sarcoidosis, Pulmonary. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With a Rescue Event During the DB Period Primary · Baseline to Week 26 for participants continuing to OLE and up to Week 30 for participants not continuing to OLE, as rescue events occurring within 8 weeks of last dose were included in the analysis for participants not continuing to the OLE period.

Rescue events included: Participants with worsening sarcoidosis requiring rescue treatment; and participants failing to follow protocol defined concomitant sarcoidosis medication requirements (oral corticosteroids \[OCS\] taper/immunosuppressive therapy \[IST\] removal/prohibited medication). Participants with premature treatment discontinuation in the DB period without rescue event were considered as with missing rescue event status and excluded from analysis.

Group	Value	95% CI
Namilumab	37.5	27.0 – 49.4
Placebo	23.5	15.2 – 34.5

Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 26 Secondary · Baseline, Week 26

FVC is the volume of air (in liters) that can be forcibly blown out after full inspiration in the upright position. Percent of predicted FVC = (actual FVC measurement)/(predicted value of FVC) \* 100. Least square (LS) mean and standard error (SE) were calculated using mixed model for repeated measure (MMRM).

Group	Value	95% CI
Namilumab	-3.28	± 1.058
Placebo	-2.92	± 0.967

Time to the First Rescue Event During the DB Period Secondary · Baseline to Week 26 for participants continuing to OLE and up to Week 30 for participants not continuing to OLE, as rescue events occurring within 8 weeks of last dose were included in the analysis for participants not continuing to the OLE period.

Time of first rescue event was defined as the time from randomization to the rescue event date. Rescue events included: Participants with worsening sarcoidosis requiring rescue treatment; and participants failing to follow protocol defined concomitant sarcoidosis medication requirements (OCS taper/IST removal/prohibited medication). Data was calculated using the Kaplan-Meier estimator.

Group	Value	95% CI
Namilumab	11.0	1.0 – 26.6
Placebo	12.86	3.0 – 22.1

Percentage of Participants Successfully Achieving OCS Taper Without Rescue Event During the DB Period Secondary · Baseline to Week 26

Percentage of participants achieving OCS taper (achieving OCS dose ≤5 milligrams \[mg\] at end of Week 10 \[Day 77\] for participants with baseline OCS \>10 mg/day, achieving ≤ 5 mg at end of Week 6 \[Day 49\] for participants with baseline OCS \>5 to ≤10 mg/day) without any rescue event during the DB period for participants with OCS \>5 mg/day at baseline are reported.

Group	Value	95% CI
Namilumab	53.3	33.3 – 72.3
Placebo	76.9	54.2 – 90.4

Change From Baseline in the Kings Sarcoidosis Questionnaire (KSQ) Lung Domain Score at Week 26 Secondary · Baseline, Week 26

The KSQ has 29 questions (items 1 to 16, and items 26-38). The KSQ Lung domain score was calculated based on items 11 to 16. Each item was answered on a 7-point scale where 1 means the participant experienced symptoms all the time and 7 means the participant did not experience the symptom at all. The raw item scores were first converted into item re-scores using the first conversion step. Then, the re-scores for the 6 items were totaled and the total converted into the logit 1 (worst symptom) - 100 (no symptom) score, where higher score indicating better health. LS mean and SE were calculated

Group	Value	95% CI
Namilumab	1.61	± 1.866
Placebo	3.47	± 1.771

Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Period Secondary · Baseline up to Week 26

An adverse event (AE) was any untoward medical occurrence in a participant administered the study drug and which did not necessarily have a causal relationship with this treatment. TEAEs are those AEs with start date on or after the start date of treatment through the earlier of 18-week post last dose during DB period or prior to first dose during OLE period, whichever was earlier. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

Group	Value	95% CI
Namilumab	49
Placebo	51

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose to 18 weeks after last dose (up to 68 weeks). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Namilumab

Serious: 3/52 (6%)

Deaths: 0/52

Placebo

Serious: 3/54 (6%)

Deaths: 0/54

Namilumab to Namilumab

Serious: 7/52 (13%)

Deaths: 0/52

Placebo to Namilumab

Serious: 5/49 (10%)

Deaths: 0/49

Serious adverse events (17 terms)

Reaction	System	Namilumab	Placebo	Namilumab to Namilumab	Placebo to Namilumab
Lower respiratory tract infection	Infections and infestations	—	—	—	—
Intestinal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Hypoglycaemia	Metabolism and nutrition disorders	—	—	—	—
Seizure	Nervous system disorders	—	—	—	—
Ventricular fibrillation	Cardiac disorders	—	—	—	—
Atrioventricular block complete	Cardiac disorders	—	—	—	—
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Pulmonary sarcoidosis	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Chronic spontaneous urticaria	Skin and subcutaneous tissue disorders	—	—	—	—
Lower respiratory tract infection viral	Infections and infestations	—	—	—	—
Depression	Psychiatric disorders	—	—	—	—
Conduction disorder	Cardiac disorders	—	—	—	—
Coronary artery disease	Cardiac disorders	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Gastric ulcer haemorrhage	Gastrointestinal disorders	—	—	—	—
Inguinal hernia	Gastrointestinal disorders	—	—	—	—
Menometrorrhagia	Reproductive system and breast disorders	—	—	—	—

Other adverse events (343 terms — click to expand)

Reaction	System	Namilumab	Placebo	Namilumab to Namilumab	Placebo to Namilumab
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Pulmonary sarcoidosis	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—
Fatigue	General disorders	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
COVID-19	Infections and infestations	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Sinus congestion	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—
Injection site pain	General disorders	—	—	—	—
Influenza like illness	General disorders	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—
Influenza	Infections and infestations	—	—	—	—
Anxiety	Psychiatric disorders	—	—	—	—
Productive cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—
Non-cardiac chest pain	General disorders	—	—	—	—
Asthenia	General disorders	—	—	—	—
Blood creatinine increased	Investigations	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—
Eosinophilia	Blood and lymphatic system disorders	—	—	—	—
Hypercalcaemia	Metabolism and nutrition disorders	—	—	—	—
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Wheezing	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—
Night sweats	Skin and subcutaneous tissue disorders	—	—	—	—

Most-reported serious reactions: Lower respiratory tract infection, Intestinal adenocarcinoma, Hypoglycaemia, Seizure, Ventricular fibrillation, Atrioventricular block complete, Acute respiratory failure, Pulmonary sarcoidosis.

Data from ClinicalTrials.gov NCT05314517 adverse events section.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Biologic drugs in the treatment of chronic inflammatory pulmonary diseases: recent developments and future perspectives.
   Plichta J, Kuna P, Panek M. · · 2023 · cited 34× · PMID 37334374 · DOI 10.3389/fimmu.2023.1207641
2. Sarcoidosis: Updates on therapeutic drug trials and novel treatment approaches.
   Obi ON, Saketkoo LA, Russell AM, Baughman RP. · · 2022 · cited 31× · PMID 36314034 · DOI 10.3389/fmed.2022.991783
3. Targeting Progression in Pulmonary Fibrosis: An Overview of Underlying Mechanisms, Molecular Biomarkers, and Therapeutic Intervention.
   D'Agnano V, Mariniello DF, Ruotolo M, Quarcio G, et al · · 2024 · cited 10× · PMID 38398739 · DOI 10.3390/life14020229
4. Molecularly Targeted Therapies for Inflammatory Cutaneous Granulomatous Disorders: A Review of the Evidence and Implications for Understanding Disease Pathogenesis.
   Hwang E, Abdelghaffar M, Shields BE, Damsky W. · · 2023 · cited 5× · PMID 37719661 · DOI 10.1016/j.xjidi.2023.100220
5. Emerging Therapeutic Options for Refractory Pulmonary Sarcoidosis: The Evidence and Proposed Mechanisms of Action.
   Nelson NC, Kogan R, Condos R, Hena KM. · · 2023 · cited 2× · PMID 38202021 · DOI 10.3390/jcm13010015
6. Advanced interstitial lung disease: Evidence-based management and clinical approach.
   Kattih Z, Greenstein Z, Makkar P, Gupta R. · · 2025 · cited 1× · PMID 40699491 · DOI 10.36141/svdld.v42i2.16206
7. A new era in the treatment of progressive fibrosing interstitial lung diseases.
   Denis A, Tsiri P, Guiot J, Tzouvelekis A. · · 2025 · cited 1× · PMID 40529319 · DOI 10.1183/20734735.0259-2024
8. Safety and efficacy of namilumab for the treatment of chronic pulmonary sarcoidosis (RESOLVE-Lung): A randomized, double-blinded, multicenter, Phase 2 study.
   Van Den Blink B, Birring SS, Mogulkoc N, Atis SN, et al · · 2026 · PMID 41819539 · DOI 10.1183/13993003.01874-2025