Sarcoidosis, PulmonaryPhase 2RESOLVE-LungNCT05314517
A Study to Assess the Efficacy and Safety of Namilumab in Participants With Chronic Pulmonary Sarcoidosis
A Phase 2 study testing Namilumab in people with Sarcoidosis, Pulmonary, run by Kinevant Sciences GmbH at 47 sites in 7 countries.
Trial summary
This is a randomized, double-blind, placebo-controlled study with an open-label extension (OLE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoidosis, Pulmonary
- What is being tested?
- Namilumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 47 sitesin 7 countries
- Study dates
- 31 Aug 2022to 9 Apr 2025
- 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
- No healthy volunteers
- 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
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
47 sites in 7 countries.
47 sites in 7 countries
United States24 sites
Kinevant Study Site
Augusta, Georgia, 29841
Kinevant Study Site
Baltimore, Maryland, 21234
Kinevant Study Site
Birmingham, Alabama, 35233
Kinevant Study Site
Charleston, South Carolina, 29425
Kinevant Study Site
Charlottesville, Virginia, 22908
Kinevant Study Site
Chicago, Illinois, 60612
Kinevant Study Site
Cincinnati, Ohio, 45219
Kinevant Study Site
Cleveland, Ohio, 44195
Kinevant Study Site
Dallas, Texas, 75390
Kinevant Study Site
Denver, Colorado, 80206
Kinevant Study Site
Falls Church, Virginia, 22042
Kinevant Study Site
Gainesville, Florida, 32610
Kinevant Study Site
Greenville, North Carolina, 27834
Kinevant Study Site
Houston, Texas, 77030
Kinevant Study Site
Iowa City, Iowa, 52242
Kinevant Study Site
Kansas City, Kansas, 66160
Kinevant Study Site
Minneapolis, Minnesota, 55414
Kinevant Study Site
New Orleans, Louisiana, 70115
Kinevant Study Site
Palo Alto, California, 94304
Kinevant Study Site
Philadelphia, Pennsylvania, 19140
Kinevant Study Site
Pittsburgh, Pennsylvania, 15213
Kinevant Study Site
Rochester, Minnesota, 55905
Kinevant Study Site
Rock Hill, South Carolina, 29732
Kinevant Study Site
Valencia, California, 91355
Germany5 sites
Kinevant Study Site
Berlin, 14165
Kinevant Study Site
Essen, 45239
Kinevant Study Site
Freiburg im Breisgau, 79106
Kinevant Study Site
Hanover, 30625
Kinevant Study Site
Heidelberg, 69126
Turkey (Türkiye)5 sites
Kinevant Study Site
Ankara, 06620
Kinevant Study Site
Istanbul, 34134
Kinevant Study Site
Izmir, 35100
Kinevant Study Site
Izmir, 35330
Kinevant Study Site
Mersin, 33110
Belgium4 sites
Kinevant Study Site
Brussels, 1200
Kinevant Study Site
Leuven, 3000
Kinevant Study Site
Liège, B-4000
Kinevant Study Site
Yvoir, 5530
France3 sites
Kinevant Study Site
Bobigny, 93000
Kinevant Study Site
Lille, 59037
Kinevant Study Site
Paris, 75018
Netherlands3 sites
Kinevant Study Site
Leiden, 2333 ZA
Kinevant Study Site
Nieuwegein, 3435 CM
Kinevant Study Site
Rotterdam, 3015 GD
United Kingdom3 sites
Kinevant Study Site
Cambridge, CB20QQ
Kinevant Study Site
Cottingham, HU165JQ
Kinevant Study Site
London, SE59RS
About this study
Official title: A Randomized, Double-blind, Placebo-Controlled Phase 2 Study With Open-label Extension to Assess the Efficacy and Safety of Namilumab in Subjects With Chronic Pulmonary Sarcoidosis
This is a randomized, double-blind, placebo-controlled study with an open-label extension (OLE).
Read the detailed 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.
- Conditions
- Sarcoidosis, Pulmonary
- Being tested
- Namilumab, Placebo
- Medical subject headings
- Sarcoidosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NamilumabDrug
Namilumab administered subcutaneously
PlaceboDrug
Placebo administered subcutaneously to match namilumab dosing
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm 1 | Experimental | Namilumab Receives: Drug: Namilumab |
| Treatment Arm 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With a Rescue Event During the DB 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.
Measured: 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.
Secondary outcomes (5)
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at 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).
Measured: Baseline, Week 26
Time to the First Rescue Event During the DB 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.
Measured: 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.
Percentage of Participants Successfully Achieving OCS Taper Without Rescue Event During the DB Period
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.
Measured: Baseline to Week 26
Change From Baseline in the Kings Sarcoidosis Questionnaire (KSQ) Lung Domain Score at 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 using MMRM.
Measured: Baseline, Week 26
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Period
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.
Measured: Baseline up to Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start31 Aug 2022
- Primary completion16 Oct 2024
- Study completion9 Apr 2025
Why it stopped: Sponsor Decision
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sarcoidosis, PulmonaryStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- A double-blinded, randomized, placebo-controlled, parallel group design has been selected for the study. All participants, regardless of treatment assignment in the Double-blind Treatment Period, may participate in the Open Label Extension period of the study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 107 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
- NCT05314517
- Sponsor's protocol ID
- KIN-1902-2001
- Acronym
- RESOLVE-Lung
- Status last verified
- Jul 2025
- First submitted
- 30 Mar 2022
- Last updated
- 12 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Van Den Blink B, Birring SS, Mogulkoc N, Nayci Atis S, Gupta R, Guiot J, Hart SP, Carmona Porquera EM, Koeller HB, Arocho N, Petit CM, Denning J, Lin M, Baughman RP, Wijsenbeek-Lourens M, Reiss TF; RESOLVE-Lung investigators. Safety and efficacy of namilumab for the treatment of chronic pulmonary sarcoidosis (RESOLVE-Lung): a randomised, double-blinded, multicentre, phase 2 study. Eur Respir J. 2026 Jul 9;68(1):2501874. doi: 10.1183/13993003.01874-2025. Print 2026 Jul.
PubMed 41819539
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-Controlled Phase 2 Study With Open-label Extension to Assess the Efficacy and Safety of Namilumab in Subjects With Chronic Pulmonary Sarcoidosis
- ClinicalTrials.gov ID
- NCT05314517
- Acronym / sponsor ID
- RESOLVE-Lung / KIN-1902-2001
- Conditions
- Sarcoidosis, Pulmonary
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Kinevant Sciences GmbHIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- 16 Oct 2024 (actual)
- Study completion
- 9 Apr 2025 (actual)
- First posted
- 6 Apr 2022 (actual)
- Results
- Posted 12 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, placebo-controlled study with an open-label extension (OLE).
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A double-blinded, randomized, placebo-controlled, parallel group design has been selected for the study. All participants, regardless of treatment assignment in the Double-blind Treatment Period, may participate in the Open Label Extension period of the study.
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm 1 | Experimental | Drug: NamilumabNamilumab |
| Treatment Arm 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 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
- 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
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| NamilumabNamilumab administered subcutaneously | Drug | Treatment Arm 1 |
| PlaceboPlacebo administered subcutaneously to match namilumab dosing | Drug | Treatment Arm 2 |
Primary outcome
Percentage of Participants With a Rescue Event During the DB Period
Time frame: 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.
5 secondary outcomes
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 26
Time frame: Baseline, Week 26
Time to the First Rescue Event During the DB Period
Time frame: 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.
Percentage of Participants Successfully Achieving OCS Taper Without Rescue Event During the DB Period
Time frame: Baseline to Week 26
Change From Baseline in the Kings Sarcoidosis Questionnaire (KSQ) Lung Domain Score at Week 26
Time frame: Baseline, Week 26
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Period
Time frame: Baseline up to Week 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41819539Van Den Blink B, Birring SS, Mogulkoc N, Nayci Atis S, Gupta R, Guiot J, Hart SP, Carmona Porquera EM, Koeller HB, Arocho N, Petit CM, Denning J, Lin M, Baughman RP, Wijsenbeek-Lourens M, Reiss TF; RESOLVE-Lung investigators. Safety and efficacy of namilumab for the treatment of chronic pulmonary sarcoidosis (RESOLVE-Lung): a randomised, double-blinded, multicentre, phase 2 study. Eur Respir J. 2026 Jul 9;68(1):2501874. doi: 10.1183/13993003.01874-2025. Print 2026 Jul.
- 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.
47 sites in 7 countries: 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, Pulmonary, run by Kinevant Sciences GmbH at 47 sites in 7 countries.
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 6 inclusion and 12 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 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States, Germany, Turkey (Türkiye), Belgium, France and 2 more countries. 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. Some participants in this study may receive a placebo. 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 12 Sep 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?
Percentage of Participants With a Rescue Event During the DB Period (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05314517, which also lists 1 linked publication.
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 12 Sep 2025.