SarcoidosisNCT06576505
Immunological Mechanisms in Sarcoidosis
An observational study of Sarcoidosis, run by Region Stockholm at 1 site in Sweden.
Trial summary
There is no cure for the inflammatory disease sarcoidosis. Virtually any part of the body can be affected but most often the lungs and lymph nodes. Outcomes after diagnosis vary widely among sarcoidosis patients, with some experiencing resolving disease and others developing chronic disease and lung fibrosis. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcoidosis
- What is being tested?
- peripheral blood sampling, bronchoscopy, upper airway and faeces sampling
- Type of treatment
- Surgery or procedure
- How many people
- 5,000 participants
- Where
- 1 siteSweden
- Study dates
- 7 Jul 2024to 31 Dec 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with/with a suspicion of sarcoidosis referred to Department of Respiratory Medicine, Karolinska University Hospital, Stockholm, Sweden. A total of 4600 patients are planned to be included during 10 years (460/year). Healthy volunteers will be recruited through advertisments (web based platforms within Karolinska Institutet, magazines, notice-boards). A total of 400 are planned to be included during 10 years (40/year).
Who may be able to join
- Suspicion of sarcoidosis
- Swedish speaking
- Able to understand and approve of study protocol
- No contraindications for planned interventions
- For inclusion of healthy controls they need to be healthy and the same criteria as listed above for patients.
Who cannot join
- No suspicion of sarcoidosis
- Not Swedish-speaking
- Not able to understand study protocol
- Not approving of study protocol
- Contraindications for planned interventions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm, Stockholm County, 171 76
Susanna Kullberg, MD, 070-2715639 ext. +46, susanna.kullberg@regionstockholm.se
About this study
Official title: Immunologiska Mekanismer Vid Sarkoidos
There is no cure for the inflammatory disease sarcoidosis. Virtually any part of the body can be affected but most often the lungs and lymph nodes. Outcomes after diagnosis vary widely among sarcoidosis patients, with some experiencing resolving disease and others developing chronic disease and lung fibrosis. Cardiac sarcoidosis can lead to life threatening arrythmias and calcium metabolism disturbances can lead to renal impairment.
Treatment with different forms of immunosuppressants are usually tried to dampen symptoms but are not effective in all patients. Furthermore, the disease usually flares up after cessation of treatment. The variability in diseae course and treatment response is thought, at least to some degree, to be explained by individual differences in genetics, immune cells and signaling pathways. But existing evidence is limited. In other inflammatory diseases the gut microbiome is of importance for disease course but its role in sarcoidosis has not been clarified.
Read more
In this prospective project the investigators will study genes, inflammatory cells and signaling molecules in the lung, upper airways and blood, and to some extent microbes, also in faeces. Healthy volunteers will be included for comparative studies. Most samples will be taken during normal diagnostic work-up and follow-up of patients with/with suspected sarcoidosis. The findings will be correlated to disease course and effects of different treatments. By linking to national health data and demographic registries, comorbidities and environmental factors will be correlated to data.
By this, the investigators hope to improve understanding of which genes, cells and signaling molecules that are of importance for resolving vs non-resolving disease and why some patients respond to a certain treatment and others don´t. The overall goal is to assess and predict sarcoidosis outcomes. We hypothesize that blood-based biomarkers including those taken during routine care as well as novel cell, signaling molecules and genetic markers, in combination with clinical characteristics can be used to predict outcomes, also treatment response, in sarcoidosis. The results can lead to tailored treatment and individual follow-up for each patient with sarcoidosis.
- Conditions
- Sarcoidosis
- Being tested
- peripheral blood sampling, bronchoscopy, upper airway and faeces sampling
- Medical subject headings
- Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peripheral blood sampling, bronchoscopy, upper airway and faeces samplingProcedure or surgery
- Repeated peripheral blood sampling at diagnostic and follow-up visits, in total a maximum of 400 ml/year but never more than 100 ml/ month.
- Upper airway sampling wih swab, aspirate and curettage, maximum 3 times/year.
- Faeces sampling, the patients do this themselves and leave it to the research unit, maximum 3 times/year.
- Bronchoscopy with lavage and a maximum of 6 mucosal biopsies before and after 6-12 months treatment.
| Study group | Role | What they receive |
|---|---|---|
| Sarcoidosis patients | This study only consists of one arm. The investigators follow patients prospectively and observe clinical parameters including disease course (resolving, non-resolving, which organs are involved, inflammatory markers, chest X-ray etc) and effect of treatment. In this respect the study is observational. However, the patients undergo repeated peripheral blood samples and some also undergo sampling from upper airways, faeces and a bronchoscopy and hence, the study falls in the interventional category Receives: Procedure: peripheral blood sampling, bronchoscopy, upper airway and faeces sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease activity
This refers to cardiac sarcoidosis and is estimated with PET-CT
Measured: 3 months and 12 months
Number of participants with resolving vs non-resolving disease
Data will be collected from the medical record wether the disease resolved or not
Measured: 2 and 5 years from baseline
Number of participants with immunosuppressive treatment
Data on treatment will be collected from the medical record
Measured: 5 years
Number of participants with more than 10% change from enrollment in percent of predicted Forced Expiratory Volume in one second (L/s) at 5 years
Measured with spirometry
Measured: Baseline and 5 years
Change from enrollment in Immunoglobulin G (g/L) at 5 years
Measured in serum
Measured: Baseline and 5 years
Change from enrollment in fatigue at 5 years
The Fatigue Assessment Scale will be used. Maximum score is 50 and minimum 10. A higher score means more fatigue.More than 22 points means the participant suffers from fatigue and more than 34 extreme fatigue.
Measured: Baseline and 5 years
Change from enrollment of radiographic findings at 5 years
Chest X-ray will be classified according to Scadding staging
Measured: Baseline and 5 years
Change from enrollment of angiotensin converting enzyme (E/L) at 5 years
Measured in serum
Measured: Baseline and 5 years
Change from enrollment of soluble Interleukin Receptor 2 (U/ml) at 5 years
Measured in serum
Measured: Baseline and 5 years
Change from enrollment of complete blood cell count (/10x9 L) at 5 years
Measured in blood
Measured: Baseline and 5 years
Change from enrollment of creatinine levels (micromol/L) at 5 years
Measured in plasma
Measured: Baseline and 5 years
Change from enrollment of C-reactive protein (mg/L) at 5 years
Measured in serum
Measured: Baseline and 5 years
Number of patients with more than 10% change from enrollment in percent of predicted Diffusing capacity of the Lungs for Carbon Monoxide (%) at 5 years
Measured with spirometry
Measured: Baseline and 5 years
Number of participants with more than 10% change from enrollment in percent of predicted Forced Vital Capacity (L) at 5 years
Measured with spirometry
Measured: Baseline and 5 years
Change from enrollment of calcium levels (mmol/L) at 5 years
Measured in serum
Measured: Baseline and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start7 Jul 2024
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- More trials run by Region StockholmThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet
- Responsible party
- Sponsor
- Investigators
- Susanna M Kullberg, MD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576505
- Sponsor's protocol ID
- K2024-5925
- Status last verified
- Mar 2026
- First submitted
- 12 Aug 2024
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunologiska Mekanismer Vid Sarkoidos
- ClinicalTrials.gov ID
- NCT06576505
- Acronym / sponsor ID
- K2024-5925
- Conditions
- Sarcoidosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Karolinska Institutet
- Study start
- 7 Jul 2024 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2034 (estimated)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is no cure for the inflammatory disease sarcoidosis. Virtually any part of the body can be affected but most often the lungs and lymph nodes. Outcomes after diagnosis vary widely among sarcoidosis patients, with some experiencing resolving disease and others developing chronic disease and lung fibrosis. Cardiac sarcoidosis can lead to life threatening arrythmias and calcium metabolism disturbances can lead to renal impairment.
Treatment with different forms of immunosuppressants are usually tried to dampen symptoms but are not effective in all patients. Furthermore, the disease usually flares up after cessation of treatment. The variability in diseae course and treatment response is thought, at least to some degree, to be explained by individual differences in genetics, immune cells and signaling pathways. But existing evidence is limited. In other inflammatory diseases the gut microbiome is of importance for disease course but its role in sarcoidosis has not been clarified.
In this prospective project the investigators will study genes, inflammatory cells and signaling molecules in the lung, upper airways and blood, and to some extent microbes, also in faeces. Healthy volunteers will be included for comparative studies. Most samples will be taken during normal diagnostic work-up and follow-up of patients with/with suspected sarcoidosis. The findings will be correlated to disease course and effects of different treatments. By linking to national health data and demographic registries, comorbidities and environmental factors will be correlated to data.
By this, the investigators hope to improve understanding of which genes, cells and signaling molecules that are of importance for resolving vs non-resolving disease and why some patients respond to a certain treatment and others don´t. The overall goal is to assess and predict sarcoidosis outcomes. We hypothesize that blood-based biomarkers including those taken during routine care as well as novel cell, signaling molecules and genetic markers, in combination with clinical characteristics can be used to predict outcomes, also treatment response, in sarcoidosis. The results can lead to tailored treatment and individual follow-up for each patient with sarcoidosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sarcoidosis patients | – | Procedure: peripheral blood sampling, bronchoscopy, upper airway and faeces samplingThis study only consists of one arm. The investigators follow patients prospectively and observe clinical parameters including disease course (resolving, non-resolving, which organs are involved, inflammatory markers, chest X-ray etc) and effect of treatment. In this respect the study is observational. However, the patients undergo repeated peripheral blood samples and some also undergo sampling from upper airways, faeces and a bronchoscopy and hence, the study falls in the interventional category |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with/with a suspicion of sarcoidosis referred to Department of Respiratory Medicine, Karolinska University Hospital, Stockholm, Sweden. A total of 4600 patients are planned to be included during 10 years (460/year). Healthy volunteers will be recruited through advertisments (web based platforms within Karolinska Institutet, magazines, notice-boards). A total of 400 are planned to be included during 10 years (40/year).
Key inclusion criteria (5 listed)
- Suspicion of sarcoidosis
- Swedish speaking
- Able to understand and approve of study protocol
- No contraindications for planned interventions
- For inclusion of healthy controls they need to be healthy and the same criteria as listed above for patients.
Key exclusion criteria (5 listed)
- No suspicion of sarcoidosis
- Not Swedish-speaking
- Not able to understand study protocol
- Not approving of study protocol
- Contraindications for planned interventions
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 |
|---|---|---|
| peripheral blood sampling, bronchoscopy, upper airway and faeces sampling1. Repeated peripheral blood sampling at diagnostic and follow-up visits, in total a maximum of 400 ml/year but never more than 100 ml/ month. 2. Upper airway sampling wih swab, aspirate and curettage, maximum 3 times/year. 3. Faeces sampling, the patients do this themselves and leave it to the research unit, maximum 3 times/year. 4. Bronchoscopy with lavage and a maximum of 6 mucosal biopsies before and after 6-12 months treatment. | Procedure or surgery | Sarcoidosis patients |
Primary outcome
Disease activity
Time frame: 3 months and 12 months
This refers to cardiac sarcoidosis and is estimated with PET-CT
Number of participants with resolving vs non-resolving disease
Time frame: 2 and 5 years from baseline
Data will be collected from the medical record wether the disease resolved or not
Number of participants with immunosuppressive treatment
Time frame: 5 years
Data on treatment will be collected from the medical record
Number of participants with more than 10% change from enrollment in percent of predicted Forced Expiratory Volume in one second (L/s) at 5 years
Time frame: Baseline and 5 years
Measured with spirometry
Change from enrollment in Immunoglobulin G (g/L) at 5 years
Time frame: Baseline and 5 years
Measured in serum
Change from enrollment in fatigue at 5 years
Time frame: Baseline and 5 years
The Fatigue Assessment Scale will be used. Maximum score is 50 and minimum 10. A higher score means more fatigue.More than 22 points means the participant suffers from fatigue and more than 34 extreme fatigue.
Change from enrollment of radiographic findings at 5 years
Time frame: Baseline and 5 years
Chest X-ray will be classified according to Scadding staging
Change from enrollment of angiotensin converting enzyme (E/L) at 5 years
Time frame: Baseline and 5 years
Measured in serum
Change from enrollment of soluble Interleukin Receptor 2 (U/ml) at 5 years
Time frame: Baseline and 5 years
Measured in serum
Change from enrollment of complete blood cell count (/10x9 L) at 5 years
Time frame: Baseline and 5 years
Measured in blood
Change from enrollment of creatinine levels (micromol/L) at 5 years
Time frame: Baseline and 5 years
Measured in plasma
Change from enrollment of C-reactive protein (mg/L) at 5 years
Time frame: Baseline and 5 years
Measured in serum
Number of patients with more than 10% change from enrollment in percent of predicted Diffusing capacity of the Lungs for Carbon Monoxide (%) at 5 years
Time frame: Baseline and 5 years
Measured with spirometry
Number of participants with more than 10% change from enrollment in percent of predicted Forced Vital Capacity (L) at 5 years
Time frame: Baseline and 5 years
Measured with spirometry
Change from enrollment of calcium levels (mmol/L) at 5 years
Time frame: Baseline and 5 years
Measured in serum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
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A Study of Brepocitinib in Adults With Cutaneous Sarcoidosis
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LAM-001 for the Treatment of Sarcoidosis Associated Pulmonary Hypertension (SAPH)
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Sarcoidosis
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.
Susanna M Kullberg, MD principal investigator
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoidosis, run by Region Stockholm at 1 site in Sweden.
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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susanna M Kullberg, MD (070-2715639 ext. +46, susanna.kullberg@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease activity (time frame: 3 months and 12 months). The study lists 15 primary outcomes in all. 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 6 Mar 2026.