Sjogren's SyndromePhase 2ANISE-IINCT05383677
Anifrolumab Treatment for 24 Weeks in Patients With Primary Sjögren's Syndrome
A Phase 2 study testing Anifrolumab in people with Sjogren's Syndrome, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
The ANISE-II study is a randomized, double-blind, placebo-controlled phase IIa proof-of-concept trial. Thirty patients with primary Sjögren's syndrome (pSS) are randomized in a 2:1 ratio to either anifrolumab or placebo treatment for 24 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sjogren's Syndrome
- What is being tested?
- Anifrolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Oct 2022to 1 Aug 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Written informed consent
- Female or male aged ≥18 years
- Disease duration (time since diagnosis) ≤10 years. In case of pediatric-onset pSS a disease duration of ≤15 years is allowed if there is residual gland function (UWS≥0.01 or SWS≥0.1 ml/min).
- Fulfilment of 2016 ACR-EULAR classification criteria for pSS (which includes focus score ≥1 in salivary gland biopsy and/or anti-SSA/Ro positivity), based on previous diagnostic examinations
- Presence of anti-SSA antibodies
- ESSDAI≥5 and/or ESSPRI≥5. ESSDAI≥5 implicates a moderate to high systemic disease activity and ESSPRI≥5 implicates that the patient-reported symptom state is unacceptable. At least 50% of patients need to fulfil the ESSDAI≥5 criterion. Inclusion of patients with low ESSDAI (<5) should be discontinued when 15 included patients (50%) have a low ESSDAI.
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- Willingness to undergo a repeated parotid gland biopsy at baseline and 24 weeks after start treatment. If a recent parotid gland biopsy (within ≤1 year before the baseline visit) is available, and enough material of this parotid gland biopsy is available, this biopsy can be used as baseline sample.
- Use of reliable method of contraception for participants of reproductive potential.
- Vaccinated against COVID-19 (at least two COVID-19 vaccinations) or previous confirmed COVID-19 infection (from which the patient is recovered) in combination with at least one COVID-19 vaccination or a previous confirmed COVID-19 infection (from which the patients has recovered) in combination with a positive anti-SARS-CoV-2 antibody test.
Who cannot join
- Presence of any other connective tissue disease
- Positive pregnancy test (urinary HCG) at screening or breast-feeding
- History of alcohol or drug abuse
- History of malignancy or with a current suspicion for cancer, apart from local MALT lymphoma, squamous or basal cell carcinoma of the skin treated with documented success of curative therapy ≥3 months prior to week 0 or cervical cancer in situ treated with apparent success with curative therapy ≥1 year prior to week 0.
- Subjects with evidence (as assessed by the investigator) of active or latent bacterial or viral infections at the time of potential enrollment, including subjects with evidence of HIV which will be tested during screening.
- History of chronic or recurrent serious infections. (e.g. chronic pyelonephritis, osteomyelitis or bronchiectasis).
Show all 33Show fewer
- Subjects with serious bacterial infections within the last 3 months, unless treated and resolved with antibiotics.
- Opportunistic infection requiring hospitilization or IV antimicrobial treatment within 3 years of randomization
- Any infection requiring hospitalization or treatment with IV anti-infective medications not completed at least 4 weeks prior to signing the ICF.
- Subjects with herpes zoster that resolved less than 12 weeks before potential enrollment or any severe case of herpes zoster in a subjects history, including, but not limited to, non-cutaneous herpes (ever), herpes encephalitis (ever), recurrent herpes zoster (defined as 2 episodes within 2 years) or ophthalmic herpes involving the retina (ever).
- Any clinical cytomegalovirus (CMV) and Epstein-Barr virus (EBV) infection that has not completely resolved within 12 weeks prior to signing the ICF.
- Any history of severe COVID-19 infection (e.g. requiring hospitalization, ICU care or assisted ventilation) or any prior COVID-19 infection with unresolved sequelae. Any acute COVID-19 infection (lab confirmed or suspected based on clinical symptoms) within the last 3 months prior to screening.
- Subjects at risk for TB. Specifically excluded from this study will be subjects with a history of active TB; current clinical, radiographic, or laboratory evidence of active TB, which will be tested during screening; history of latent TB, with the exception of latent TB with documented completion of appropriate treatment.
- Subjects who are positive for hepatitis B surface antigen, which will be tested during screening.
- Subjects who are positive for hepatitis C antibody if the presence of hepatitis C virus was also shown with polymerase chain reaction or recombinant immunoblot assay, which will be tested during screening.
- Subjects who have received any live or attenuated vaccines within 8 weeks prior to signing the ICF.
- Blood transfusion or receipt of blood products within 4 weeks prior to signing the ICF.
- Underlying cardiac, pulmonary, metabolic, renal, hepatic, gastrointestinal, hematological or neurological conditions, chronic or latent infectious diseases or immune deficiency which places the patient at an unacceptable risk for participation in the study.
- Preceding treatment with biological DMARDs, including abatacept, anti-TNF or other monoclonal antibodies within 6 months, and rituximab within 12 months from baseline
- Use of high-dose prednisone, less than 2 weeks before inclusion. Stable low dose (≤10 mg) is allowed.
- Use of hydroxychloroquine, methotrexate, cyclophosphamide, cyclosporine, azathioprine, MMF and leflunomide less than 3 months ago.
- Use of pilocarpine less than 1 month ago.
- Lab abnormalities:
- Serum creatinine > 2.8 mg/dl (250 μmol/l)
- ASAT or ALAT outside 2.5 x upper normal range of the laboratory
- Hb < 9 g/dl (5.6 mmol/l) for males and 8.5 g/dl (5.3 mmol/l) for females
- Neutrophil granulocytes less than 0.5 x 109/l
- Platelet count less than 50 x 109/l
- Any other laboratory test results that, in the opinion of the investigator, might place a subject at unacceptable risk for participation in the study.
- A known history of allergy or reaction to any component of the IP formulation or history of anaphylaxis to any human gamma globuline therapy.
- Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site)
- Previous enrolment or randomisation in the present study
- Participation in another clinical study with an investigational drug during the last 6 months, or local investigational product during the last month
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Centre Groningen
Groningen
Hendrika Bootsma, h.bootsma@umcg.nl
About this study
Official title: ANIfrolumab Treatment for 24 Weeks in Patients With Primary Sjögren's Syndrome - Efficacy and Safety Assessment in a Randomized, Double-blind, Placebo-controlled Phase-IIa Proof-of-concept Trial (ANISE-II)
The ANISE-II study is a randomized, double-blind, placebo-controlled phase IIa proof-of-concept trial. Thirty patients with primary Sjögren's syndrome (pSS) are randomized in a 2:1 ratio to either anifrolumab or placebo treatment for 24 weeks. Main inclusion criteria are fulfilment of the ACR/EULAR classification criteria for pSS, disease duration of ≤10 years, and an ESSDAI and/or ESSPRI of ≥5 (at least 50% of patients need to fulfil the ESSDAI ≥5 criterion). The primary outcome measure is Composite of Relevant Endpoints for Sjögren's Syndrome (CRESS) response at week 24.
Read the detailed description
The aim is to evaluate safety and determine the effects of anifrolumab on essential clinical and biological parameters in patients with primary Sjögren's syndrome (pSS). Although the pathogenesis of pSS has not been fully elucidated, one of the key immune pathways involved is type-I IFN signalling. Since anifrolumab is a fully human, IgG1κ monoclonal antibody to type-I interferon receptor subunit 1, the hypothesis is that inhibition of type-I IFN signalling by anifrolumab may reduce glandular and systemic inflammation and attenuate disease activity in patients with pSS. The study population will consist of patients who fulfil 2016 ACR-EULAR criteria for pSS and have active disease, defined by a EULAR Sjögren Syndrome Disease Activity Index (ESSDAI) score ≥5 and/or an unacceptable patient symptom state (EULAR Sjögren Syndrome Patient Reported Index (ESSPRI) score ≥5. The primary endpoint is the Composite of Relevant Endpoints for Sjögren's Syndrome (CRESS) at week 24.
- Conditions
- Sjogren's Syndrome
- Being tested
- Anifrolumab, Placebo
- Medical subject headings
- Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnifrolumabDrug
Also called Saphnelo
Anifrolumab 300 mg will be administered in intravenous infusions once per 4 weeks, for a total treatment period of 24 weeks.
PlaceboDrug
Placebo will be administered in intravenous infusions once per 4 weeks, for a total treatment period of 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Anifrolumab | Active comparator | 20 patients will receive anifrolumab treatment Receives: Drug: Anifrolumab |
| Placebo | Placebo comparator | 10 patients will receive placebo treatment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of Relevant Endpoints for Sjögren's Syndrome (CRESS) response
The CRESS is a recently developed composite endpoint which consists of five clinically relevant items for pSS: a systemic disease activity, patient-reported symptoms, tear gland, salivary gland and serology item. A CRESS responder is someone who reached response on at least three out of five items (Arends et al., https://doi.org/10.1016/S2665-9913(21)00122-3)
Measured: Week 24
Secondary outcomes (27)
Safety (adverse events and tolerability)
Adverse events and tolerability
Measured: Weeks 0, 4, 8, 12, 16, 20 and 24
Total CRESS response
The CRESS is a recently developed composite endpoint which consists of five clinically relevant items for pSS: a systemic disease activity, patient-reported symptoms, tear gland, salivary gland and serology item. A CRESS responder is someone who reached response on at least three out of five items (Arends et al., https://doi.org/10.1016/S2665-9913(21)00122-3)
Measured: Week 12
ClinESSDAI
Change in ClinESSDAI from baseline, scale 0-135. A higher score means a worse outcome.
Measured: Weeks 0, 8, 12, 20, 24
ESSPRI
Change in ESSPRI from baseline, scale 0-10. A higher score means a worse outcome.
Measured: Weeks 0, 8, 12, 20, 24
Schirmer's test
Change in Schirmer's test from baseline, scale 0-35 mm. A higher score means a better outcome.
Measured: Weeks 0, 12, 24
Ocular Staining Score (OSS)
Change in OSS from baseline, scale 0-12. A higher score means a worse outcome
Measured: Weeks 0, 12, 24.
Salivary gland ultrasonography (SGUS)
Change in total Hocevar score (0-48) from baseline. A higher score means a worse outcome.
Measured: SGUS: weeks 0, 12, 24
Rheumatoid factor (RF)
Change in RF (IU/ml) from baseline. A higher score means a worse outcome.
Measured: Weeks 0, 8, 12, 20, 24
Total IgG
Change in IgG (g/L) from baseline. A higher score means a worse outcome.
Measured: Weeks 0, 8, 12, 20, 24
Unstimulated whole salivary secretion (UWS)
Change in UWS (reported in ml/min) from baseline. A higher score means a better outcome.
Measured: Weeks 0, 12, 24.
ESSDAI
Change in ESSDAI from baseline, scale 0-123. A higher score means a worse outcome.
Measured: Weeks 0, 8, 12, 20, 24
(Clin)ESSDAI minimal clinically important improvement (MCII)
(Clin)ESSDAI MCII is defined as a decrease of ≥3 points
Measured: Weeks 8, 12, 20, 24
(Clin)ESSDAI low disease activity
(Clin)ESSDAI low disease activity is defined as a score<5
Measured: Weeks 8, 12, 20, 24
Physician GDA (PhGDA)
Change in PhGDA from baseline, scale 0-10. A higher score means a worse outcome.
Measured: Weeks 0, 8, 12, 20, 24
NRS score oral, ocular and vaginal dryness
Change in NRS score from baseline, scale 0-10. A higher score means a worse outcome.
Measured: Weeks 0, 8, 12, 20, 24
Patient GDA (PtGDA)
Change in PtGDA from baseline, scale 0-10. A higher score means a worse outcome.
Measured: Weeks 0, 8, 12, 20, 24
Short Form-36 (SF-36) health survey
The SF-36 includes 8 domains, each ranging on a scale from 0-100. A higher score means a better outcome.
Measured: Weeks 0, 12, 24
EurQoL 5 dimensions (EQ-5D) measure of health-related quality of life
The EQ-5D is reported as index value (0-1). A higher score means a better outcome.
Measured: Weeks 0, 8, 12, 20, 24
Multidimensional Fatigue Index (MFI) scale
The MFI is reported on a scale of 4-20 for both physical and mental fatigue. A higher score means a worse outcome.
Measured: Weeks 0, 12, 24
Female Sexual Function Index (FSFI) in females
The FSFI total score has a range of 2-36. A higher score indicates better outcome.
Measured: Weeks 0, 12, 24
SGUS OMERACT score
The OMERACT score is reported on a scale of 0-3. A higher score means a worse outcome.
Measured: Weeks 0, 12, 24
Parotid gland histology: focus score
Number of foci / 4 mm2
Measured: Week 0, 24
Parotid gland histology: area of CD45 infiltrate
Change in are of CD45 infiltrate at week 24 compared to week 0
Measured: Week 0, 24
Serum levels of anti-SSA/SSB
U/ml
Measured: Weeks 0, 8, 12, 20, 24
Complement (C3/C4)
g/L
Measured: Weeks 0, 8, 12, 20, 24
Lymphocyte count
10^9/L
Measured: Weeks 0, 8, 12, 20, 24
Presence of cryoglobulinemia
Presence of cryoglobulinemia (yes/no) will be analysed at week 0, 12 and 24.
Measured: Weeks 0, 12, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start1 Oct 2022
- Primary completion1 May 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjogren's SyndromeStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Hendrika Bootsma, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05383677
- Sponsor's protocol ID
- ESR-21-21284
- Other IDs
- 2022-000609-28
- Acronym
- ANISE-II
- Status last verified
- Dec 2022
- First submitted
- 29 Mar 2022
- Last updated
- 19 Dec 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ANIfrolumab Treatment for 24 Weeks in Patients With Primary Sjögren's Syndrome - Efficacy and Safety Assessment in a Randomized, Double-blind, Placebo-controlled Phase-IIa Proof-of-concept Trial (ANISE-II)
- ClinicalTrials.gov ID
- NCT05383677
- Acronym / sponsor ID
- ANISE-II / ESR-21-21284
- Conditions
- Sjogren's Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 20 May 2022 (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.
The ANISE-II study is a randomized, double-blind, placebo-controlled phase IIa proof-of-concept trial. Thirty patients with primary Sjögren's syndrome (pSS) are randomized in a 2:1 ratio to either anifrolumab or placebo treatment for 24 weeks. Main inclusion criteria are fulfilment of the ACR/EULAR classification criteria for pSS, disease duration of ≤10 years, and an ESSDAI and/or ESSPRI of ≥5 (at least 50% of patients need to fulfil the ESSDAI ≥5 criterion). The primary outcome measure is Composite of Relevant Endpoints for Sjögren's Syndrome (CRESS) response at week 24.
Detailed description
The aim is to evaluate safety and determine the effects of anifrolumab on essential clinical and biological parameters in patients with primary Sjögren's syndrome (pSS). Although the pathogenesis of pSS has not been fully elucidated, one of the key immune pathways involved is type-I IFN signalling. Since anifrolumab is a fully human, IgG1κ monoclonal antibody to type-I interferon receptor subunit 1, the hypothesis is that inhibition of type-I IFN signalling by anifrolumab may reduce glandular and systemic inflammation and attenuate disease activity in patients with pSS. The study population will consist of patients who fulfil 2016 ACR-EULAR criteria for pSS and have active disease, defined by a EULAR Sjögren Syndrome Disease Activity Index (ESSDAI) score ≥5 and/or an unacceptable patient symptom state (EULAR Sjögren Syndrome Patient Reported Index (ESSPRI) score ≥5. The primary endpoint is the Composite of Relevant Endpoints for Sjögren's Syndrome (CRESS) at week 24.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anifrolumab | Active comparator | Drug: Anifrolumab20 patients will receive anifrolumab treatment |
| Placebo | Placebo comparator | Drug: Placebo10 patients will receive placebo treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written informed consent
- Female or male aged ≥18 years
- Disease duration (time since diagnosis) ≤10 years. In case of pediatric-onset pSS a disease duration of ≤15 years is allowed if there is residual gland function (UWS≥0.01 or SWS≥0.1 ml/min).
- Fulfilment of 2016 ACR-EULAR classification criteria for pSS (which includes focus score ≥1 in salivary gland biopsy and/or anti-SSA/Ro positivity), based on previous diagnostic examinations
- Presence of anti-SSA antibodies
Key exclusion criteria (33 listed)
- Presence of any other connective tissue disease
- Positive pregnancy test (urinary HCG) at screening or breast-feeding
- History of alcohol or drug abuse
- History of malignancy or with a current suspicion for cancer, apart from local MALT lymphoma, squamous or basal cell carcinoma of the skin treated with documented success of curative therapy ≥3 months prior to week 0 or cervical cancer in situ treated with apparent success with curative therapy ≥1 year prior to week 0.
- Subjects with evidence (as assessed by the investigator) of active or latent bacterial or viral infections at the time of potential enrollment, including subjects with evidence of HIV which will be tested during 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 |
|---|---|---|
| AnifrolumabAlso: SaphneloAnifrolumab 300 mg will be administered in intravenous infusions once per 4 weeks, for a total treatment period of 24 weeks. | Drug | Anifrolumab |
| PlaceboPlacebo will be administered in intravenous infusions once per 4 weeks, for a total treatment period of 24 weeks. | Drug | Placebo |
Primary outcome
Composite of Relevant Endpoints for Sjögren's Syndrome (CRESS) response
Time frame: Week 24
The CRESS is a recently developed composite endpoint which consists of five clinically relevant items for pSS: a systemic disease activity, patient-reported symptoms, tear gland, salivary gland and serology item. A CRESS responder is someone who reached response on at least three out of five items (Arends et al., https://doi.org/10.1016/S2665-9913(21)00122-3)
27 secondary outcomes
Safety (adverse events and tolerability)
Time frame: Weeks 0, 4, 8, 12, 16, 20 and 24
Total CRESS response
Time frame: Week 12
ClinESSDAI
Time frame: Weeks 0, 8, 12, 20, 24
ESSPRI
Time frame: Weeks 0, 8, 12, 20, 24
Schirmer's test
Time frame: Weeks 0, 12, 24
Ocular Staining Score (OSS)
Time frame: Weeks 0, 12, 24.
Salivary gland ultrasonography (SGUS)
Time frame: SGUS: weeks 0, 12, 24
Rheumatoid factor (RF)
Time frame: Weeks 0, 8, 12, 20, 24
Total IgG
Time frame: Weeks 0, 8, 12, 20, 24
Unstimulated whole salivary secretion (UWS)
Time frame: Weeks 0, 12, 24.
ESSDAI
Time frame: Weeks 0, 8, 12, 20, 24
(Clin)ESSDAI minimal clinically important improvement (MCII)
Time frame: Weeks 8, 12, 20, 24
(Clin)ESSDAI low disease activity
Time frame: Weeks 8, 12, 20, 24
Physician GDA (PhGDA)
Time frame: Weeks 0, 8, 12, 20, 24
NRS score oral, ocular and vaginal dryness
Time frame: Weeks 0, 8, 12, 20, 24
Patient GDA (PtGDA)
Time frame: Weeks 0, 8, 12, 20, 24
Short Form-36 (SF-36) health survey
Time frame: Weeks 0, 12, 24
EurQoL 5 dimensions (EQ-5D) measure of health-related quality of life
Time frame: Weeks 0, 8, 12, 20, 24
Multidimensional Fatigue Index (MFI) scale
Time frame: Weeks 0, 12, 24
Female Sexual Function Index (FSFI) in females
Time frame: Weeks 0, 12, 24
SGUS OMERACT score
Time frame: Weeks 0, 12, 24
Parotid gland histology: focus score
Time frame: Week 0, 24
Parotid gland histology: area of CD45 infiltrate
Time frame: Week 0, 24
Serum levels of anti-SSA/SSB
Time frame: Weeks 0, 8, 12, 20, 24
Complement (C3/C4)
Time frame: Weeks 0, 8, 12, 20, 24
Lymphocyte count
Time frame: Weeks 0, 8, 12, 20, 24
Presence of cryoglobulinemia
Time frame: Weeks 0, 12, 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2022.
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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.
Hendrika Bootsma principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anifrolumab in people with Sjogren's Syndrome, run by University Medical Center Groningen at 1 site in Netherlands.
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 9 inclusion and 33 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: status not confirmed, as of the sponsor's last update on 19 Dec 2022. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hendrika Bootsma (+315036129456, h.bootsma@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of Relevant Endpoints for Sjögren's Syndrome (CRESS) response (time frame: Week 24). 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 19 Dec 2022.