Sjogren's Syndrome (SS)Phase 2NCT05217472
An Efficacy and Safety Study of Injectable Ravagalimab to Assess Change in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) in Adult Participants With Moderately to Severely Active Primary Sjogren's Syndrome (pSS)
A Phase 2 study testing Ravaglimab and Ravagalimab in people with Sjogren's Syndrome (SS), run by AbbVie at 1 site in Netherlands.
Trial summary
Sjogren's syndrome (SS) is a chronic, multisystem autoimmune disease characterized by lacrimal and salivary gland inflammation, with resultant dryness of the eyes and mouth and occasional glandular enlargement. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sjogren's Syndrome (SS)
- What is being tested?
- Ravaglimab and Ravagalimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 Mar 2020to 15 May 2022
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary Sjogren's syndrome (pSS) diagnosed according to the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2016 Criteria.
- Lymphocyte focus score (local lymphocytic infiltrates) >= 1 in sublabial salivary gland specimen. Subjects with sublabial salivary gland biopsy obtained 3 months prior to Screening and meeting this criterion will be eligible without a biopsy at Screening. Subjects without a sublabial salivary gland biopsy within 3 months of Screening will obtain a biopsy for a lymphocyte focus score at Screening.
- EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) >= 5 at Screening.
- EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) >= 6 at Screening.
Who cannot join
- History of clinically significant drug or alcohol abuse within the last 6 months.
- History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients), the ingredients of Chinese hamster ovary cells and/or other products in the same class.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Universitair Medisch Centrum Utrecht /ID# 214029
Utrecht, 3584 CX
About this study
Official title: A Phase 2a, Double-Blind, Randomized, Placebo-Controlled Study of Ravagalimab in Subjects With Moderately to Severely Active Primary Sjogren's Syndrome
Sjogren's syndrome (SS) is a chronic, multisystem autoimmune disease characterized by lacrimal and salivary gland inflammation, with resultant dryness of the eyes and mouth and occasional glandular enlargement. In addition, a variety of systemic manifestations may occur; including fatigue, musculoskeletal symptoms, rashes, and internal organ (e.g., pulmonary, renal, hepatic, and neurologic) disease. Sjogren's syndrome may occur in isolation, primary Sjogren's syndrome (pSS), or in a secondary form, often associated with rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), or systemic sclerosis. Ravagalimab is an investigational drug being developed to help treat patients with inflammatory diseases like SS. This study will evaluate how well ravagalimab works within the body and how safe it is in patients with primary SS (pSS).
Ravagalimab, a potent CD40 antagonist is an investigational drug being developed for the treatment of Sjogren's syndrome (SS). This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given which study drug. Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. Participants 18-75 years of age with Sjogren's syndrome (SS) will be enrolled. Around 45 participants will be enrolled in the study in multiple sites within Netherlands.
Read more
Participants will receive ravagalimab intravenous (IV) loading dose or IV placebo at baseline followed by subcutaneous (SC) ravagalimab or matching placebo for 22 weeks.
There will be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, labial gland (lip) biopsy, and checking for side effects and completing questionnaires.
- Conditions
- Sjogren's Syndrome (SS)
- Being tested
- Ravaglimab, Ravagalimab, Placebo
- Keywords
- Sjogren's Syndrome (SS), Primary Sjogren's Syndrome (pSS), Ravagalimab, ABBV-323
- 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.
RavaglimabDrug
Also called ABBV-323
Intravenous Injection
RavagalimabDrug
Also called ABBV-323
Subcutaneous Injection
PlaceboDrug
Intravenous Injection
PlaceboDrug
Subcutaneous Injection
| Study group | Role | What they receive |
|---|---|---|
| Ravagalimab | Experimental | Participants will receive a loading dose of intravenous (IV) ravagalimab dose A at Week 0 followed by subcutaneous (SC) ravagalimab dose A every other week (eow) Receives: Drug: Ravaglimab; Drug: Ravagalimab |
| Placebo | Placebo comparator | Participants will receive a loading dose of intravenous (IV) placebo at Week 0 followed by subcutaneous (SC) placebo every other week (eow) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)
ESSDAI is a systemic disease activity index including 12 domains (i.e., organ systems: cutaneous, respiratory, renal, articular, muscular, peripheral nervous system, central nervous system, haematological, glandular, constitutional, lymphadenopathic and biological).
Measured: Week 24
Secondary outcomes (24)
Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)
ESSDAI is a systemic disease activity index including 12 domains (i.e., organ systems: cutaneous, respiratory, renal, articular, muscular, peripheral nervous system, central nervous system, haematological, glandular, constitutional, lymphadenopathic and biological).
Measured: Up to Week 16
Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)
ESSPRI is designed to evaluate the patient symptoms with 3 questions related to the dryness, pain and fatigue a participant has experienced in the prior 2 weeks. It is a numeric rating scale from 0 - 10, with a final score the mean of the 3 questions
Measured: Up to Week 24
Change From Baseline in Tender Joint Count
An assessment of 68 joints will be done for tenderness by pressure manipulation on physical examination. Joint pain/tenderness will be classified as: present, absent, replaced or no assessment.
Measured: Up to Week 24
Change From Baseline in Swollen Joint Count
An assessment of 66 joints will be done by directed physical examination. The joints to be examined for swelling are the same as those examined for tenderness, except the hip joints are excluded. Joint swelling will be classified as present, absent, replaced or no assessment.
Measured: Up to Week 24
Change From Baseline in Salivary Flow (Unstimulated)
Patients will be asked to collect their saliva in a cup every 30 seconds for a total period of 5 minutes. The saliva production is expressed in ml/minute.
Measured: Up to Week 24
Change From Baseline in Salivary Flow (Stimulated)
Saliva production is stimulated by parafilm and collected in a cup every 30 seconds for a total period of 5 minutes.. The saliva production is expressed in ml/minute.
Measured: Up to Week 24
Change From Baseline in Lacrimal Flow (Schirmer's Test of Ocular Function)
Lachrymal flow will be assessed by Schirmer's test of ocular function. A small filter paper will be placed in the conjunctival sac for 5 minutes. After that, the degree of wetting is evaluated
Measured: Up to Week 24
Change From Baseline in Van Bijsterveld Score
The van Bijsterveld score is an ocular score for dryness. The Bijsterveld score is determined by adding up the combined score (from 0 to 3; 0 is normal and 3 is the highest level of staining) in the central and two outer sections of the eye.
Measured: Up to Week 24
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
FACIT-Fatigue is a 13-item questionnaire that evaluates fatigue/tiredness and its impact on daily activities and functioning in chronic diseases. This instrument includes items such as tiredness, weakness, listlessness, lack of energy, and the impact of these feelings on daily functioning (e.g., sleeping, and social activities). A lower score indicates less negative impact on daily activities.
Measured: Up to Week 24
Change From Baseline in Patient's Global Assessment of Disease Activity Numeric Rating Scales
Patient's Global Assessment of Disease Activity Numeric Rating Scale allows a patient to score 0 - 10 to assess the patient's overall functionality assessment considering the disease activity within the past week
Measured: Up to Week 24
Change From Baseline in Physician's Global Assessment of Disease Activity Numeric Rating Scales
Physician's Global Assessment of Disease Activity Numeric Rating Scale allows a physician to score 0 - 10 to assess the patient's overall functionality assessment considering the disease activity within the past week.
Measured: Up to Week 24
Change from Baseline in anti-Sjogrens-syndrome-related antigen A (anti-SSA)
Change from baseline in anti-SSA s assessed.
Measured: Up to Week 24
Change from Baseline in anti-Sjogrens-syndrome-related antigen B (anti-SSB)
Change from baseline in anti-SSB is assessed.
Measured: Up to Week 24
Change from Baseline in antinuclear antibody (ANA)
Change from baseline in antinuclear antibody (ANA) is assessed.
Measured: Up to Week 24
Change from Baseline in rheumatoid factor (RF)
Change from baseline in rheumatoid factor (RF) is assessed.
Measured: Up to Week 24
Change from Baseline in high-sensitivity C-reactive protein (hsCRP)
Change from baseline in high-sensitivity C-reactive protein (hsCRP) is assessed.
Measured: Up to Week 24
Change from Baseline in immunoglobulin M (IgM)
Change from baseline in immunoglobulin M (IgM) is assessed
Measured: Up to Week 24
Change from Baseline in immunoglobulin M (IgG)
Change from baseline in immunoglobulin M (IgG) is assessed.
Measured: Up to Week 24
Change from Baseline in immunoglobulin A (IgA)
Change from baseline in immunoglobulin A (IgA) is assessed.
Measured: Up to Week 24
Change from Baseline in Serum-Free Light Chains
Change from baseline in serum-free light chains is assessed.
Measured: Up to Week 24
Change from Baseline in Serum C3
Change from baseline in Serum C3 is assessed.
Measured: Up to Week 24
Change from Baseline in Serum C4
Change from baseline in Serum C4 is assessed.
Measured: Up to Week 24
Change from Baseline in Haemolytic Complement CH50
Change from baseline in CH50 is assessed.
Measured: Up to Week 24
Change From Baseline in Focus Score of Sublabial Salivary Gland Biopsy (In Participants With a Screening and Week 24 Biopsy)
Change from baseline in focus score of sublabial salivary gland biopsy is assessed.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start6 Mar 2020 (estimated)
- Primary completion15 Apr 2022 (estimated)
- Study completion15 May 2022 (estimated)
Why it stopped: Study canceled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjogren's Syndrome (SS)Studies of the same condition, open and under way.
- More trials run by AbbVieThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05217472
- Sponsor's protocol ID
- M21-263
- Other IDs
- 2019-003131-31, 2019
- Status last verified
- Feb 2020
- First submitted
- 6 Feb 2020
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Double-Blind, Randomized, Placebo-Controlled Study of Ravagalimab in Subjects With Moderately to Severely Active Primary Sjogren's Syndrome
- ClinicalTrials.gov ID
- NCT05217472
- Acronym / sponsor ID
- M21-263
- Conditions
- Sjogren's Syndrome (SS)
- Keywords
- Sjogren's Syndrome (SS), Primary Sjogren's Syndrome (pSS), Ravagalimab, ABBV-323
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study canceled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2020 (estimated)
- Primary completion
- 15 Apr 2022 (estimated)
- Study completion
- 15 May 2022 (estimated)
- First posted
- 1 Feb 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.
Sjogren's syndrome (SS) is a chronic, multisystem autoimmune disease characterized by lacrimal and salivary gland inflammation, with resultant dryness of the eyes and mouth and occasional glandular enlargement. In addition, a variety of systemic manifestations may occur; including fatigue, musculoskeletal symptoms, rashes, and internal organ (e.g., pulmonary, renal, hepatic, and neurologic) disease. Sjogren's syndrome may occur in isolation, primary Sjogren's syndrome (pSS), or in a secondary form, often associated with rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), or systemic sclerosis. Ravagalimab is an investigational drug being developed to help treat patients with inflammatory diseases like SS. This study will evaluate how well ravagalimab works within the body and how safe it is in patients with primary SS (pSS).
Ravagalimab, a potent CD40 antagonist is an investigational drug being developed for the treatment of Sjogren's syndrome (SS). This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given which study drug. Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. Participants 18-75 years of age with Sjogren's syndrome (SS) will be enrolled. Around 45 participants will be enrolled in the study in multiple sites within Netherlands.
Participants will receive ravagalimab intravenous (IV) loading dose or IV placebo at baseline followed by subcutaneous (SC) ravagalimab or matching placebo for 22 weeks.
There will be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, labial gland (lip) biopsy, and checking for side effects and completing questionnaires.
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 |
|---|---|---|
| Ravagalimab | Experimental | Drug: Ravaglimab, Drug: RavagalimabParticipants will receive a loading dose of intravenous (IV) ravagalimab dose A at Week 0 followed by subcutaneous (SC) ravagalimab dose A every other week (eow) |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a loading dose of intravenous (IV) placebo at Week 0 followed by subcutaneous (SC) placebo every other week (eow) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary Sjogren's syndrome (pSS) diagnosed according to the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2016 Criteria.
- Lymphocyte focus score (local lymphocytic infiltrates) >= 1 in sublabial salivary gland specimen. Subjects with sublabial salivary gland biopsy obtained 3 months prior to Screening and meeting this criterion will be eligible without a biopsy at Screening. Subjects without a sublabial salivary gland biopsy within 3 months of Screening will obtain a biopsy for a lymphocyte focus score at Screening.
- EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) >= 5 at Screening.
- EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) >= 6 at Screening.
Key exclusion criteria (2 listed)
- History of clinically significant drug or alcohol abuse within the last 6 months.
- History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients), the ingredients of Chinese hamster ovary cells and/or other products in the same class.
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 |
|---|---|---|
| RavaglimabAlso: ABBV-323Intravenous Injection | Drug | Ravagalimab |
| RavagalimabAlso: ABBV-323Subcutaneous Injection | Drug | Ravagalimab |
| PlaceboIntravenous Injection | Drug | Placebo |
| PlaceboSubcutaneous Injection | Drug | Placebo |
Primary outcome
Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)
Time frame: Week 24
ESSDAI is a systemic disease activity index including 12 domains (i.e., organ systems: cutaneous, respiratory, renal, articular, muscular, peripheral nervous system, central nervous system, haematological, glandular, constitutional, lymphadenopathic and biological).
24 secondary outcomes
Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)
Time frame: Up to Week 16
Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)
Time frame: Up to Week 24
Change From Baseline in Tender Joint Count
Time frame: Up to Week 24
Change From Baseline in Swollen Joint Count
Time frame: Up to Week 24
Change From Baseline in Salivary Flow (Unstimulated)
Time frame: Up to Week 24
Change From Baseline in Salivary Flow (Stimulated)
Time frame: Up to Week 24
Change From Baseline in Lacrimal Flow (Schirmer's Test of Ocular Function)
Time frame: Up to Week 24
Change From Baseline in Van Bijsterveld Score
Time frame: Up to Week 24
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
Time frame: Up to Week 24
Change From Baseline in Patient's Global Assessment of Disease Activity Numeric Rating Scales
Time frame: Up to Week 24
Change From Baseline in Physician's Global Assessment of Disease Activity Numeric Rating Scales
Time frame: Up to Week 24
Change from Baseline in anti-Sjogrens-syndrome-related antigen A (anti-SSA)
Time frame: Up to Week 24
Change from Baseline in anti-Sjogrens-syndrome-related antigen B (anti-SSB)
Time frame: Up to Week 24
Change from Baseline in antinuclear antibody (ANA)
Time frame: Up to Week 24
Change from Baseline in rheumatoid factor (RF)
Time frame: Up to Week 24
Change from Baseline in high-sensitivity C-reactive protein (hsCRP)
Time frame: Up to Week 24
Change from Baseline in immunoglobulin M (IgM)
Time frame: Up to Week 24
Change from Baseline in immunoglobulin M (IgG)
Time frame: Up to Week 24
Change from Baseline in immunoglobulin A (IgA)
Time frame: Up to Week 24
Change from Baseline in Serum-Free Light Chains
Time frame: Up to Week 24
Change from Baseline in Serum C3
Time frame: Up to Week 24
Change from Baseline in Serum C4
Time frame: Up to Week 24
Change from Baseline in Haemolytic Complement CH50
Time frame: Up to Week 24
Change From Baseline in Focus Score of Sublabial Salivary Gland Biopsy (In Participants With a Screening and Week 24 Biopsy)
Time frame: Week 24
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
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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.
AbbVie Inc. study director
AbbVie
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 Ravaglimab and Ravagalimab in people with Sjogren's Syndrome (SS), run by AbbVie 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 4 inclusion and 2 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: withdrawn, as of the sponsor's last update on 1 Feb 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) (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 1 Feb 2022.