Still´s DiseasePhase 2NCT07203001
A Phase II Trial to Evaluate the Clinical Efficacy, Safety and Tolerability of MAS825 in Pediatric and Adult Participants With Still's Disease
A Phase 2 study testing MAS825 in people with Still´s Disease, run by Novartis Pharmaceuticals at 23 sites in 8 countries.
Trial summary
The study is a phase II trial designed to evaluate the clinical efficacy, safety, and tolerability of MAS825 (arumakimig) in pediatric and adult participants with Still's disease Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Still´s Disease
- What is being tested?
- MAS825
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 23 sitesin 8 countries
- Study dates
- 3 Nov 2025to 17 May 2028
- Phase
- Phase 2
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 1 with a diagnosis of Still's Disease
- Active diseases defined as:
- CRP or ferritin levels greater than ULN, and any of:
- Fever ≥ 38°C attributed to Still's Disease activity and documented for a number of days prior to Day 1 or
- Rash attributed to Still's Disease activity or
- Musculoskeletal involvement: arthritis in a number of joints per ACP criteria for active joint or
Show all 9Show fewer
- Serositis or
- Macrophage activation syndrome activity as defined by ferritin levels and at least one of: platelet count, a biomarker or fibrinogen levels attributed to Still's Disease activity by the investigator
- Intolerance or inadequate response to available biologic therapy
Who cannot join
- Patients out of weight range
- Ongoing or previous treatment with immunomodulatory drugs
- A limited number of Still's Disease patients that have previously received MAS825 through a managed access program are permitted on the study
- Glucocorticoid dose exceeding a set limit
- Any conditions or significant medical problems which places the patient at unacceptable risk for MAS825 therapy
- Still's disease patients with evidence of macrophage activation syndrome are permitted in the study
Show all 14Show fewer
- Still's Disease patients with evidence of interstitial lung disease including those requiring supplemental oxygen therapy are permitted in the study
- History of ongoing, chronic or possibly recurrent infection (e.g. HIV, TB, HCV, HBV) and/or symptoms and signs of clinically significant active bacterial, fungal or viral infections
- Live vaccinations within a set time prior to MAS825 treatment. Live vaccines are prohibited up to several months following the last dose
- History of malignancy of any organ system, including post-transplant lymphoproliferative disorder, treated or untreated, within a number of years, regardless of whether there is evidence of local recurrence and metastases
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes or to any of the excipients
- Pregnant or breastfeeding women
- Women of child-bearing potential who do not agree to comply with required contraceptive use
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
23 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
23 sites in 8 countries
France6 sites, 6 recruiting
- Recruiting
Novartis Investigative Site
Bordeaux, 33076
- Recruiting
Novartis Investigative Site
Bron, 69677
- Recruiting
Novartis Investigative Site
Le Kremlin-Bicêtre, 94275
- Recruiting
Novartis Investigative Site
Lille, 59037
- Recruiting
Novartis Investigative Site
Paris, 75015
- Recruiting
Novartis Investigative Site
Paris, 75970
United States3 sites, 2 recruiting
- Active, not recruiting
Cincinnati Childrens Hospital
Cincinnati, Ohio, 45229
- Recruiting
Legacy Emanuel Research Hosp Portland
Portland, Oregon, 97232
Brenna Bogle, +1 503 413 5447, bbogle@lhs.org
Daniel Joseph Kingsbury
- Recruiting
University of Utah
Salt Lake City, Utah, 84113
Tressie Rollins, +1 415 515 8212, tressie.rollins@hsc.utah.edu
Aimee Ogden Hersh
Germany3 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
Heidelberg, 69120
- Recruiting
Novartis Investigative Site
Münster, 48149
- Recruiting
Novartis Investigative Site
Sankt Augustin, North Rhine-Westphalia, 53757
Italy3 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
Florence, FI, 50139
- Recruiting
Novartis Investigative Site
Genova, GE, 16147
- Recruiting
Novartis Investigative Site
Roma, RM, 00165
Spain3 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
Esplugues, Barcelona, 08950
- Recruiting
Novartis Investigative Site
Madrid, 28046
- Recruiting
Novartis Investigative Site
Valencia, 46026
Canada2 sites
- Withdrawn
Novartis Investigative Site
Montreal, Quebec, H3T 1C5
- Withdrawn
Novartis Investigative Site
Montreal, Quebec, H4A 3J1
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Ankara, Sihhiye Altindag, 06230
- Recruiting
Novartis Investigative Site
Istanbul, Fatih, 34098
Netherlands1 site
- Active, not recruiting
Novartis Investigative Site
Utrecht, 3584 CX
About this study
Official title: An Open-label Phase II Trial to Evaluate the Clinical Efficacy, Safety and Tolerability of MAS825 in Pediatric and Adult Participants With Still's Disease
The study is a phase II trial designed to evaluate the clinical efficacy, safety, and tolerability of MAS825 (arumakimig) in pediatric and adult participants with Still's disease
Read the detailed description
This is a multicenter, open-label, single-arm study to assess clinical efficacy, safety and tolerability of MAS825 in participants (both pediatric and adult) with Still's disease who have had inadequate response to IL-1 and/or IL-6 or other available therapies. Participants with associated lung disease and/or macrophage activation syndrome may also be included.
This study has three periods (Screening, Treatment Period 1, and Treatment Period 2) and a total duration of approximately 16 months.
- Conditions
- Still´s Disease
- Being tested
- MAS825
- Keywords
- Still´s disease, pediatric, adult, sJIA, AOSD, Systemic Juvenile Idiopathic Arthritis, Adult Onset Still s disease, rheumatology, MAS825, arumakimig
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAS825Drug
Also called Arumakimig
Experimental drug
| Study group | Role | What they receive |
|---|---|---|
| MAS825 | Experimental | Experimental drug Receives: Drug: MAS825 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with clinical response based on one set of response criteria
Established measure for efficacy of treatments in the rheumatologic conditions taking into account self-assessment, function and survival.
Measured: Day 85
Secondary outcomes (6)
Number of participants with clinical response based on another set of response criteria
Established measure for efficacy of treatments in the rheumatologic conditions taking into account self-assessment, function and survival.
Measured: Day 85
Response based on a biomarker level
To evaluate the efficacy of MAS825 in reducing clinical disease activity
Measured: Baseline, Day 85
Change in physician assessment based on laboratory features of MAS825
To assess the effect of MAS825 on macrophage activation syndrome
Measured: Baseline, 15 months
Change from baseline in Glucocorticoid (GC) dose
To evaluate the efficacy of MAS825 as a glucocorticoid-sparing agent
Measured: Baseline, Day 85, Month 6, Month 12
Change from baseline in patient/parent assessment of physical function as assessed by Quality of Life instrument
To evaluate the efficacy of MAS825 in improving participant's quality of life
Measured: Baseline, Day 85
Clinically inactive disease whilst on non-treatment dose corticosteroid at any time during the study
The number of participants with inactive disease will be assessed. Disease activity will be evaluated by the investigator based on physical examination and laboratory parameters.
Inactive disease is defined according to protocol-specific criteria, which include clinical signs, laboratory values, and physician assessment.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start3 Nov 2025
- Primary completion22 Apr 2027 (estimated)
- Study completion17 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Still´s DiseaseStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203001
- Sponsor's protocol ID
- CMAS825J12201
- Other IDs
- 2024-520208-25-00
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Phase II Trial to Evaluate the Clinical Efficacy, Safety and Tolerability of MAS825 in Pediatric and Adult Participants With Still's Disease
- ClinicalTrials.gov ID
- NCT07203001
- Acronym / sponsor ID
- CMAS825J12201
- Conditions
- Still´s Disease
- Keywords
- Still´s disease, pediatric, adult, sJIA, AOSD, Systemic Juvenile Idiopathic Arthritis, Adult Onset Still s disease, rheumatology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- 22 Apr 2027 (estimated)
- Study completion
- 17 May 2028 (estimated)
- First posted
- 2 Oct 2025 (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 study is a phase II trial designed to evaluate the clinical efficacy, safety, and tolerability of MAS825 (arumakimig) in pediatric and adult participants with Still's disease
Detailed description
This is a multicenter, open-label, single-arm study to assess clinical efficacy, safety and tolerability of MAS825 in participants (both pediatric and adult) with Still's disease who have had inadequate response to IL-1 and/or IL-6 or other available therapies. Participants with associated lung disease and/or macrophage activation syndrome may also be included.
This study has three periods (Screening, Treatment Period 1, and Treatment Period 2) and a total duration of approximately 16 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MAS825 | Experimental | Drug: MAS825Experimental drug |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 1 with a diagnosis of Still's Disease
- Active diseases defined as:
- CRP or ferritin levels greater than ULN, and any of:
- Intolerance or inadequate response to available biologic therapy
Key exclusion criteria (14 listed)
- Patients out of weight range
- Ongoing or previous treatment with immunomodulatory drugs
- Glucocorticoid dose exceeding a set limit
- Any conditions or significant medical problems which places the patient at unacceptable risk for MAS825 therapy
- History of ongoing, chronic or possibly recurrent infection (e.g. HIV, TB, HCV, HBV) and/or symptoms and signs of clinically significant active bacterial, fungal or viral infections
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 |
|---|---|---|
| MAS825Also: ArumakimigExperimental drug | Drug | MAS825 |
Primary outcome
Number of participants with clinical response based on one set of response criteria
Time frame: Day 85
Established measure for efficacy of treatments in the rheumatologic conditions taking into account self-assessment, function and survival.
6 secondary outcomes
Number of participants with clinical response based on another set of response criteria
Time frame: Day 85
Response based on a biomarker level
Time frame: Baseline, Day 85
Change in physician assessment based on laboratory features of MAS825
Time frame: Baseline, 15 months
Change from baseline in Glucocorticoid (GC) dose
Time frame: Baseline, Day 85, Month 6, Month 12
Change from baseline in patient/parent assessment of physical function as assessed by Quality of Life instrument
Time frame: Baseline, Day 85
Clinically inactive disease whilst on non-treatment dose corticosteroid at any time during the study
Time frame: 15 months
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 25 Sep 2026.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Related trials for Still´s Disease
Active, not recruitingObservational study
A Study of Firsekibart Versus Anakinra in Adult-Onset Still's Disease
Still's Disease, Adult-Onset
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.
Novartis Pharmaceuticals contact
23 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MAS825 in people with Still´s Disease, run by Novartis Pharmaceuticals at 23 sites in 8 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 9 inclusion and 14 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 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in France, United States, Germany, Italy, Spain and 3 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. 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?
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 Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with clinical response based on one set of response criteria (time frame: Day 85). 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 25 Sep 2026.