Active Rheumatoid ArthritisPhase 2NCT07409103
A Study to Assess the Safety and Efficacy of Different Doses of ELV001 to Treat Active Rheumatoid Arthritis in Patients With an Inadequate Response to Methotrexate and Tumor Necrosis Factor Inhibition (START SYNERGY)
A Phase 2 study testing ELV001 25 mg, ELV001 75 mg and ELV001 125 mg in people with Active Rheumatoid Arthritis, run by Elevara Medicines Limited at 34 sites in 3 countries.
Trial summary
This is a Phase 2 randomized, double-blind, placebo-controlled study with a total duration of 32 weeks from Screening to End-of-Study (EOS) Visit. Approximately 180 participants are planned to be enrolled. The number of participants can be extended to maximally 220 to account for dropouts during the study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Active Rheumatoid Arthritis
- What is being tested?
- ELV001 25 mg, ELV001 75 mg and ELV001 125 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 34 sitesin 3 countries
- Study dates
- 18 Feb 2026to 31 Mar 2028
- Phase
- Phase 2
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
- Provided written informed consent to participate to the study and are able and willing to adhere to the study protocol.
- Male or female, 18 to 75 years of age, at the time of signing the informed consent.
- Body mass index (BMI) between 18.5 and 32.0 kg/m2 and minimum weight of 50 kg at the Screening Visit.
- Have a diagnosis of adult onset RA and fulfill the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria (Aletaha et al. 2010) for at least 6 months prior to Screening.
- Have active RA defined by a DAS28-CRP ≥ 3.2 and the presence of ≥ 3 swollen joints (based on 66 joint count) and ≥ 3 tender joints (based on 68 joint count) at Screening and Baseline. The distal interphalangeal joint should be evaluated but not included in the total count to determine eligibility.
- Have C-reactive protein (CRP) ≥ upper limit of normal (ULN) at Screening.
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- Have adequate hematologic function at Screening AND at Baseline.
- Have adequate liver and renal function at Screening.
- Are currently treated with MTX (methotrexate) with folic acid supplementation according to local standard-of-care. The maximum dose of MTX is 25 mg/week for oral use and 20 mg/week for parenteral use. The minimum dose is 15 mg/week, except in case of intolerance or side effects when doses of 7.5 mg/week or above are acceptable. MTX should have been used for at least 6 months, of which at least 3 months at a stable dose.
- Are currently treated with a TNFi for at least 6 months, of which at least 3 months at a stable dose. Participants should have demonstrated a partial response to the TNFi, as evidenced by the Investigator or treating physician based on DAS28-CRP, SDAI, CDAI or any other measure of disease activity as per local treatment guidelines.
- The following therapies for RA are permitted during the study, if the dose is stable for ≥ 4 weeks prior to Screening: hydroxychloroquine up to 400 mg/day, oral prednisone ≤ 7.5 mg daily or equivalent corticosteroid dose. Prior treatment with other csDMARDs, bDMARDs, or tsDMARD is permitted as long as these treatments have been stopped at least 2 months prior to Screening, with exception of cell depleting therapies (eg, rituximab), which should have been stopped at least 12 months prior to Screening.
- Female participants of childbearing potential must:
- Have a negative serum pregnancy test at Screening and a negative urine pregnancy test within 24 hours prior to first dosing.
- Use highly effective contraception from signing the informed consent until at least 90 days after the last dosing.
- Not donate ova from signing the informed consent until at least 90 days after the last dosing.
- Male participants must use condoms and partners of childbearing potential must use highly effective contraception until at least 90 days after the last dosing. Male participants must not donate sperm until at least 90 days after the last dosing
Who cannot join
- Class IV RA according to ACR revised response criteria.
- Have been treated with more than 1 previous bDMARDs or tsDMARDs, excluding the current TNFi.
- Has a secondary non-response to the TNFi due to anti-drug antibodies, as assessed by the Investigator.
- Have a dose change of MTX or TNFi within the last 3 months before Baseline, or a dose change of hydroxychloroquine or oral prednisolone within the last 4 weeks before Baseline.
- Have oral prednisone > 7.5 mg/day equivalent or parenteral corticosteroids within the last 4 weeks before Baseline.
- Have intra-articular corticosteroids within the last 4 weeks before Baseline.
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- Had any other csDMARD, bDMARD, or immunosuppressive drug in the last 2 months.
- Had any cell depletion therapy (eg, rituximab) in the last 12 months.
- Have QT interval corrected for heart rate (QTc) using Fridericia's correction (QTcF) > 450 ms for males or QTcF > 470 ms for females either at Screening or Baseline, based on safety 12-lead electrocardiogram (ECG). Have a Screening or Baseline ECG with second- or third-degree atrioventricular block, bundle branch block, arrhythmia (but not sinus arrhythmia or supraventricular premature beats), or illegible QT interval.
- Have evidence of interstitial lung disease (ILD) based on either medical history, clinical signs and symptoms, imaging and/or lung function test, independently of the etiology of the ILD.
- Have a condition which could interfere with drug absorption including but not limited to short bowel syndrome.
- Have presence of 1 or more significant concurrent medical conditions, which could interfere with the treatment and/or the study per Investigator judgment, including but not limited to the following: poorly controlled diabetes or hypertension; chronic kidney disease stage IIIb, IV, or V; symptomatic heart failure (New York Heart Association class II, III, or IV); myocardial infarction or unstable angina pectoris within the past 12 months prior to randomization; severe chronic pulmonary disease (eg, requiring oxygen therapy); and major chronic inflammatory disease or connective tissue disease other than RA.
- Have a history of chronic alcohol abuse, IV drug abuse or illicit drug abuse within 1 year before Screening.
- Have a diagnosis or history of malignant disease, with the exceptions of basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- Have had any surgical procedure (except for minor surgery requiring local or no anesthesia and without any complications or sequelae) within 12 weeks prior to Screening, or any planned surgical procedure scheduled to occur during the study.
- Have received a Bacillus Calmette-Guerin (BCG) vaccination or BCG treatment within 12 months of Screening; or received any other live vaccine(s) (ie, live attenuated) within 3 months of Screening, or intend to receive a live vaccine during the study.
- Have had any of the following types of infection within 3 months of Screening or develops any of these infections before the randomization visit:
- Serious (requiring hospitalization, and/or parenteral antibiotic treatment),
- Opportunistic, as defined in (Winthrop et al. 2015) (note, Herpes zoster infection is considered active and ongoing until all vesicles are dry and crusted over),
- Chronic (duration of symptoms, signs, and/or treatment of 6 weeks or longer),
- Recurring (including, but not limited to herpes simplex, herpes zoster, recurring cellulitis, chronic osteomyelitis). Participants with recurrent nonserious infections such as cellulitis and uncomplicated orolabial and/or genital herpes may be enrolled at the discretion of the Investigator when deemed not to place participants at an increased risk of complications.
- Have any of the following:
- Human immunodeficiency virus (HIV) infection,
- Current infection with hepatitis B virus (HBV) (ie, positive for hepatitis B surface antigen and/or polymerase chain reaction [PCR] positive for HBV DNA),
- Current infection with hepatitis C virus (HCV) (ie, positive for HCV RNA),
- Active tuberculosis (TB).
- Have or have had latent TB infection (LTBI) that has not been treated with a complete course of appropriate therapy as defined by the World Health Organization (WHO) and/or the United States Centers for Disease Control and Prevention (CDC). Participants with LTBI who have been adequately treated are eligible for the study.
- Current or recent acute active infection (ie, participants must have had no symptoms and/or signs of confirmed or suspected infection and must have completed any appropriate anti-infective treatment within 30 days of Baseline); or fever of 100.5°F (38°C) or above at Screening or Baseline.
- Any other concurrent severe and/or uncontrolled medical, surgical or psychiatric and/or social condition which, in the view of the Investigator, could compromise the participant's safety or ability to participate in the study and make them unsuitable for participation.
- Use of other investigational medicinal products within 12 weeks or at least 5 half-lives (whichever is longer) before study drug administration.
- Women who are pregnant or breast-feeding or planning to become pregnant during the study.
Trial locations and contacts
34 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
34 sites in 3 countries
United States22 sites, 22 recruiting
- Recruiting
Accurate Clinical Management, LLC. - Accurate Clinical Research Inc (SMO/ Network)
Baytown, Texas, 77521
Dr. Sabeen Najam, MD, 281-240-1045, snajammd@accuratecliniclaresearch.com
Dr. Sabeen Najam, MD
- Recruiting
Rheumatology Associates of South Florida-Clinical Research Inc - Cliniverse Research (Network)
Boca Raton, Florida, 33486
Dr. Shawn Baca, 561-361-6547, Sbaca3394@gmail.com
Dr. Shawn Baca
- Recruiting
DJL Clinical Research PLLC (Network) cIRB
Charlotte, North Carolina, 28262
Dr. Emily Jane Box, 704-247-9179, Jane.box@djlresearch.com
Dr. Emily Jane Box
- Recruiting
Denver Arthritis Clinic
Denver, Colorado, 80230
Dr. Christopher R Antolini, MD, 303-302-7332, rantolini@dacdenver.com
Dr. Christopher R Antolini, MD
- Recruiting
Altoona Arthritis & Osteoporosis Center
Duncansville, Pennsylvania, 16635
Dr. Alan J Kivitz, MD,CPI, 814-296-6101, ajkivitz@yahoo.com
Dr. Alan J Kivitz, MD, CPI
- Recruiting
Arizona Arthritis & Rheumatology Associates
Gilbert, Arizona, 85032
Dr. Daniel Kreutz, 480-626-6652, Kreutz.Research@aaracr.com
Dr. Daniel Kreutz
- Recruiting
Arizona Arthritis & Rheumatology Associates
Glendale, Arizona, 85306
Dr. Nehad Solomon, 480-626-6652, Nehad.Soloman@azarthritis.com
Dr. Nehad Solomon
- Recruiting
Accurate Clinical Research Inc (SMO/ Network)
Houston, Texas, 77089
Dr. Philip Waller, MD, 281-240-1045, pwallermd@accurateclinicalresearch.com
Dr. Philip Waller, MD
- Recruiting
Heights Rheumatology and Aesthetics - ES Clinical Research Group Network
Jackson, Texas, 11372
Dr. Enelda M Agosto-Colon, 760-933-7274, eneida@thetrialshub.com
Dr. Enelda M Agosto-Colon
- Recruiting
Accurate Clinical Research Inc (SMO/ Network)
Lake Charles, Louisiana, 70605
Dr. Enrique A Mendez, 281-240-1045, emendezmd@accurateclinicalresearch.com
Dr. Enrique A Mendez, MD
- Recruiting
Great Lakes Center of Rheumatology
Lansing, Michigan, 48911
Dr. Joshua June, DO, 517-272-9727, Joshua.june@glcor.com
Dr. Joshua June, DO
- Recruiting
Prophase, LLC - Clinitiative Health Research (Network)
Margate, Florida, 33063
Dr. Renan Amador, 305-994-7599, ra@prophase-research.com
Dr. Renan Amador
- Recruiting
Millennium Medical Research LLC - Clinitiative Health Research (Network)
Miami, Florida, 33126
Dr. Ramon Moreda, 305-778-1042, drmoreda@millenniummedresearch.com
Dr. Ramon Moreda
- Recruiting
Floridian Clinical Research, LLC - Clinitiative Health Research (Network)
Miami Beach, Florida, 33016
Dr. Christopher Mesa, 305-330-9977, cmesamd@floridiancr.com
Dr. Christopher Mesa
- Recruiting
Epic Medical Research-Red Oak
Red Oak, Texas, 78666
Dr. Sunny Patel, MD, 972-777-6956, spatel@epicmedresearch.com
Dr. Sunny Patel, MD
- Recruiting
Bioresearch Partner - Cliniverse Research (Network)
South Miami, Florida, 33143
Dr. Olga Kromo, MD, 833-489-4968, okromomd@biresearchpartner.com
Dr. Olga Kromo, MD
- Recruiting
DM Clinical Research (Network)
Tomball, Texas, 77375
Dr. Shaikh Arif Ali, MD, 281-517-0550, drali@dmclinical.com
Dr. Shaikh Arif Ali, MD
- Recruiting
DM Clinical Research (Network)
Tomball, Texas, 77377
Dr. Qaiser Rehman, 281-517-0550, drrehman@dmclinical.com
Dr. Qaiser Rehman
- Recruiting
Arizona Arthritis & Rheumatology Associates
Tucson, Arizona, 85704
Dr. Romy Cabacungan, 480-626-6652, Cabacungan.Research@aaracr.com
Dr. Romy Cabacungan
- Recruiting
Solace Clinical Research - Populace Health (Network)
Tustin, California, 92780
Dr. Christine Kornu, MD, 480-716-7342, ckornu@solacecr.com
Dr. Christine Kornu, MD
- Recruiting
Carolina Arthritis Associates - Cliniverse Research (Network)
Wilmington, North Carolina, 28401
Dr. Mark D Harris, 910-762-1182, mharris@carolinaarthritis.com
Dr. Mark D Harris
- Recruiting
Pennsylvania Regional Center for Arthritis & Osteoporosis Research
Wyomissing, Pennsylvania, 19610
Dr. Greg Emkey, MD, 610-374-8133, gemkey@emkeyarthritis.com
Dr. Greg Emkey, MD
South Africa8 sites, 8 recruiting
- Recruiting
Netcare Umhlanga Medical Centre
Durban, KwaZulu-Natal, 4319
Dr. Asokan Niaidoo, (+27)31 566 6939, asokan@webmail.co.za
Dr. Asokan Niaidoo
- Recruiting
CRISMO Research Centre - Bertha Gxowa Hospital
Germiston, Gauteng, 1401
Dr Mpoti Belina Seboka, (+27)11 038 6814, drseboka@crismo.co.za
Dr Mpoti Belina Seboka
- Recruiting
Panorama Medical Center
Panorama, Cape Town, 7500
Dr Ingrid Clara Louw, rheumadocicl@mweb.co.za, rheumadocicl@mweb.co.za
Dr Ingrid Clara Louw
- Recruiting
The Arthritis Clinical Trial Centre
Pinelands, Capetown, 7405
Dr. Cathy Spargo, (+27)21 510 6638, spargoc@rheumatologists.co.za
Dr. Cathy Spargo
- Recruiting
Clinical Research Unit, University of Pretoria, Room 2-54, Pathology Building, Prinshof Medical Campus Dr. Savage Road, incorporating Steve Biko Hospital, Steve Biko Road
Pretoria, Gauteng, 0002
Mahmood Moosa T Mahommed Ally, Prof, (+27) 12 319 2166, mahmood.ally@up.ac.za
Mahmood Moosa T Mahommed Ally, Prof
- Recruiting
Netcare Jakaranda Hospital Suite 102
Pretoria, Gauteng, 0002
Dr. Elsa Margaretha van Duuren, (+27)12 343 0428, elsa@evduuren.co.za
Dr. Elsa Margaretha van Duuren
- Recruiting
Winelands Medical Research Centre - Somerset West (Dr Francois Bouwer INC)
Somerset West, Capetown, 7500
Dr Francois Bouwer, (+27)21 939 6106, rheumadocicl@mweb.co.za
Dr Francois Bouwer
- Recruiting
Winelands Medical Research Centre
Stellenbosch, Western Cape, 7600
Dr. Helmuth Reuter, (+27)21 882 8252, h.reuter@winelandsrheumatology.com
Dr. Helmuth Reuter
Serbia4 sites, 4 recruiting
- Recruiting
Institute of Rheumatology
Belgrade, 11000
Branko Barac, Dr, +381631112050, baracbranko3@gmail.com
Branko Barac, Dr
- Recruiting
Institute of Rheumatology
Belgrade, 11000
Slavica P Dolijanovic, Dr, +381648833062, slavicapavlovdolijanovic@gmail.com
Slavica Dolijanovic, Dr
- Recruiting
Military Medical Academy,Clinic for Rheumatology
Belgrade, 11040
Milan Petronijevic, Dr, +381641772580, milanpetronijevic@yahoo.com
Milan Petronijevic, Dr
- Recruiting
Special Hospital for Rheumatic Diseases Novi Sad
Novi Sad, Vojvodina, 21101
Ksenija Boskovic, Dr, +381695470307, boskovicksenija@gmail.com,
Ksenija Boskovic, Dr
About this study
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety and Efficacy of ELV001 as Add-on Therapy in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate and Tumor Necrosis Factor Inhibition (START SYNERGY)
This is a Phase 2 randomized, double-blind, placebo-controlled study with a total duration of 32 weeks from Screening to End-of-Study (EOS) Visit. Approximately 180 participants are planned to be enrolled. The number of participants can be extended to maximally 220 to account for dropouts during the study.
Read the detailed description
The study has 4 study arms: placebo, 25mg, 75mg and 125mg. The study includes a 4 weeks screening period, a double blind placebo controlled period (weeks 0 to 12), a treatment extension (weeks 12 to 24) and a 4 week safety follow-up.
- Conditions
- Active Rheumatoid Arthritis
- Being tested
- ELV001 25 mg, ELV001 75 mg, ELV001 125 mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELV001 25 mgDrug
25mg from week 0 to week 12 then ELV001 75mg or 125mg per day from week 12 to week 24
ELV001 75 mgDrug
75mg from week 0 to week 24
ELV001 125 mgDrug
125mg from week 0 to week 24
PlaceboDrug
Placebo from week 0 to week 12, then ELV001 75mg or 125mg per day from week 12 to week 24.
| Study group | Role | What they receive |
|---|---|---|
| ELV001 25 mg QD | Experimental | Not described Receives: Drug: ELV001 25 mg |
| ELV001 75 mg QD | Experimental | Not described Receives: Drug: ELV001 75 mg |
| ELV001 125 mg QD | Experimental | Not described Receives: Drug: ELV001 125 mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Disease activity score 28- C-reactive protein between Baseline and Week 12.
Change in Disease Activity Score (Disease activity score 28- C-reactive protein) from Baseline to Week 12, comparing placebo with the highest ELV001 dose group, Score less than 2.6 indicates disease in remission, score more than 5.1 indicates very active disease
Measured: From Baseline to week 12
Secondary outcomes (20)
Incidence and severity of TEAEs, SAEs, and AESIs.
Measured: Up to 32 weeks
Incidence and severity of SUSARs
Measured: Up to 32 weeks
Change from Baseline in 12-lead ECG parameters (including QTcF)
Measured: From baseline to week 28
Change from Baseline in vital signs (Respiratory Rate)
Respiratory Rate [breaths per minute (bpm)]
Measured: Baseline to week 28
Change from Baseline in laboratory parameters (hematology, biochemistry, coagulation, and urinalysis).'
Measured: Baseline to week 28
Percentage of participants reaching remission and low disease activity as defined by Disease activity score 28- C-reactive protein at Week 12 and at Week 24.
Measured: From Baseline to week 12 and week 24
Percentage of participants reaching ACR20/ACR50/ACR70 at Week 12 and at Week 24
Measured: From Baseline to week 12 and week 24
Change from Baseline to Week 12 and to Week24 in swollen joint count, tender joint count
66 Swollen Joint Count (SJC) and 68 Tender Joint Count (TJC): Joint Count will be assessed by an independent joint assessor, and the same assessor will be used throughout all visits of the study
Measured: From Baseline to week 12 and week 24
Change From baseline to Weeks12 and 24 in Short form health survey36,
Short form health survey36: Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning.
Measured: From Baseline to week 12 and week 24
Assessment of any correlation between dose and disease activity scores.
Measured: Baseline to week 28
Plasma drug and metabolite concentrations - area under the curve (AUC)
Pharmacokinetics - AUC
Measured: baseline to week 28
Plasma drug and metabolite concentration - maximum concentration (Cmax)
Pharmacokinetics - Cmax
Measured: baseline to week 28
Change from Baseline in vital signs (Body Temperature)
Body Temperature (Celsius)
Measured: Baseline to week 28
Change from Baseline in vital signs (Blood Pressure)
Blood Pressure: Systolic [Millimeters of mercury(mmHg)], Diastolic [Millimeters of mercury(mmHg)],
Measured: Baseline to week 28
Change from Baseline in vital signs (Heart Rate)
Heart rate (Per minute)
Measured: Baseline to week 28
Change from Baseline to Week 12 and to Week 24 in simplified disease activity index (SDAI).
Total scores ranging from 0 to 100. Higher scores indicate greater disease activity.
Measured: From Baseline to week 12 and week 24
Change from Baseline to Week 12 and to Week 24 in Clinical disease activity index (CDAI).
Total scores ranging from 0 to 76. Higher scores indicate greater disease activity.
Measured: From Baseline to week 12 and week 24
participant's global assessments: disease activity (VAS),and arthritis pain (VAS)
participant's global assessments: disease activity (VAS): Results will be expressed in millimeters measured to the crossing point on the VAS scale.
Measured: From Baseline to week 12 and week 24
Change from Baseline to Week 12 and to Week 24 in Health Assessment Questionnaire-Disability Index (HAQ-DI).
Scores for each of the 8 functional domains will be averaged to calculate the functional disability index.
Measured: From Baseline to week 12 and week 24
Functional Assessment of Chronic illness Therapy
The sum of all responses is combined to give a FACIT-Fatigue score range from 0 to 52 with higher scores indicating less fatigue.
Measured: From Baseline to week 12 and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start18 Feb 2026
- Primary completion15 Apr 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Active Rheumatoid ArthritisStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elevara Medicines Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409103
- Sponsor's protocol ID
- ELV001-201
- Status last verified
- Oct 2026
- First submitted
- 11 Dec 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No