Rheumatoid ArthritisPhase 1NCT06087406
A Phase 1b Study of Imvotamab in Moderate to Severe Rheumatoid Arthritis
A Phase 1 study testing Imvotamab in people with Rheumatoid Arthritis and Arthritis, Rheumatoid, run by IGM Biosciences, Inc. at 18 sites in 2 countries.
Trial summary
The purpose of this study is to determine the safety and tolerability of imvotamab in patients with moderate to severe rheumatoid arthritis who have failed prior therapies. Participants will be given imvotamab or placebo through a vein (i.e., intravenously). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Arthritis, Rheumatoid, Arthritis
- What is being tested?
- Imvotamab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 18 sitesin 2 countries
- Study dates
- 15 Mar 2023to 10 Feb 2025
- Phase
- Phase 1
- 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
- Age ≥ 18 years at the time of signing ICF
- Documented diagnosis of RA and meeting the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA at least 1 year prior to screening
- Have had treatment with bDMARDs and/or tsDMARD and were refractory by 1 of 2 reasons:
- Lack of benefit to at least 2 bDMARDs in different mechanism classes or 1 bDMARD and 1 tsDMARD, after at least 12 weeks of treatment, in the opinion of the investigator. Lack of benefit may include inadequate improvement in joint counts, physical function, or disease activity.
- Intolerance to at least 2 bDMARDs in different mechanism classes or 1 bDMARD and 1 tsDMARD.
- Minimum of 6 swollen (SJC) and 6 tender joints (TJC) on a 66/68 joint count at the screening and baseline visit (SJC/TJC)
Show all 9Show fewer
- Central lab results for hsCRP ≥ 0.8 mg/dL
- Anti-citrullinated protein antibodies (ACPA) positive and/or rheumatoid factor (RF) positive
- If using oral corticosteroids (OCS), must be on a stable dose equivalent to ≤ 10 mg/day of prednisone for at least 2 weeks prior to first study treatment
Who cannot join
- History of a rheumatologic autoimmune disease other than RA (except secondary Sjögren's syndrome), or with significant systemic involvement secondary to RA (vasculitis, pulmonary fibrosis, or Felty's syndrome); Juvenile idiopathic arthritis (JIA) or idiopathic arthritis diagnosed before the age of 16 years; Psoriatic Arthritis; Axial spondylarthritis or any other disease associated with inflammatory arthritis; Active fibromyalgia with pain symptoms or signs that would interfere with clinical assessments for RA
- Receipt of an investigational therapy less than 3 months or 5 drug-elimination half-lives (whichever is longer) prior to first administration of study treatment and during the study
- Receipt of any of the following excluded RA therapies:
- Any cell depleting therapy, anti-CD4, anti-CD5, anti-CD3, rituximab, ocrelizumab, or ofatumumab, less than 6 months prior to first administration of study treatment.
- Have received prior tsDMARds including but not limited to inhibitors of Janus kinase (JAK), Bruton tyrosine kinase, or tyrosine kinase 2, including baricitinib, tofacitinib, upadacitinib, filgotinib, ibrutinib, or fenebrutinib, or any investigational agent less than 3 months or 5 half-lives, whichever is longer, prior to first administration of study treatment
- Have received prior immunomodulatory bDMARDs for RA including, but not limited to adalimumab, golimumab, ustekinumab, secukinumab, tocilizumab, abatacept, or other inhibitors of TNF, IL-6, IL-23, or IL-17 less than 3 months or 5 half-lives, whichever is longer, prior to first administration of the study treatment
- Requiring therapy with prednisone > 10 mg/day (or equivalent dose) within 2 weeks prior to first study treatment
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
United States10 sites
University of Colorado Hopsital - Anschutz Medical Campus
Aurora, Colorado, 80045
Arthritis and Rheumatic Disease Specialties
Aventura, Florida, 33180
Arizona Arthritis & Rheumatology Research, PLLC
Flagstaff, Arizona, 860001
Arizona Arthritis & Rheumatology Research, PLLC
Glendale, Arizona, 85306
Southwest Rheumatology Research
Mesquite, Texas, 75150
Omega Research MetroWest
Orlando, Florida, 32855
Integral Rheumatology & Immunology Specialists
Plantation, Florida, 33324
Accelacare - Salisbury
Salisbury, North Carolina, 28144
Triwest Research Associates
San Diego, California, 92108
East Bay Rheumatology Medical Group
San Leandro, California, 94578
Poland8 sites
Centrum Reumatologii i Rehabilitacji NOVA REUMA
Bialystok, Podlaskie Voivodeship
Nova Reuma Domyslawska i Rusilowicz Spólka Partnerska Lekarza Reumatologa i Fizjoterapeuty
Bialystok
Medicover Integrated Clinical Services (MCIS) Centrum Medyczne Bydgoszcz
Bydgoszcz
Niepubliczny Zakład Opieki Zdrowotnej Lecznica MAK-MED w Nadarzynie
Nadarzyn
Med Polonia Sp. z o. o. - Obornicka
Poznan
Medyczne Centrum Hetmanska
Poznan
Prywatna Praktyka Lekarska Prof. Dr Hab. Med. Paweł Hrycaj
Poznan
Reumedika s.c. Wiesława i Łukasz Porawscy
Poznan
About this study
Official title: A Phase 1b, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Imvotamab in Participants With Moderate to Severe Rheumatoid Arthritis Who Have Failed Prior Therapies
The purpose of this study is to determine the safety and tolerability of imvotamab in patients with moderate to severe rheumatoid arthritis who have failed prior therapies.
Participants will be given imvotamab or placebo through a vein (i.e., intravenously). A placebo is a look-alike substance that contains no active drug
Read the detailed description
This is a Phase 1b, randomized, placebo-controlled, multicenter study to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of imvotamab in adult participants with active RA who are refractory or intolerant to 2 previous biologic disease-modifying anti-rheumatic drugs (bDMARD) or targeted synthetic disease-modifying anti-rheumatic drugs (tsDMARD) therapies. Approximately 40 participants will be sequentially assigned to different dose escalation cohorts.
- Conditions
- Rheumatoid Arthritis, Arthritis, Rheumatoid, Arthritis
- Being tested
- Imvotamab, Placebo
- Keywords
- Arthritis, Moderate to severe arthritis, active rheumatoid arthritis, bDMARD, tsDMARD, refractory
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImvotamabDrug
Administered intravenously
PlaceboDrug
0.9% sodium chloride administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Imvotamab (Dose Escalation) | Experimental | Imvotatmab administered intravenously Receives: Drug: Imvotamab |
| PBO IV | Placebo comparator | Placebo administered intravenously Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of imvotamab in participants with moderate to severe rheumatoid arthritis
Incidence of adverse events (AEs), serious adverse events (SAEs), including serious infectious events (SIEs) and opportunistic infections (OIs)
Measured: Up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start15 Mar 2023
- Primary completion10 Feb 2025
- Study completion10 Feb 2025
Why it stopped: Interim data from the Phase 1b studies of imvotamab in rheumatoid arthritis demonstrated that the depth and consistency in B Cell depletion required to measure success was insufficient.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- IGM Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Humke, MD, Study director, IGM Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087406
- Sponsor's protocol ID
- IGM-2323-102
- Status last verified
- Jan 2025
- First submitted
- 11 Oct 2023
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Imvotamab in Participants With Moderate to Severe Rheumatoid Arthritis Who Have Failed Prior Therapies
- ClinicalTrials.gov ID
- NCT06087406
- Acronym / sponsor ID
- IGM-2323-102
- Conditions
- Rheumatoid Arthritis, Arthritis, Rheumatoid, Arthritis
- Keywords
- Arthritis, Moderate to severe arthritis, active rheumatoid arthritis, bDMARD, tsDMARD, refractory
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim data from the Phase 1b studies of imvotamab in rheumatoid arthritis demonstrated that the depth and consistency in B Cell depletion required to measure success was insufficient.
- Enrolment
- 33 participants (actual)
- Lead sponsor
- IGM Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 10 Feb 2025 (actual)
- Study completion
- 10 Feb 2025 (actual)
- First posted
- 17 Oct 2023 (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 purpose of this study is to determine the safety and tolerability of imvotamab in patients with moderate to severe rheumatoid arthritis who have failed prior therapies.
Participants will be given imvotamab or placebo through a vein (i.e., intravenously). A placebo is a look-alike substance that contains no active drug
Detailed description
This is a Phase 1b, randomized, placebo-controlled, multicenter study to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of imvotamab in adult participants with active RA who are refractory or intolerant to 2 previous biologic disease-modifying anti-rheumatic drugs (bDMARD) or targeted synthetic disease-modifying anti-rheumatic drugs (tsDMARD) therapies. Approximately 40 participants will be sequentially assigned to different dose escalation cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imvotamab (Dose Escalation) | Experimental | Drug: ImvotamabImvotatmab administered intravenously |
| PBO IV | Placebo comparator | Drug: PlaceboPlacebo administered intravenously |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years at the time of signing ICF
- Documented diagnosis of RA and meeting the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA at least 1 year prior to screening
- Have had treatment with bDMARDs and/or tsDMARD and were refractory by 1 of 2 reasons:
- Minimum of 6 swollen (SJC) and 6 tender joints (TJC) on a 66/68 joint count at the screening and baseline visit (SJC/TJC)
- Central lab results for hsCRP ≥ 0.8 mg/dL
Key exclusion criteria (7 listed)
- History of a rheumatologic autoimmune disease other than RA (except secondary Sjögren's syndrome), or with significant systemic involvement secondary to RA (vasculitis, pulmonary fibrosis, or Felty's syndrome); Juvenile idiopathic arthritis (JIA) or idiopathic arthritis diagnosed before the age of 16 years; Psoriatic Arthritis; Axial spondylarthritis or any other disease associated with inflammatory arthritis; Active fibromyalgia with pain symptoms or signs that would interfere with clinical assessments for RA
- Receipt of an investigational therapy less than 3 months or 5 drug-elimination half-lives (whichever is longer) prior to first administration of study treatment and during the study
- Receipt of any of the following excluded RA therapies:
- Requiring therapy with prednisone > 10 mg/day (or equivalent dose) within 2 weeks prior to first study treatment
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 |
|---|---|---|
| ImvotamabAdministered intravenously | Drug | Imvotamab (Dose Escalation) |
| Placebo0.9% sodium chloride administered intravenously | Drug | PBO IV |
Primary outcome
To evaluate the safety and tolerability of imvotamab in participants with moderate to severe rheumatoid arthritis
Time frame: Up to Week 52
Incidence of adverse events (AEs), serious adverse events (SAEs), including serious infectious events (SIEs) and opportunistic infections (OIs)
Results and safety
The study was stopped early (reason given: Interim data from the Phase 1b studies of imvotamab in rheumatoid arthritis demonstrated that the depth and consistency in B Cell depletion required to measure success was insufficient.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
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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.
Eric Humke, MD study director
IGM Biosciences
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Imvotamab in people with Rheumatoid Arthritis and Arthritis, Rheumatoid, run by IGM Biosciences, Inc. at 18 sites in 2 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 7 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: stopped early, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Poland. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 stopped early (reason given: Interim data from the Phase 1b studies of imvotamab in rheumatoid arthritis demonstrated that the depth and consistency in B Cell depletion required to measure success was insufficient.). Results are not available in the source record.
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?
To evaluate the safety and tolerability of imvotamab in participants with moderate to severe rheumatoid arthritis (time frame: Up to Week 52). 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 18 Feb 2025.