Idiopathic Inflammatory MyositisPhase 2NCT05669014
A Phase 2 Proof of Concept Study to Evaluate the Efficacy and Safety of Daxdilimab in Participants With Dermatomyositis (DM) or Anti-synthetase Inflammatory Myositis (ASIM)
A Phase 2 study testing Daxdilimab in people with Idiopathic Inflammatory Myositis, run by Amgen at 9 sites in 6 countries.
Trial summary
The primary efficacy objective: To evaluate the effect of daxdilimab compared with placebo in reducing disease activity at Week 24. The secondary efficacy objectives include: 1. To evaluate the effect of daxdilimab compared with placebo in reducing disease activity at Week 24. 2. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Idiopathic Inflammatory Myositis
- What is being tested?
- Daxdilimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 9 sitesin 6 countries
- Study dates
- 4 Dec 2023to 2 Jul 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adult men or women 18 and ≤ 75 years of age at the time of signing the informed consent (ICF).
- A diagnosis of definite or probable myositis according to American College of Rheumatology/European League Against Rheumatism 2017 (ACR/EULAR 2017) criteria:
- Population 1: DM
- Diagnosis of DM with DM rash current or historical, or
- Population 2: ASIM
- Anti-histidyl tRNA synthetase-(Anti-Jo-1) antibodies must be positive during screening by central laboratory testing, or
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- One of following antibodies must be positive by historical testing: directed against anti-alanyl- (anti-PL-12), anti-threonyl-(anti PL-7), anti-asparaginyl-(anti-KS), anti-glycyl-(anti-EJ), anti-isoleucyl-(anti-OJ), anti-phenylalanyl-transfer RNA synthetase-(anti-ZO), anti-tyrosil-YRS(HA).
- Currently active myositis with all the following (a, b, and c) during screening:
- Manual Muscle Testing (MMT 8) score < 142
- At least 2 other abnormal core set measures (CSM) from the following list:
- Patient global disease activity (PtGDA) ≥ 2 cm in a 10 cm visual analog scale (VAS)
- Physician's Global Disease Activity (PhGDA) ≥ 2 cm in a 10 cm VAS
- Extramuscular activity ≥ 2cm in a 10 cm VAS
- At least one muscle enzyme 1.5 times upper limit of normal (ULN)
- Health assessment questionnaire-disability index (HAQ-DI) ≥ 0.5
- Global muscle damage score ≤ 5 on a 10 cm VAS on the myositis damage index (MDI).
- Participants should be on stable standard of care therapy if tolerated; if they are not able to tolerate it or have failed standard of care, medications should have a washed out period.
- Participants should be willing to taper corticosteroid dose per protocol when stable or improving.
Who cannot join
- Any condition that, in the opinion of the investigator or sponsor, would interfere with the evaluation of investigational product (IP) or interpretation of participant safety or study results.
- Weight > 160 kg (352 pounds) at screening.
- Breastfeeding or pregnant women or women who intend to become pregnant anytime from signing the ICF through 6 months after receiving the last dose of IP.
- History of clinically meaningful cardiac disease including unstable angina, myocardial infarction, congestive heart failure within 6 months prior to randomization; arrhythmia requiring active therapy, except for clinically insignificant extra systoles, or minor conduction abnormalities; or presence of clinically meaningful abnormality on electrocardiogram (ECG) if, in the opinion of the Investigator, it would increase the risk of study participation.
- History of cancer within the past 5 years except cutaneous basal cell or squamous cell carcinoma treated with curative therapy.
- Any underlying condition that in the opinion of the Investigator significantly predisposes the participant to infection (eg. hepatitis C).
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- Known history of a primary immunodeficiency or an underlying condition, such as known human immunodeficiency virus (HIV) infection, or a positive result for HIV infection per central laboratory.
- All participants will undergo testing for hepatitis B virus serology as defined in the protocol.
- Active tuberculosis (TB), or a positive interferon gamma (IFN-γ) release assay (IGRA) test at screening, unless documented history of appropriate treatment for active or latent TB according to local guidelines.
- Any severe herpes virus family infection (including Epstein-Barr virus, cytomegalovirus [CMV]) at any time prior to randomization.
- Opportunistic infection requiring hospitalization or parenteral antimicrobial treatment within 2 years prior to randomization.
- Significant organ system involvement or myositis damage (global muscle damage score > 5 on a 10 cm VAS scale on the MDI) that poses risks in the study or impedes assessments.
- Diagnosis of immune-mediated necrotizing myopathy (IMNM) [(positive 3-hydroxy-3-methylglutaryl-coenzyme A reductase (anti-HMGR), anti-signal recognition particle (anti- SRP), or antibody negative)], inclusion body myositis (IBM) (including positive anti-cytosolic 5'-nucleotidase 1A (anti cN1A), or drug-induced myositis.
- Current musculoskeletal, joint, or inflammatory disease, including significant joint contractures or calcinosis that in the opinion of the investigator, could interfere with the muscle strength assessments and confound the disease activity assessments.
- Wheelchair bound participants.
- Current inflammatory skin disease other than DM or ASIM that, in the opinion of the investigator, could interfere with the inflammatory skin assessments or confound the disease activity assessments.
- Severe interstitial lung disease where respiratory symptoms limit participant function or progressive pulmonary fibrosis.
- Myositis in overlap with another connective tissue disease that precludes the accurate assessment of a treatment response (for example, difficulty in assessing muscle strength in a scleroderma patient with associated myositis).
Trial locations and contacts
9 sites in 6 countries.
9 sites in 6 countries
Brazil2 sites
Centro Mineiro de Pesquisa - CMiP
Juiz de Fora, Minas Gerais, 36010-570
LMK Servicos Medicos SS
Porto Alegre, Rio Grande do Sul, 90480-000
Mexico2 sites
Unidad de Investigacion de las Enfermedades Reumaticas S.A. De C.V.
Mexico City
Accelerium, S. de R.L. de C.V. - PPDS
Monterrey, 64000
United Kingdom2 sites
Western General Hospital Edinburgh - PPDS
Edinburgh, Midlothian, EH4 2XU
Aintree University Hospital - NWCRN - PPDS
Liverpool, Merseyside, L9 7AL
United States1 site
Advanced Research Center, Inc.
Anaheim, California, 92805-5854
About this study
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of Daxdilimab Subcutaneous Injection in Adult Participants With Inadequately Controlled Dermatomyositis or Anti-synthetase Inflammatory Myositis.
The primary efficacy objective:
To evaluate the effect of daxdilimab compared with placebo in reducing disease activity at Week 24.
The secondary efficacy objectives include:
- To evaluate the effect of daxdilimab compared with placebo in reducing disease activity at Week 24.
- To evaluate the effect of daxdilimab compared with placebo on skin symptoms at Week 24.
- To evaluate the effect of daxdilimab on decreasing the use of corticosteroid at Week 24.
Other secondary objectives include:
- To characterize the pharmacokinetics (PK) and immunogenicity of daxdilimab in participants.
- To evaluate the safety and tolerability of daxdilimab in participants.
Read the detailed description
The study will enroll participants with 2 idiopathic inflammatory myositis populations:
- Population 1 or dermatomyositis (DM): participants with DM with definite or probable myositis according to the American College of Rheumatology/European League Against Rheumatism 2017 (ACR/EULAR 2017) criteria and a DM rash.
- Population 2 or anti-synthetase inflammatory myositis (ASIM): participants with ASIM with definite or probable myositis according to ACR/EULAR 2017 criteria and a positive ASIM associated antibody.
Participants will be randomized by population in a 1:1 ratio and receive investigational product (IP) daxdilimab or placebo by subcutaneous injection.
The estimated total study duration will be up to 36 weeks (up to 60 weeks for those participants who entered the open-label extension prior to amendment 2.)
Acquired from Horizon in 2024.
- Conditions
- Idiopathic Inflammatory Myositis
- Being tested
- Daxdilimab, Placebo
- Keywords
- Anti-synthetase syndrome, Myositis, Polymyositis
- Medical subject headings
- Myositis, Polymyositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaxdilimabDrug
Also called HZN-7734
Participants will be administered daxdilimab by subcutaneous (SC) injection.
PlaceboDrug
Participants will be administered identically matching placebo by SC injection.
| Study group | Role | What they receive |
|---|---|---|
| Daxdilimab | Experimental | Daxdilimab will be administered by subcutaneous (SC) injection during the 24-week treatment period followed by an 8-week safety follow up.
Prior to amendment 2 participants could enter an open-label extension period from weeks 24-48. For those participants already in the open-label extension, they will stop dosing and enter the safety follow up. Receives: Drug: Daxdilimab |
| Placebo | Placebo comparator | Matching placebo will be administered by SC injection during the 24-week treatment period followed by an 8-week safety follow up.
Prior to amendment 2 participants could enter an open-label extension period from weeks 24-48 and receive daxdilimab. For those participants already in the open-label extension, they will stop dosing and enter the safety follow up. Receives: Drug: Daxdilimab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Total Improvement Score (TIS) at Week 24
Total improvement score was derived from standardized clinical response criteria which was calculated by sum of improvement scores of 6 core set measures (CSMs) included physician global disease activity (PhGDA), patient global disease activity (PtGDA), manual muscle testing 8 (MMT8) bilateral, health assessment questionnaire-disability index (HAQ-DI), extramuscular global assessment (EGA), and laboratory muscle enzymes (LME). Total improvement score was ranged from 0 to 100, where higher scores indicated greater improvement. The TIS improvement categories are defined as minimal (TIS greater than or equal to [≥]20), moderate (TIS ≥40) and major improvement (TIS ≥60). Mean TIS at week 24 was reported in this outcome measure.
Measured: At Week 24
Secondary outcomes (9)
Percentage of Participants With Improvement of TIS ≥ 40 and Without Deterioration at 2 Consecutive Visits at 24 Weeks
The percentage of participants who achieved moderate improvement (TIS ≥ 40), and do not experience confirmed disease deterioration at two consecutive visits through Week 24 were reported. Confirmed deterioration is defined as any of the following occurred at two consecutive visits compared with baseline:
(i) Worsening of PhGDA by ≥ 2 cm and worsening of MMT8 by ≥ 20%, or (ii) Worsening of EGA by ≥ 2 cm, or (iii) Worsening of ≥ 3 of 5 core set measures (excluding laboratory enzymes) by ≥ 30%.
Measured: Up to Week 24
Percentage of Participants With Improvement of TIS ≥ 20 and Without Deterioration at 2 Consecutive Visits at 24 Weeks
The percentage of participants who achieved minimal improvement (TIS ≥ 20), and do not experience confirmed disease deterioration at two consecutive visits through Week 24 were reported. Confirmed deterioration is defined as any of the following occurred at two consecutive visits compared with baseline:
(i) Worsening of PhGDA by ≥ 2 cm and worsening of MMT8 by ≥ 20%, or (ii) Worsening of EGA by ≥ 2 cm, or (iii) Worsening of ≥ 3 of 5 core set measures (excluding laboratory enzymes) by ≥ 30%.
Measured: Up to Week 24
Change in the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Activity Score From Baseline (Day 1) to Week 24
The CDASI activity score used to assess the severity of cutaneous DM and detect the improvement in disease activity. The CDASI activity score evaluates erythema, scale, and erosion/ulceration across 15 different body areas including the presence and severity of Gottron's papules on the hands, periungual changes and alopecia. The CDASI activity score ranges from 0 to 100 and higher scores indicate greater disease severity. A negative change from baseline indicates a reduction in disease severity.
Measured: From Baseline (Day 1) to Week 24
Percentage of Participants With Clinically Meaningful Oral Corticosteroid (OCS) Reduction at Week 24
The percentage of participants who received OCS dose ≥ 10 milligram per day (mg/day) of prednisone or equivalent at baseline and who achieved a clinically meaningful reduction in oral corticosteroid dose either: a 25% reduction or an OCS dose of 7.5 mg/day of prednisone or equivalent at Week 24 were reported.
Measured: Up to Week 24
Serum Concentration of Daxdilimab During Stage I
Mean concentrations of DAX were reported. Values below the lower limit of quantitation (LLOQ) were set to zero before calculation of the descriptive statistics. If the calculated mean concentration from observed values was less than the LLOQ of the assay, the mean value was set to " below the limit of quantification (BLQ)".
Measured: Stage I: Day 1 (predose and 2 hours postdose), predose on Weeks 4, 8, 12, 16, and any time on Week 24
Serum Concentration of Daxdilimab During Stage II
Mean concentrations of DAX were reported. Values below the lower limit of quantitation (LLOQ) were set to zero before calculation of the descriptive statistics.
Measured: Stage II: Predose on Week 36 and Week 48
Number of Participants Who Developed Anti-drug Antibodies (ADA)
Number of participants who developed ADAs were reported. The ADA status was summarized by the categories included; ADA prevalence: ADA positive observed at least once during the trial (baseline included); Only baseline positive: ADA positive observed at baseline but not observed at any post-baseline; Only post-baseline positive (treatment-induced): ADA positive not observed at baseline but observed at least once post-baseline; Both baseline and post-baseline positive: ADA positive observed at both baseline and at least once post-baseline; Incidence (treatment emergent ADA): ADA positive post-baseline only or boosted their pre-existing ADA titer (≥ 4-fold increase) during the trial period.
Measured: Up to Week 56
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious AEs (TESAEs), and Treatment-emergent AEs of Special Interest (TEAESIs) During Stage I
An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of trial intervention, whether or not considered related to the trial intervention. If an AE occurs on or after the first dose of trial intervention, the AE was considered as a TEAE. An SAE is defined as any untoward medical occurrence that, at any dose results in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect. An AESI is an AE of scientific or medical concern specific to the trial intervention that requires ongoing monitoring and prompt communication by the investigator. AESIs in this trial were hypersensitivity reaction, including anaphylaxis, herpes zoster infection, severe viral infection/reactivation (CTCAE Grade 3 or higher), opportunistic infection, and malignancy (except non-melanoma skin cancer).
Measured: From first dose of trial intervention in stage I, to first dose of trial intervention in stage II or study end for non-stage II participants; median (min, max) duration was 24 (3, 34) weeks
Number of Participants Who Experienced TEAEs, TESAEs, and TEAESIs During Stage II
An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of trial intervention, whether or not considered related to the trial intervention. If an AE occurs on or after the first dose of trial intervention, the AE was considered as a TEAE. An SAE is defined as any untoward medical occurrence that, at any dose results in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect. An AESI is an AE of scientific or medical concern specific to the trial intervention that requires ongoing monitoring and prompt communication by the investigator. AESIs in this trial were hypersensitivity reaction, including anaphylaxis, herpes zoster infection, severe viral infection/reactivation (CTCAE Grade 3 or higher), opportunistic infection, and malignancy (except non-melanoma skin cancer).
Measured: From first dose of trial intervention in stage II to study end; median (min, max) duration was 24 (18, 33) weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2022
- Study start4 Dec 2023
- Primary completion2 Jul 2025
- Study completion2 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Idiopathic Inflammatory MyositisStudies of the same condition, open and under way.
- More trials run by AmgenThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05669014
- Sponsor's protocol ID
- HZNP-DAX-205
- Other IDs
- 2022-502810-10-00
- Status last verified
- Jul 2026
- First submitted
- 20 Dec 2022
- Last updated
- 25 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of Daxdilimab Subcutaneous Injection in Adult Participants With Inadequately Controlled Dermatomyositis or Anti-synthetase Inflammatory Myositis.
- ClinicalTrials.gov ID
- NCT05669014
- Acronym / sponsor ID
- HZNP-DAX-205
- Conditions
- Idiopathic Inflammatory Myositis
- Keywords
- Anti-synthetase syndrome, Myositis, Polymyositis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 2 Jul 2025 (actual)
- Study completion
- 2 Jul 2025 (actual)
- First posted
- 30 Dec 2022 (actual)
- Results
- Posted 25 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary efficacy objective:
To evaluate the effect of daxdilimab compared with placebo in reducing disease activity at Week 24.
The secondary efficacy objectives include:
- To evaluate the effect of daxdilimab compared with placebo in reducing disease activity at Week 24.
- To evaluate the effect of daxdilimab compared with placebo on skin symptoms at Week 24.
- To evaluate the effect of daxdilimab on decreasing the use of corticosteroid at Week 24.
Other secondary objectives include:
- To characterize the pharmacokinetics (PK) and immunogenicity of daxdilimab in participants.
- To evaluate the safety and tolerability of daxdilimab in participants.
Detailed description
The study will enroll participants with 2 idiopathic inflammatory myositis populations:
- Population 1 or dermatomyositis (DM): participants with DM with definite or probable myositis according to the American College of Rheumatology/European League Against Rheumatism 2017 (ACR/EULAR 2017) criteria and a DM rash.
- Population 2 or anti-synthetase inflammatory myositis (ASIM): participants with ASIM with definite or probable myositis according to ACR/EULAR 2017 criteria and a positive ASIM associated antibody.
Participants will be randomized by population in a 1:1 ratio and receive investigational product (IP) daxdilimab or placebo by subcutaneous injection.
The estimated total study duration will be up to 36 weeks (up to 60 weeks for those participants who entered the open-label extension prior to amendment 2.)
Acquired from Horizon in 2024.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daxdilimab | Experimental | Drug: DaxdilimabDaxdilimab will be administered by subcutaneous (SC) injection during the 24-week treatment period followed by an 8-week safety follow up. Prior to amendment 2 participants could enter an open-label extension period from weeks 24-48. For those participants already in the open-label extension, they will stop dosing and enter the safety follow up. |
| Placebo | Placebo comparator | Drug: Daxdilimab, Drug: PlaceboMatching placebo will be administered by SC injection during the 24-week treatment period followed by an 8-week safety follow up. Prior to amendment 2 participants could enter an open-label extension period from weeks 24-48 and receive daxdilimab. For those participants already in the open-label extension, they will stop dosing and enter the safety follow up. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Adult men or women 18 and ≤ 75 years of age at the time of signing the informed consent (ICF).
- A diagnosis of definite or probable myositis according to American College of Rheumatology/European League Against Rheumatism 2017 (ACR/EULAR 2017) criteria:
- Currently active myositis with all the following (a, b, and c) during screening:
- Participants should be on stable standard of care therapy if tolerated; if they are not able to tolerate it or have failed standard of care, medications should have a washed out period.
- Participants should be willing to taper corticosteroid dose per protocol when stable or improving.
Key exclusion criteria (18 listed)
- Any condition that, in the opinion of the investigator or sponsor, would interfere with the evaluation of investigational product (IP) or interpretation of participant safety or study results.
- Weight > 160 kg (352 pounds) at screening.
- Breastfeeding or pregnant women or women who intend to become pregnant anytime from signing the ICF through 6 months after receiving the last dose of IP.
- History of clinically meaningful cardiac disease including unstable angina, myocardial infarction, congestive heart failure within 6 months prior to randomization; arrhythmia requiring active therapy, except for clinically insignificant extra systoles, or minor conduction abnormalities; or presence of clinically meaningful abnormality on electrocardiogram (ECG) if, in the opinion of the Investigator, it would increase the risk of study participation.
- History of cancer within the past 5 years except cutaneous basal cell or squamous cell carcinoma treated with curative therapy.
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 |
|---|---|---|
| DaxdilimabAlso: HZN-7734Participants will be administered daxdilimab by subcutaneous (SC) injection. | Drug | Daxdilimab, Placebo |
| PlaceboParticipants will be administered identically matching placebo by SC injection. | Drug | Placebo |
Primary outcome
Mean Total Improvement Score (TIS) at Week 24
Time frame: At Week 24
Total improvement score was derived from standardized clinical response criteria which was calculated by sum of improvement scores of 6 core set measures (CSMs) included physician global disease activity (PhGDA), patient global disease activity (PtGDA), manual muscle testing 8 (MMT8) bilateral, health assessment questionnaire-disability index (HAQ-DI), extramuscular global assessment (EGA), and laboratory muscle enzymes (LME). Total improvement score was ranged from 0 to 100, where higher scores indicated greater improvement. The TIS improvement categories are defined as minimal (TIS greater than or equal to [≥]20), moderate (TIS ≥40) and major improvement (TIS ≥60). Mean TIS at week 24 was reported in this outcome measure.
9 secondary outcomes
Percentage of Participants With Improvement of TIS ≥ 40 and Without Deterioration at 2 Consecutive Visits at 24 Weeks
Time frame: Up to Week 24
Percentage of Participants With Improvement of TIS ≥ 20 and Without Deterioration at 2 Consecutive Visits at 24 Weeks
Time frame: Up to Week 24
Change in the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Activity Score From Baseline (Day 1) to Week 24
Time frame: From Baseline (Day 1) to Week 24
Percentage of Participants With Clinically Meaningful Oral Corticosteroid (OCS) Reduction at Week 24
Time frame: Up to Week 24
Serum Concentration of Daxdilimab During Stage I
Time frame: Stage I: Day 1 (predose and 2 hours postdose), predose on Weeks 4, 8, 12, 16, and any time on Week 24
Serum Concentration of Daxdilimab During Stage II
Time frame: Stage II: Predose on Week 36 and Week 48
Number of Participants Who Developed Anti-drug Antibodies (ADA)
Time frame: Up to Week 56
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious AEs (TESAEs), and Treatment-emergent AEs of Special Interest (TEAESIs) During Stage I
Time frame: From first dose of trial intervention in stage I, to first dose of trial intervention in stage II or study end for non-stage II participants; median (min, max) duration was 24 (3, 34) weeks
Number of Participants Who Experienced TEAEs, TESAEs, and TEAESIs During Stage II
Time frame: From first dose of trial intervention in stage II to study end; median (min, max) duration was 24 (18, 33) weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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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.
MD study director
Amgen
9 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Daxdilimab in people with Idiopathic Inflammatory Myositis, run by Amgen at 9 sites in 6 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 18 inclusion and 18 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: finished, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Brazil, Mexico, United Kingdom, United States, Czechia and 1 more country. 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?
Yes. Results are posted in the registry (first posted 25 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Total Improvement Score (TIS) at Week 24 (time frame: At 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 25 Aug 2026.