A Phase 2 interventional study of Daxdilimab and Placebo in Idiopathic Inflammatory Myositis, sponsored by Amgen. Completed at 9 sites in 6 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Amgen · Phase 2, Interventional, and Treatment
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:
Other secondary objectives include:
The study will enroll participants with 2 idiopathic inflammatory myositis populations:
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.
215 studies on the registry are indexed under Myositis; 100 are open to participants now.
This study's enrollment of 12 is below the median of 30 across 141 interventional studies indexed under Myositis.
Browse Myositis studies →Amgen is the lead sponsor of 1,047 studies on the registry; 52 are open to participants now.
Of its 246 completed or terminated interventional studies of FDA-regulated products, 166 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
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
Population 2: ASIM
Currently active myositis with all the following (a, b, and c) during screening:
At least 2 other abnormal core set measures (CSM) from the following list:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Daxdilimab
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.
Drug: Daxdilimab · Drug: Placebo
Participants will be administered daxdilimab by subcutaneous (SC) injection.
Also known as: HZN-7734
Participants will be administered identically matching placebo by SC injection.
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.
Time frame: At Week 24
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%.
Time frame: 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%.
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
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.
Time frame: 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.
Time frame: 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)".
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
Mean concentrations of DAX were reported. Values below the lower limit of quantitation (LLOQ) were set to zero before calculation of the descriptive statistics.
Time frame: 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.
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
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).
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
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).
Time frame: From first dose of trial intervention in stage II to study end; median (min, max) duration was 24 (18, 33) weeks
A total of 12 participants with dermatomyositis (DM) or anti-synthetase inflammatory myositis (ASIM) were enrolled at 9 centers in Brazil, Czech Republic, Mexico, Spain, United Kingdom and United States between December 2023 and July 2025.
| Milestone | DM: Placebo/Daxdilimab (DAX) 300 Milligrams (mg) OL | DM: DAX 300 mg/DAX 300 mg OL | ASIM: DAX 300 mg/DAX 300 mg OL |
|---|---|---|---|
| Started | 4 | 5 | 3 |
| Completed | 3 | 3 | 2 |
| Not completed | 1 | 2 | 1 |
| Withdrew: Participant decision | 1 | 2 | 1 |
| Milestone | DM: Placebo/Daxdilimab (DAX) 300 Milligrams (mg) OL | DM: DAX 300 mg/DAX 300 mg OL | ASIM: DAX 300 mg/DAX 300 mg OL |
|---|---|---|---|
| Started | 3 | 3 | 2 |
| Completed | 3 | 2 | 2 |
| Not completed | 0 | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 |
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.
| Score on a scale | DM: Placebo/DAX 300 mg OL | DM: DAX 300 mg/DAX 300 mg OL | ASIM: DAX 300 mg/DAX 300 mg OL |
|---|---|---|---|
| Mean Total Improvement Score (TIS) at Week 24 | 28.75 ± 18.31 | 20.00 ± 15.21 | 61.25 ± 12.37 |
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%.
| Percentage of participants | DM: Placebo/DAX 300 mg OL | DM: DAX 300 mg/DAX 300 mg OL | ASIM: DAX 300 mg/DAX 300 mg OL |
|---|---|---|---|
| Percentage of Participants With Improvement of TIS ≥ 40 and Without Deterioration at 2 Consecutive Visits at 24 Weeks | 25.0 | 0.0 | 100.0 |
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%.
| Percentage of participants | DM: Placebo/DAX 300 mg OL | DM: DAX 300 mg/DAX 300 mg OL | ASIM: DAX 300 mg/DAX 300 mg OL |
|---|---|---|---|
| Percentage of Participants With Improvement of TIS ≥ 20 and Without Deterioration at 2 Consecutive Visits at 24 Weeks | 50.0 | 66.7 | 100.0 |
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.
| Score on a scale | DM: Placebo/DAX 300 mg OL | DM: DAX 300 mg/DAX 300 mg OL | ASIM: DAX 300 mg/DAX 300 mg OL |
|---|---|---|---|
| Change in the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Activity Score From Baseline (Day 1) to Week 24 | 3.0 ± 11.5 | -7.3 ± 6.2 | -2.5 ± 2.1 |
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.
| Percentage of participants | DM: Placebo/DAX 300 mg OL | DM: DAX 300 mg/DAX 300 mg OL | ASIM: DAX 300 mg/DAX 300 mg OL |
|---|---|---|---|
| Percentage of Participants With Clinically Meaningful Oral Corticosteroid (OCS) Reduction at Week 24 | 66.7 | 100.0 | 0.0 |
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)".
| nanograms/milliliter (ng/mL) | PK Analysis: Stage I - DM: DAX 300 mg | PK Analysis: Stage I - ASIM: DAX 300 mg |
|---|---|---|
| Day 1 Predose | NA ± NA | NA ± NA |
| Day 1 Postdose | 142.63 ± 139.78 | 323.93 ± 265.21 |
| Week 4 | 6008.00 ± 2323.70 | 5476.67 ± 2837.84 |
| Week 8 | 7320.00 ± 3487.93 | 8765.00 ± 7403.41 |
| Week 12 | 5835.00 ± 5352.80 | 10720.00 ± 7325.63 |
| Week 16 | 6255.00 ± 3709.10 | 12475.00 ± 7106.42 |
| Week 24 | 5620.00 ± 1394.74 | 11820.00 ± 8457.00 |
Mean concentrations of DAX were reported. Values below the lower limit of quantitation (LLOQ) were set to zero before calculation of the descriptive statistics.
| ng/mL | PK Analysis: Stage II - DM: Placebo/DAX 300 mg OL | PK Analysis: Stage II - DM: DAX 300 mg/DAX 300 mg OL | PK Analysis: Stage II - ASIM: DAX 300 mg/DAX 300 mg OL |
|---|---|---|---|
| Week 36 | 12970.0 ± 12670.7 | 7965.0 ± 6837.7 | 8950.0 ± 594.0 |
| Week 48 | 5524.0 ± 8381.9 | 13100.0 ± NA | 7845.0 ± 9411.6 |
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.
| Participants | DM: Placebo/DAX 300 mg OL | DM: DAX 300 mg/DAX 300 mg OL | ASIM: DAX 300 mg/DAX 300 mg OL |
|---|---|---|---|
| ADA detected (positive) on trial: ADA prevalence | 0 | 0 | 0 |
| Only baseline positive | 0 | 0 | 0 |
| Only post-baseline positive | 0 | 0 | 0 |
| Both baseline and post-baseline positive | 0 | 0 | 0 |
| Incidence (treatment-emergent ADA) | 0 | 0 | 0 |
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).
| Participants | DM: Placebo/DAX 300 mg OL | DM: DAX 300 mg/DAX 300 mg OL | ASIM: DAX 300 mg/DAX 300 mg OL |
|---|---|---|---|
| TEAEs | 3 | 4 | 2 |
| TESAEs | 1 | 1 | 0 |
| TEAESIs | 0 | 1 | 0 |
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).
| Participants | DM: Placebo/DAX 300 mg OL | DM: DAX 300 mg/DAX 300 mg OL | ASIM: DAX 300 mg/DAX 300 mg OL |
|---|---|---|---|
| TEAEs | 2 | 1 | 2 |
| TESAEs | 0 | 0 | 0 |
| TEAESIs | 0 | 0 | 1 |
Collected over Stage I: Mortality from randomization, AEs from 1st dose of trial intervention in stage I, both to 1st dose of trial intervention in stage II or study end for non-stage II participants; both median (min, max) duration was 24 (3, 34) weeks. Stage II: Mortality/AE: 1st dose of trial intervention in stage II to study end; median (min, max) duration was 24 (18, 33) weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Stage I - DM: Placebo | 0/4 (0%) | 1/4 (25%) | 3/4 (75%) |
| Stage I - DM: DAX 300 mg | 0/5 (0%) | 1/5 (20%) | 4/5 (80%) |
| Stage I - ASIM: DAX 300 mg | 0/3 (0%) | 0/3 (0%) | 2/3 (66.7%) |
| Stage II - DM: Placebo/DAX 300 mg OL | 0/3 (0%) | 0/3 (0%) | 2/3 (66.7%) |
| Stage II - DM: DAX 300 mg/DAX 300 mg OL | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) |
| Stage II - ASIM: DAX 300 mg/DAX 300 mg OL | 0/2 (0%) | 0/2 (0%) | 2/2 (100%) |
| Event | Stage I - DM: Placebo | Stage I - DM: DAX 300 mg | Stage I - ASIM: DAX 300 mg | Stage II - DM: Placebo/DAX 300 mg OL | Stage II - DM: DAX 300 mg/DAX 300 mg OL | Stage II - ASIM: DAX 300 mg/DAX 300 mg OL |
|---|---|---|---|---|---|---|
| MyositisMusculoskeletal and connective tissue disorders | 1/4 | 0/5 | 0/3 | 0/3 | 0/3 | 0/2 |
| Rib fractureInjury, poisoning and procedural complications | 0/4 | 1/5 | 0/3 | 0/3 | 0/3 | 0/2 |
| Road traffic accidentInjury, poisoning and procedural complications | 0/4 | 1/5 | 0/3 | 0/3 | 0/3 | 0/2 |
| Sternal fractureInjury, poisoning and procedural complications | 0/4 | 1/5 | 0/3 | 0/3 | 0/3 | 0/2 |
| Subdural haematomaInjury, poisoning and procedural complications | 0/4 | 1/5 | 0/3 | 0/3 | 0/3 | 0/2 |
| Wrist fractureInjury, poisoning and procedural complications | 0/4 | 1/5 | 0/3 | 0/3 | 0/3 | 0/2 |
| Event | Stage I - DM: Placebo | Stage I - DM: DAX 300 mg | Stage I - ASIM: DAX 300 mg | Stage II - DM: Placebo/DAX 300 mg OL | Stage II - DM: DAX 300 mg/DAX 300 mg OL | Stage II - ASIM: DAX 300 mg/DAX 300 mg OL |
|---|---|---|---|---|---|---|
| Injection site erythemaGeneral disorders | 0/4 | 0/5 | 2/3 | 0/3 | 0/3 | 1/2 |
| DiarrhoeaGastrointestinal disorders | 2/4 | 0/5 | 0/3 | 0/3 | 0/3 | 0/2 |
| Oral herpesInfections and infestations | 0/4 | 0/5 | 0/3 | 0/3 | 0/3 | 1/2 |
| Upper respiratory tract infectionInfections and infestations | 0/4 | 1/5 | 0/3 | 0/3 | 0/3 | 1/2 |
| DermatomyositisMusculoskeletal and connective tissue disorders | 0/4 | 0/5 | 0/3 | 0/3 | 0/3 | 1/2 |
| Abdominal distensionGastrointestinal disorders | 0/4 | 0/5 | 1/3 | 0/3 | 0/3 | 0/2 |
| Abdominal painGastrointestinal disorders | 0/4 | 0/5 | 1/3 | 0/3 | 0/3 | 0/2 |
| NauseaGastrointestinal disorders | 0/4 | 0/5 | 1/3 | 1/3 | 0/3 | 0/2 |
| VomitingGastrointestinal disorders | 0/4 | 0/5 | 0/3 | 1/3 | 0/3 | 0/2 |
| Adverse drug reactionGeneral disorders | 0/4 | 0/5 | 0/3 | 0/3 | 1/3 | 0/2 |
Full Analysis Set (FAS): All randomized participants who received any dose of trial intervention in the trial.
| Age, Continuous(Years) | DM: Placebo/DAX 300 mg OL | DM: DAX 300 mg/DAX 300 mg OL | ASIM: DAX 300 mg/DAX 300 mg OL | Total |
|---|---|---|---|---|
| Mean | 44.3 ± 5.3 | 50.2 ± 11.6 | 45.3 ± 13.3 | 47.0 ± 9.9 |
| Sex: Female, Male(Participants) | DM: Placebo/DAX 300 mg OL | DM: DAX 300 mg/DAX 300 mg OL | ASIM: DAX 300 mg/DAX 300 mg OL | Total |
|---|---|---|---|---|
| Female | 3 | 4 | 3 | 10 |
| Male | 1 | 1 | 0 | 2 |
| Ethnicity (NIH/OMB)(Participants) | DM: Placebo/DAX 300 mg OL | DM: DAX 300 mg/DAX 300 mg OL | ASIM: DAX 300 mg/DAX 300 mg OL | Total |
|---|---|---|---|---|
| Hispanic or Latino | 1 | 4 | 1 | 6 |
| Not Hispanic or Latino | 3 | 1 | 2 | 6 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | DM: Placebo/DAX 300 mg OL | DM: DAX 300 mg/DAX 300 mg OL | ASIM: DAX 300 mg/DAX 300 mg OL | Total |
|---|---|---|---|---|
| White | 3 | 5 | 3 | 11 |
| Other | 1 | 0 | 0 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Data sharing details ↗ · www.amgen.com
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Daxdilimab