Trial · NCT03181893
A Study In Adults With Moderate To Severe Dermatomyositis
NCT03181893, Phase 2, Completed, Pfizer; results first posted 2023-09-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study In Adults With Moderate To Severe Dermatomyositis. Trials, record NCT03181893. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03181893
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study In Adults With Moderate To Severe Dermatomyositis
- NCT number
- NCT03181893
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 75 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Dermatomyositis
- Interventions
- PF-06823859 low, Placebo Arm, PF-06823859 high
- First posted
- 2017-06-09
- Last updated
- 2023-09-14
- Other registries' IDs
- eudract:2020-004228-41
- Results first posted
- 2023-09-14
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Activity Score at Week 12 (Stage 1, Stage 2 and Amended Stage 2) | Baseline and Week 12 | The treatment effect was defined as the difference (mean chg from baseline at Week12 in the active treatment group minus that in the placebo group) in the mean change of CDASI activity score from baseline at Week 12. The score (range: 0-100) consists of the extent score (ES), Gottorn hands score (GHS), peringual score (PS) and allopecia score (AS). ES (range: 0-90) was obtained by summing up scores for the total erythema (ER \[0-45\], redness of the skin or mucous membranes), scaling (SC \[0-30\], peeling of the skin) and erosion/ulceration (EU \[0-15\], presence of the deeper wound). Total ER, SC and EU scores were calculated as a sum of the contributions from 15 individual areas of the body. GHS characterizes papules (swellings) on hand and is a sum of the papule's characterization score (0-6) and ulceration score (0-1). PS (0-2) characterizes abnormalities around nails. The AS (0-1) characterizes hair loss. Higher scores indicate greater disease severity. |
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE) (Stage 3) | Up to Week 40 | Adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was any untoward medical occurrence that at any dose resulted in any of following outcomes/deemed significant for any other reason: death; initial /prolonged inpatient hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect and suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. AEs included both serious (if occurred) and all non-serious adverse events. TEAEs are events between first dose of study drug and up to Week 40 that were absent before treatment or that worsened relative to pretreatment state. |
| Primary | Number of Participants With Clinically Significant Laboratory Abnormalities (Stage 3) | Up to Week 40 | Hemoglobin(HGB),hematocrit,erythrocytes(ery.),HDL cholesterol(chl.)\<0.8\*lower limit of normal(LLN);reticulocytes (ret.), ret./ery.(%)\<0.5\*LLN,\>1.5\*upper limit of normal (ULN);ery. mean corpuscular(EMC) volume,EMC HGB concentration,potassium,chloride,calcium,bicarbonate\<0.9\*LLN,\>1.1\*ULN;platelets\<0.5\*LLN,\>1.75\*ULN; leukocytes(leu.),glucose\<0.6\*LLN,\>1.5\*ULN;lymphocytes(lym.), lym./leu.(%),neutrophils (neu.), neu./leu.(%), protein,albumin\<0.8\*LLN,\>1.2\*ULN;basophils(bas.), bas./leu.(%), eosinophils(eos.), eos./leu., monocytes(mon.), mon./leu.(%), urate\>1.2\*ULN;bilirubin (total, direct,indirect)\>1.5\*ULN;aspartate/alanine aminotransferase,gamma glutamyl transferase,lactate dehydrogenase,alkaline phosphatase\>3.0\*ULN;urea nitrogen,creatinine,triglycerides, chl.\>1.3\*ULN; sodium \<0.95\*LLN,\>1.05\*ULN; creatine kinase \>2.0\*ULN;Urine: pH\<4.5,\>8;glucose, ketones,protein, HGB,urobilinogen,bilirubin,nitrite,leukocyte esterase\>=1;ery., leu.\>= 20;hyaline casts\>1;bacteria\>20. |
| Primary | Number of Participants With Vital Sign Abnormalities (Stage 3) | Baseline up to Week 40 | Abnormality in vital signs: Sitting pulse rate \<40 beats per minute (bpm) to \>120 bpm, sitting diastolic blood pressure (DBP) \< 50 millimeter of mercury (mmHg), sitting systolic blood pressure (SBP) \<90 mmHg. |
| Primary | Number of Participants With Electrocardiogram (ECG) Abnormalities (Stage 3) | Baseline up to Week 40 | ECG abnormalities criteria included: 1) QTc interval adjusted according to Fridericia formula (QTcF) (msec): \>450, \>480, \>500, increase from baseline \>=30, increase from baseline \>=60; 2) Pulse rate (PR) (msec): \>=300, change from baseline (Chg) \>=25% or 50%; 3) QT (msec): \>=500; 4) QRS (msec): \>=200, Chg \>=25% or 50%. Categories, with at least 1 participant having ECG abnormality in any of the reporting arms, were reported in this outcome measure. |
| Secondary | Number of Participants With TEAEs and SAEs (Stage 1 and Stage 2) | Up to Week 28 | AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was any untoward medical occurrence that at any dose resulted in any of following outcomes/deemed significant for any other reason: death; initial /prolonged inpatient hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect and suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. AEs included both serious (if occurred) and all non-serious adverse events. TEAEs are events between first dose of study drug and up to Week 28 that were absent before treatment or that worsened relative to pretreatment state. |
| Secondary | Number of Participants With TEAEs and SAEs (Amended Stage 2) | Up to Week 40 | AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was any untoward medical occurrence that at any dose resulted in any of following outcomes/deemed significant for any other reason: death; initial /prolonged inpatient hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect and suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. AEs included both serious (if occurred) and all non-serious adverse events. TEAEs are events between first dose of study drug and up to Week 40 that were absent before treatment or that worsened relative to pretreatment state. |
| Secondary | Number of Participants With Clinically Significant Laboratory Abnormalities (Stage 1 and Stage 2) | Up to Week 28 | HGB,hematocrit,ery.,HDL chl.\<0.8\*LLN;ret., ret./ery. (%)\<0.5\*LLN,\>1.5\*ULN;EMC volume,EMC HGB,EMC HGB concentration,potassium,chloride,calcium,bicarbonate\<0.9\*LLN,\>1.1\*ULN;platelets\<0.5\*LLN,\>1.75\*ULN;leu.,glucose\<0.6\*LLN,\>1.5\*ULN;lym., lym./leu.(%), neu., neu./leu. (%), protein,albumin \<0.8\*LLN,\>1.2\*ULN;bas., bas./leu.(%), eos., eos./leu., mon., mon./leu.(%), urate \>1.2\*ULN;bilirubin (total, direct, indirect)\>1.5\*ULN;aspartate/alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase\>3.0\*ULN;urea nitrogen, creatinine, triglycerides, chl.\>1.3\*ULN; sodium \<0.95\*LLN,\>1.05\*ULN; creatine kinase \>2.0\*ULN;Urine: pH\<4.5,\>8;glucose, ketones, protein, HGB, urobilinogen,bilirubin,nitrite,leukocyte esterase\>=1;ery., leu.\>= 20;hyaline casts\>1;bacteria\>20. Clinical significance of laboratory parameters was determined at the investigator's discretion. |
| Secondary | Number of Participants With Clinically Significant Laboratory Abnormalities (Amended Stage 2) | Up to Week 40 | HGB,hematocrit,ery.,HDL chl.\<0.8\*LLN;ret., ret./ery. (%)\<0.5\*LLN,\>1.5\*ULN;EMC volume,EMC HGB,EMC HGB concentration,potassium,chloride,calcium,bicarbonate\<0.9\*LLN,\>1.1\*ULN;platelets\<0.5\*LLN,\>1.75\*ULN;leu.,glucose\<0.6\*LLN,\>1.5\*ULN;lym., lym./leu.(%), neu., neu./leu. (%), protein,albumin \<0.8\*LLN,\>1.2\*ULN;bas., bas./leu.(%), eos., eos./leu., mon., mon./leu.(%), urate \>1.2\*ULN;bilirubin (total, direct, indirect)\>1.5\*ULN;aspartate/alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase\>3.0\*ULN;urea nitrogen, creatinine, triglycerides, chl.\>1.3\*ULN; sodium \<0.95\*LLN,\>1.05\*ULN; creatine kinase \>2.0\*ULN;Urine: pH\<4.5,\>8;glucose, ketones, protein, HGB, urobilinogen,bilirubin,nitrite,leukocyte esterase\>=1;ery., leu.\>= 20;hyaline casts\>1;bacteria\>20. Clinical significance of laboratory parameters was determined at the investigator's discretion. |
| Secondary | Number of Participants With Vital Sign Abnormalities (Stage 1 and Stage 2) | Up to Week 28 | Abnormality in vital signs: Sitting pulse rate \<40 bpm to \>120 bpm, sitting DBP \< 50 mmHg, sitting SBP \<90 mmHg. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Activity Score at Week 12 (Stage 1, Stage 2 and Amended Stage 2) | Baseline and Week 12 | The Full Analysis Set (FAS) in Stage 1, Stage 2, and Amended Stage 2 included all participants who received at least 1 dose of randomized treatment in in Stage 1, Stage 2, or Amended Stage 2. | Units on a scale | MEAN |
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE) (Stage 3) | Up to Week 40 | The safety analysis set in Stage 3 (SAS3) included all participants who received at least 1 dose of randomized treatment in Stage 3. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Laboratory Abnormalities (Stage 3) | Up to Week 40 | The safety analysis set in Stage 3 (SAS3) included all participants who received at least 1 dose of randomized treatment in Stage 3. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Vital Sign Abnormalities (Stage 3) | Baseline up to Week 40 | The SAS3 included all participants who received at least 1 dose of randomized treatment in Stage 3. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Electrocardiogram (ECG) Abnormalities (Stage 3) | Baseline up to Week 40 | The SAS3 included all participants who received at least 1 dose of randomized treatment in Stage 3. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With TEAEs and SAEs (Stage 1 and Stage 2) | Up to Week 28 | The safety analysis set in Stage 1 (SAS1) and safety analysis set in Stage 2 (SAS2) included all participants who received at least 1 dose of randomized treatment in Stage 1 and Stage 2, respectively. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With TEAEs and SAEs (Amended Stage 2) | Up to Week 40 | The safety analysis set in Amended Stage 2 (SASA2) includes all participants who received at least one dose of randomized treatment in Amended Stage 2. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Laboratory Abnormalities (Stage 1 and Stage 2) | Up to Week 28 | The SAS1 and SAS2 included all participants who received at least 1 dose of randomized treatment in Stage 1 and Stage 2, respectively. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Laboratory Abnormalities (Amended Stage 2) | Up to Week 40 | The SASA2 includes all participants who received at least one dose of randomized treatment in Amended Stage 2. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Vital Sign Abnormalities (Stage 1 and Stage 2) | Up to Week 28 | The SAS1 and SAS2 included all participants who received at least 1 dose of randomized treatment in Stage 1 and Stage 2, respectively. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group389
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Activity Score at Week 12 (Stage 1, Stage 2 and Amended Stage 2) | (Stage 1) Placebo | -3.44 | Standard Deviation 5.270 | Units on a scale | |
| Change From Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Activity Score at Week 12 (Stage 1, Stage 2 and Amended Stage 2) | PF-06823859 600 mg IV (Stage 1) | -19.62 | Standard Deviation 9.140 | Units on a scale | |
| Change From Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Activity Score at Week 12 (Stage 1, Stage 2 and Amended Stage 2) | (Stage 2) Placebo | 5.00 | Units on a scale | ||
| Change From Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Activity Score at Week 12 (Stage 1, Stage 2 and Amended Stage 2) | (Stage 2) PF-06823859 150 mg IV | -17.40 | Standard Deviation 9.290 | Units on a scale | |
| Change From Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Activity Score at Week 12 (Stage 1, Stage 2 and Amended Stage 2) | (Stage 2) PF-06823859 600 mg IV | -26.00 | Standard Deviation 7.937 | Units on a scale | |
| Change From Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Activity Score at Week 12 (Stage 1, Stage 2 and Amended Stage 2) | (Amended Stage 2) Placebo Then Switched to PF-06823859 150 mg IV at Week 12 | -3.00 | Standard Deviation 8.485 | Units on a scale | |
| Change From Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Activity Score at Week 12 (Stage 1, Stage 2 and Amended Stage 2) | (Amended Stage 2) Placebo Then Switched to PF-06823859 600 mg IV at Week 12 | 3.00 | Units on a scale | ||
| Change From Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Activity Score at Week 12 (Stage 1, Stage 2 and Amended Stage 2) | (Amended Stage 2) PF-06823859 150 mg IV Then Switched to Placebo at Week 12 | -16.40 | Standard Deviation 5.835 | Units on a scale | |
| Change From Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Activity Score at Week 12 (Stage 1, Stage 2 and Amended Stage 2) | (Amended Stage 2) PF-06823859 600 mg IV Then Switched to Placebo at Week 12 | -15.33 | Standard Deviation 6.028 | Units on a scale | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE) (Stage 3) | (Stage 3) Placebo Then Switched to PF-06823859 600 mg IV at Week 12 | TEAEs | 7 | Participants |
1 to 10 of 389Source ClinicalTrials.gov
See all 389 results by groupParticipant flow66
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Baseline to Week 12 (All Stages) | STARTED | (Stage 1) Placebo | 10 | |
| Baseline to Week 12 (All Stages) | STARTED | (Stage 1) PF-06823859 600 mg Intravenous (IV) | 22 | |
| Baseline to Week 12 (All Stages) | STARTED | (Stage 2) Placebo | 1 | |
| Baseline to Week 12 (All Stages) | STARTED | (Stage 2) PF-06823859 150 mg IV | 5 | |
| Baseline to Week 12 (All Stages) | STARTED | (Stage 2) PF-06823859 600 mg IV | 3 | |
| Baseline to Week 12 (All Stages) | STARTED | (Amended Stage 2) Placebo Then Switched to PF-06823859 150 mg IV at Week 12 | 2 | |
| Baseline to Week 12 (All Stages) | STARTED | (Amended Stage 2) Placebo Then Switched to PF-06823859 600 mg IV at Week 12 | 1 | |
| Baseline to Week 12 (All Stages) | STARTED | (Amended Stage 2) PF-06823859 150 mg IV Then Switched to Placebo at Week 12 | 10 | |
| Baseline to Week 12 (All Stages) | STARTED | (Amended Stage 2) PF-06823859 600 mg IV Then Switched to Placebo at Week 12 | 3 | |
| Baseline to Week 12 (All Stages) | STARTED | (Stage 3) Placebo Then Switched to PF-06823859 600 mg IV at Week 12 | 9 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 participant flowAdverse events152
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Placebo | 0 | 45 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | PF-06823859 150 mg IV | 1 | 17 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | PF-06823859 600 mg IV | 0 | 47 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Total | 1 | 75 | |
| other | Tachycardia | Cardiac disorders | Placebo | 1 | 45 | |
| other | Tachycardia | Cardiac disorders | PF-06823859 150 mg IV | 1 | 17 | |
| other | Tachycardia | Cardiac disorders | PF-06823859 600 mg IV | 0 | 47 | |
| other | Tachycardia | Cardiac disorders | Total | 1 | 75 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 0 | 45 | |
| other | Abdominal pain | Gastrointestinal disorders | PF-06823859 150 mg IV | 1 | 17 |
1 to 10 of 152Source ClinicalTrials.gov
See all 152 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 1 | 45 |
| Total, all-cause mortality | PF-06823859 150 mg IV | 0 | 17 |
| Total, all-cause mortality | PF-06823859 600 mg IV | 1 | 47 |
| Total, all-cause mortality | Total | 1 | 75 |
| Total, other adverse events | Placebo | 22 | 45 |
| Total, other adverse events | PF-06823859 150 mg IV | 13 | 17 |
| Total, other adverse events | PF-06823859 600 mg IV | 18 | 47 |
| Total, other adverse events | Total | 45 | 75 |
| Total, serious adverse events | Placebo | 3 | 45 |
| Total, serious adverse events | PF-06823859 150 mg IV | 0 | 17 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
(Stage 3) Placebo Then Switched to PF-06823859 600 mg IV at Week 12 vs (Stage 3) PF-06823859 600 mg IV Then Switched to Placebo at Week 12: Number of Participants With Clinically Significant Laboratory Abnormalities (Stage 3) |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03181893
GET https://conductscience.org/api/trials/v1/NCT03181893/registered?page=2