Trial · NCT05192200
An Extension Study for Participants Who Have Completed the Treatment Period of a Qualifying Parent Study
NCT05192200, Phase 2, Completed, Pfizer; results first posted 2025-02-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Extension Study for Participants Who Have Completed the Treatment Period of a Qualifying Parent Study. Trials, record NCT05192200. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05192200
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Extension Study for Participants Who Have Completed the Treatment Period of a Qualifying Parent Study
- NCT number
- NCT05192200
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 24 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Dermatomyositis
- Interventions
- Anti-Beta Interferon (PF-06823859)
- First posted
- 2022-01-14
- Last updated
- 2025-02-06
- Other registries' IDs
- eudract:2021-004787-10
- Results first posted
- 2025-02-06
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From Day 1 of dosing maximum up to Week 68 | An Adverse Event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered treatment emergent relative to a given treatment if the event occurred for the first time during the effective duration of treatment and was not seen prior to the start of treatment, or the event was seen prior to the start of treatment but increased in severity during treatment. AEs included both serious adverse events (SAEs) and all non-SAEs. |
| Primary | Number of Participants With Laboratory Abnormalities | From Day 1 of dosing maximum up to Week 68 | Hematology laboratory parameters: hemoglobin (grams per deciliter \[g/dL\]); hematocrit (percentage \[%\]); lymphocytes (10\^3 per (/) millimeter\[mm\]\^3); lymphocytes/leukocytes (%); neutrophils (10\^3/mm\^3) less than (\<)0.8\*lower limit of normal (LLN), leukocytes (10\^3/mm\^3) \<0.6\*LLN, neutrophils (10\^3/mm\^3); basophils (10\^3/mm\^3); basophils/leukocytes (%); monocytes/leukocytes (%); activated partial thromboplastin time (seconds \[sec\]); prothrombin time (sec) more than (\>)1.2\*upper limit of normal (ULN). Clinical chemistry: potassium (milliequivalents per liter \[mEq/L\]); bicarbonate (mEq/L) \<0.9\*LLN, creatine kinase (units per liter \[U/L\]) \>2.0\*ULN, glucose (milligram per deciliter \[mg/dl\]); glucose-fasting (mg/dl) \>1.5\*ULN. Urinalysis: Urine glucose; ketones; urine protein; urine hemoglobin; nitrite; leukocyte esterase; hyaline casts (1/per leukocytosis promoting factor (more than or equal to \[\>=\] 1, urine erythrocytes (scalar); urine leukocytes (scalar) \>=20. |
| Primary | Number of Participants According to Categorization of Changes in Vital Signs | From Day 1 of dosing maximum up to Week 68 | Vital signs included the following parameters: sitting diastolic blood pressure (millimetres of mercury \[mmHg\]) change \>=20 mmHg increase; sitting systolic blood pressure (mmHg) change \>=30 mmHg increase, sitting diastolic blood pressure (mmHg) change \>=20 mmHg decrease and sitting systolic blood pressure (mmHg) change \>=30 mmHg decrease. |
| Primary | Number of Participants According to Categorization of Electrocardiogram (ECG) Findings | From Day 1 of dosing maximum up to Week 68 | ECG parameters evaluated were: PR interval value \>=300 milliseconds (msec); QRS duration value \>=200 msec; QT interval value \>=500 msec; corrected QT Interval using Fridericia's formula (QTCF) 450 less than or equal to (\<=) value \<480 msec, 480 \<=value\<500 msec and value\>=500 msec. |
| Secondary | Change From Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Activity Score at Week 52 | Baseline (before dose 1), Week 52 | CDASI is a validated DM-specific instrument designed to systematically quantify the extent of cutaneous disease. Disease involvement in 15 different anatomical locations was rated using three activity (erythema, scale, erosion/ulceration) and two damage (poikiloderma, calcinosis) measures. The presence and severity of Gottron's papules, periungual changes and alopecia were also captured. Total CDASI activity score was based on the physician's evaluation of three activities (erythema, scale, erosion/ulceration), presence and severity of Gottron's papules, periungual changes and alopecia. Total CDASI activity score ranged from 0 to 100, where higher scores indicated higher levels of disability. |
| Secondary | Change From Baseline in CDASI Activity Score at Weeks 12, 24, 36, and 48 | Baseline (before dose 1), Weeks 12, 24, 36 and 48 | CDASI is a validated DM-specific instrument designed to systematically quantify the extent of cutaneous disease. Disease involvement in 15 different anatomical locations was rated using three activity (erythema, scale, erosion/ulceration) and two damage (poikiloderma, calcinosis) measures. The presence and severity of Gottron's papules, periungual changes and alopecia were also captured. Total CDASI activity score was based on the physician's evaluation of three activities (erythema, scale, erosion/ulceration), presence and severity of Gottron's papules, periungual changes and alopecia. Total CDASI activity score ranged from 0 to 100, where higher scores indicated higher levels of disability. |
| Secondary | Absolute Values of CDASI Activity Score at Weeks 12, 24, 36, 48, and 52 | Weeks 12, 24, 36, 48 and 52 | CDASI is a validated DM-specific instrument designed to systematically quantify the extent of cutaneous disease. Disease involvement in 15 different anatomical locations was rated using three activity (erythema, scale, erosion/ulceration) and two damage (poikiloderma, calcinosis) measures. The presence and severity of Gottron's papules, periungual changes and alopecia were also captured. Total CDASI activity score was based on the physician's evaluation of three activities (erythema, scale, erosion/ulceration), presence and severity of Gottron's papules, periungual changes and alopecia. Total CDASI activity score ranged from 0 to 100, where higher scores indicated higher levels of disability. |
| Secondary | Change From Baseline in CDASI Damage Score at Weeks 12, 24, 36, 48, and 52 | Baseline (before dose on Day 1), Weeks 12, 24, 36, 48 and 52 | CDASI is a validated DM-specific instrument designed to systematically quantify the extent of cutaneous disease. Disease involvement in 15 different anatomical locations was rated using three activity (erythema, scale, erosion/ulceration) and two damage (poikiloderma, calcinosis) measures. The presence and severity of Gottron's papules, periungual changes and alopecia were also captured. Total CDASI damage score was based on the physician's evaluation of two damage (poikiloderma, calcinosis) measures, and presence and severity of Gottron's papules. Total CDASI damage score ranged from 0 to 32, where higher scores indicated higher level of skin damage. |
| Secondary | Absolute Values of CDASI Damage Score at Weeks 12, 24, 36, 48, and 52 | Weeks 12, 24, 36, 48 and 52 | CDASI is a validated DM-specific instrument designed to systematically quantify the extent of cutaneous disease. Disease involvement in 15 different anatomical locations was rated using three activity (erythema, scale, erosion/ulceration) and two damage (poikiloderma, calcinosis) measures. The presence and severity of Gottron's papules, periungual changes and alopecia were also captured. Total CDASI damage score was based on the physician's evaluation of two damage (poikiloderma, calcinosis) measures, and presence and severity of Gottron's papules. Total CDASI damage score ranged from 0 to 32, where higher scores indicated higher level of skin damage. |
| Secondary | Total Improvement Score (TIS) at Weeks 12, 24, 36, 48 and 52: Muscle Cohort | Weeks 12, 24, 36, 48 and 52 | There are 6 core set measure that comprised of TIS: 1) Physician Global Assessment Score \[PhGA\] (from Myositis Disease Activity Assessment Tool \[MDAAT\], 0-100 mm or 0-10 centimeter (cm) on visual analogue scale \[VAS\], higher scores= worse health status); 2) Patient Global Assessment Score \[PtGA\] (0-100 mm or 0-10 cm on VAS, higher scores= worse status); 3) Manual Muscle Testing-8 (MMT-8) designated muscle groups (0-80, lower scores= higher level of disability); 4) Health Assessment Questionnaire Disability Index \[HAQ-DI\] (0-3, higher scores= worse status); 5) Global Extramuscular Disease Activity (from MDAAT, 0-10 cm on a VAS, higher scores= higher level of disability); 6) Participant's most elevated muscle enzymes. TIS was sum of all 6 improvement scores associated with the change in each core set measure. TIS ranged from 0 to 100; where TIS\>=20 shows minimal improvement, TIS \>=40 shows moderate improvement and TIS \>= 60 shows major improvement. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From Day 1 of dosing maximum up to Week 68 | Safety Analysis Set included all participants enrolled who took at least 1 dose of study intervention, regardless of which stage the participant entered from. In this outcome measure data was planned to be reported for skin cohort/analysis set, muscle cohort/analysis set and all participants/safety analysis set. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Laboratory Abnormalities | From Day 1 of dosing maximum up to Week 68 | Safety Analysis Set included all participants enrolled who took at least 1 dose of study intervention, regardless of which stage the participant entered from. In this outcome measure data was planned to be reported for skin cohort/analysis set, muscle cohort/analysis set and all participants/safety analysis set. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants According to Categorization of Changes in Vital Signs | From Day 1 of dosing maximum up to Week 68 | Safety Analysis Set included all participants enrolled who took at least 1 dose of study intervention, regardless of which stage the participant entered from. In this outcome measure data was planned to be reported for skin cohort/analysis set, muscle cohort/analysis set and all participants/safety analysis set. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants According to Categorization of Electrocardiogram (ECG) Findings | From Day 1 of dosing maximum up to Week 68 | Safety Analysis Set included all participants enrolled who took at least 1 dose of study intervention, regardless of which stage the participant entered from. In this outcome measure data was planned to be reported for skin cohort/analysis set, muscle cohort/analysis set and all participants/safety analysis set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Activity Score at Week 52 | Baseline (before dose 1), Week 52 | Safety Analysis Set included all participants enrolled who took at least 1 dose of study intervention, regardless of which stage the participant entered from. In this outcome measure data was planned to be reported for skin cohort/analysis set and muscle cohort/analysis set. Here, Number of Participants Analyzed signifies number evaluable for this outcome measure. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in CDASI Activity Score at Weeks 12, 24, 36, and 48 | Baseline (before dose 1), Weeks 12, 24, 36 and 48 | Safety Analysis Set included all participants enrolled who took at least 1 dose of study intervention, regardless of which stage the participant entered from. In this outcome measure data was planned to be reported for skin cohort/analysis set and muscle cohort/analysis set. Here Number Analyzed signifies number of participants evaluable for specified rows. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Values of CDASI Activity Score at Weeks 12, 24, 36, 48, and 52 | Weeks 12, 24, 36, 48 and 52 | Safety Analysis Set included all participants enrolled who took at least 1 dose of study intervention, regardless of which stage the participant entered from. In this outcome measure data was planned to be reported for skin cohort/analysis set and muscle cohort/analysis set. Here, Number Analyzed signifies number evaluable for specified rows. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in CDASI Damage Score at Weeks 12, 24, 36, 48, and 52 | Baseline (before dose on Day 1), Weeks 12, 24, 36, 48 and 52 | Safety Analysis Set included all participants enrolled who took at least 1 dose of study intervention, regardless of which stage the participant entered from. In this outcome measure data was planned to be reported for skin cohort/analysis set and muscle cohort/analysis set. Here Number Analyzed signifies number evaluable for specified rows. | Units on a scale | MEAN |
| SECONDARY | Absolute Values of CDASI Damage Score at Weeks 12, 24, 36, 48, and 52 | Weeks 12, 24, 36, 48 and 52 | Safety Analysis Set included all participants enrolled who took at least 1 dose of study intervention, regardless of which stage the participant entered from. In this outcome measure data was planned to be reported for skin cohort/analysis set and muscle cohort/analysis set. Here Number Analyzed signifies number evaluable for specified rows. | Units on a scale | MEAN |
| SECONDARY | Total Improvement Score (TIS) at Weeks 12, 24, 36, 48 and 52: Muscle Cohort | Weeks 12, 24, 36, 48 and 52 | Safety Analysis Set included all participants enrolled who took at least 1 dose of study intervention, regardless of which stage the participant entered from. In this outcome measure data was planned to be reported for muscle cohort/analysis set. Here Number Analyzed signifies number evaluable for specified rows. | Units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group111
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | PF-06823859 600mg: Skin Cohort | 7 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | PF-06823859 600mg: Muscle Cohort | 13 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | PF-06823859 600mg: All Participants | 20 | Participants | ||
| Number of Participants With Laboratory Abnormalities | PF-06823859 600mg: Skin Cohort | 8 | Participants | ||
| Number of Participants With Laboratory Abnormalities | PF-06823859 600mg: Muscle Cohort | 14 | Participants | ||
| Number of Participants With Laboratory Abnormalities | PF-06823859 600mg: All Participants | 22 | Participants | ||
| Number of Participants According to Categorization of Changes in Vital Signs | PF-06823859 600mg: Skin Cohort | Increase: sitting diastolic blood pressure (mmHg) | 4 | Participants | |
| Number of Participants According to Categorization of Changes in Vital Signs | PF-06823859 600mg: Muscle Cohort | Increase: sitting diastolic blood pressure (mmHg) | 4 | Participants | |
| Number of Participants According to Categorization of Changes in Vital Signs | PF-06823859 600mg: All Participants | Increase: sitting diastolic blood pressure (mmHg) | 8 | Participants | |
| Number of Participants According to Categorization of Changes in Vital Signs | PF-06823859 600mg: Skin Cohort | Increase: sitting systolic blood pressure (mmHg) | 4 | Participants |
1 to 10 of 111Source ClinicalTrials.gov
See all 111 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period | STARTED | PF-06823859 600mg: All Participants | 24 | |
| Treatment Period | Safety Analysis Set | PF-06823859 600mg: All Participants | 24 | |
| Treatment Period | Skin Analysis Set | PF-06823859 600mg: All Participants | 9 | |
| Treatment Period | Muscle Analysis Set | PF-06823859 600mg: All Participants | 15 | |
| Treatment Period | COMPLETED | PF-06823859 600mg: All Participants | 21 | |
| Treatment Period | NOT COMPLETED | PF-06823859 600mg: All Participants | 3 | |
| Follow-up | STARTED | PF-06823859 600mg: All Participants | 22 | |
| Follow-up | COMPLETED | PF-06823859 600mg: All Participants | 21 | |
| Follow-up | NOT COMPLETED | PF-06823859 600mg: All Participants | 1 |
Source ClinicalTrials.gov
Adverse events210
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 | Anaemia | Blood and lymphatic system disorders | PF-06823859 600mg: Skin Cohort | 1 | 9 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-06823859 600mg: Muscle Cohort | 1 | 15 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-06823859 600mg: All Participants | 2 | 24 | |
| other | Palpitations | Cardiac disorders | PF-06823859 600mg: Skin Cohort | 1 | 9 | |
| other | Palpitations | Cardiac disorders | PF-06823859 600mg: Muscle Cohort | 0 | 15 | |
| other | Palpitations | Cardiac disorders | PF-06823859 600mg: All Participants | 1 | 24 | |
| other | Abdominal pain | Gastrointestinal disorders | PF-06823859 600mg: Skin Cohort | 0 | 9 | |
| other | Abdominal pain | Gastrointestinal disorders | PF-06823859 600mg: Muscle Cohort | 2 | 15 | |
| other | Abdominal pain | Gastrointestinal disorders | PF-06823859 600mg: All Participants | 2 | 24 | |
| other | Diarrhoea | Gastrointestinal disorders | PF-06823859 600mg: Skin Cohort | 1 | 9 |
1 to 10 of 210Source ClinicalTrials.gov
See all 210 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PF-06823859 600mg: Skin Cohort | 0 | 9 |
| Total, all-cause mortality | PF-06823859 600mg: Muscle Cohort | 0 | 15 |
| Total, all-cause mortality | PF-06823859 600mg: All Participants | 0 | 24 |
| Total, other adverse events | PF-06823859 600mg: Skin Cohort | 7 | 9 |
| Total, other adverse events | PF-06823859 600mg: Muscle Cohort | 13 | 15 |
| Total, other adverse events | PF-06823859 600mg: All Participants | 20 | 24 |
| Total, serious adverse events | PF-06823859 600mg: Skin Cohort | 1 | 9 |
| Total, serious adverse events | PF-06823859 600mg: Muscle Cohort | 2 | 15 |
| Total, serious adverse events | PF-06823859 600mg: All Participants | 3 | 24 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42542380 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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