A Study In Adults With Moderate To Severe Dermatomyositis

A PHASE 2 DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF PF-06823859 IN ADULT SUBJECTS WITH DERMATOMYOSITIS

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03181893

Enrollment

Registered

2017-06-09

Start date

2018-01-23

Completion date

2022-11-28

Last updated

2023-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dermatomyositis

Brief summary

A Study looking at Investigational drug and Placebo administered to adult Patients with moderate to severe Dermatomyositis

Interventions

DRUGPF-06823859 low

A humanized immunoglobulin neutralizing antibody

DRUGPlacebo Arm

Placebo contains histidine, sucrose, PS80, ethylene diamine, and triacetic acid

DRUGPF-06823859 high

A humanized immunoglobulin neutralizing antibody

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

for Patients with Skin Predominant Activity: * Must have CDASI Activity score of greater than or equal to 14, and have failed at least 1 standard of care systemic treatment, (eg, corticosteroids). * Confirmation of DM by the investigator and two of the following: 1. Gottron's papules; 2. Gottron's sign; 3. Heliotrope eruption; 4. Nailfold changes, (dilated capillary loops, capillary dropout, cuticular hypertrophy and/or rugged cuticles; 5. Photodistributed violaceous erythema, (skin that is exposed to sunlight and appears purplish/reddish, and patchy in appearance; 6. Positive DM serology - * Post DM diagnosis; standard of care workup for DM must have been completed prior to entry into this research study. * Willing to provide 8 biopsies during the course of the research study Inclusion Criteria for Patients with Muscle Predominant Activity: * MMT-8 ≤136/150 and PhGA, VAS ≥3 cm (0-10 cm) by visual analog scale (VAS) * Sum of PhGA, VAS, PtGA, and extramuscular global assessment VAS scores is ≥10 cm (0-10 cm) VAS for each. * Participant has failed at least two or more adequate courses of an immunosuppressive agent or immunomodulatory agent, including IVIG, at a dose known to be effective for rheumatologic diseases.

Exclusion criteria

for Patients with Skin Predominant Activity: * Investigator site staff or members of their family. * Acute and Chronic present medical conditions * Intake of greater than 15 mg of prednisone or equivalent per day * Pregnant or breastfeeding females. Fertile men and women who will not comply with the use of 2 effective birth control methods as per the research protocol * Have required management of acute or chronic infections * Have pre existing demyelinating disorder such as multiple sclerosis, or other severe neurological deficits. * Clinically significant lab abnormalities * Any health condition that may be worsened by immunosuppression

Design outcomes

Primary

Measure	Time frame	Description
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.
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.
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.
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.
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

Measure	Time frame	Description
Number of Participants With Vital Sign Abnormalities (Amended Stage 2)	Up to Week 40	Abnormality in vital signs: Sitting pulse rate \<40 bpm to \>120 bpm, sitting DBP \< 50 mmHg, sitting SBP \<90 mmHg.
Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	Up to Week 28	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.
Number of Participants With ECG Abnormalities (Amended Stage 2)	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.
Change From Baseline in CDASI Activity Score at at All Scheduled Timepoints Through Week 12 (Stage 1, Stage 2 and Amended Stage 2)	Baseline, Week 1, Week 4, and Week 8 (except for Week 12 which is a primary outcome measure)	The treatment effect was defined as the difference (mean change from baseline at Weeks 1, 4, 8 in the active treatment group minus the mean change from baseline at Weeks 1, 4, 8 in the placebo group) in the mean change of CDASI activity score from baseline at scheduled timepoints. The score (range: 0-100) consists of the ES, GHS, PS and 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.
Change From Baseline in CDASI Activity Score at All Scheduled Timepoints Through Week 12 (Stage 3)	Baseline, Week 1, Week 4, Week 8 and Week 12	The treatment effect was defined as the difference (mean change from baseline at Weeks 1, 4, 8,12 in the active treatment group minus the mean change from baseline at Weeks 1, 4, 8, 12 in the placebo group) in the mean change of CDASI activity score from baseline at scheduled timepoints. The score (range: 0-100) consists of the ES, GHS, PS and 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.
Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Baseline, Week 1, Week 4, Week 8 and Week 12	The CDASI activity score (range: 0-100) consists of the ES, GHS, PS and 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.
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.
Absolute Values for Total Improvement Score (TIS) at Week 12 and Intermediate Scheduled Time Points (Stage 3)	Week 4, Week 8 and Week 12	The TIS was the sum of all 6 improvement scores where higher score indicates worse status (PhGA \[from the MDAAT, 0-20 scale\], PtGA \[0-10 scale\], MMT \[0-35 scale\], HAQ-DI \[0-10 scale\], muscle enzymes \[0-7.5 scale\], and extramuscular global assessment \[0-20 scale\]) associated with the change in each core set measure. A total improvement score between 0 and 100 corresponded to the degree of improvement, with higher scores corresponding to a greater degree of improvement: of ≥20 represented minimal improvement, a score of ≥40 represented moderate improvement, and a score of ≥60 represented major improvement.
Change From Baseline in the Core Set Measures (CSM) of the TIS (Global Disease Activity [PhGA] and Extramuscular Global Assessment [EmGA]) (Stage 3)	Baseline, Week 4, Week 8 and Week 12	PhGA: assessment of the severity of disease by the physician. The physician used the visual analog scale and put a mark on 0 cm (best) -10 cm (worst) scale where higher score indicated worse status. EmGA: overall evaluation of disease activity in all extramuscular systems using visual analog scale 0 cm (best) -10 cm (worst) scale where higher score indicated worse status.
Change From Baseline in the CSM of the TIS (PtGA) (Stage 3)	Baseline, Week 4, Week 8 and Week 12	PtGA: assessment of the severity of disease by the participant/participant's guardian, using a visual analog scale from 0 mm (no evidence of disease activity) to 100 mm (extremely active or severe disease activity). Higher score indicated worse status.
Change From Baseline in the CSM of the TIS (MMT8 and HAQ01-HAQ-DI) (Stage 3)	Week 4, Week 8 and Week 12	Manual Muscle Testing-8 designated muscle groups (MMT-8): was a set of 8 designated muscles tested unilaterally generally on right side (left side used unless right side cannot be used). Potential score range was from 0 to 80, where higher scores denoted better health status. HAQ-DI: contained eight sections (including dressing & grooming, arising, eating, walking, hygiene, grip, reach, and activities). Each section had multiple questions that the participant used to rank their functionality and ranged from 0 to 3 where 0 = without any difficulty and 3 = unable to do. For each participant, the average ranking was calculated for each of the eight sections. HAQ-DI had a score range of 0 to 3, where higher score reflected worse status.
Change From Baseline in the CSM of the TIS (Aldolase and Creatine Kinase) (Stage 3)	Baseline, Week 4, Week 8 and Week 12	The LS mean (with 90% CI) of CSM of the TIS (aldolase and creatine kinase) at weeks 4, 8, 12 were presented.
Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Baseline, Week 1, Week 4, Week 8 and Week 12	The Damage Score (DS) was calculated as a sum of the total poilkiloderma score (POLS), total calcinosis score (CALS) and Gotorn's hands damage score (GHDS). The POLS characterizes specific dispigmentation in the particulal area and calcinosis score characterizes calcification of the skin in the particular area. The POLS and the CALS are summed up over 15 individual areas in the body and each of them has range 0-15. The GHDS has the range 0-2 so that the DS has the range 0-32. Higher scores indicate greater disease severity.
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.
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.
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.
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.

Countries

Germany, Hungary, Poland, Spain, United States

Participant flow

Pre-assignment details

A total of 75 participants were randomized at 19 centers in 5 countries: 32, 9, 16 and 18 participants were treated in Stage 1, Stage 2, Amended Stage 2 and Stage 3, respectively. A fixed sequence design with crossover at Week 12 was employed in Amended Stage 2 and Stage 3 to provide all participants with the opportunity to receive active drug during the treatment period.

Participants by arm

Arm	Count
(Stage 1) Placebo Participants in this group were randomized to receive placebo on Day 1, Week 4, and Week 8. After week 12, participants went into a follow up period.	10
(Stage 1) PF-06823859 600 mg Intravenous (IV) Participants in this group were randomized to receive PF-06823859 600 mg on Day 1, Week 4, and Week 8. After week 12, participants went into a follow up period.	22
(Stage 2) Placebo Participants in this group were randomized to receive placebo on Day 1, Week 4, and Week 8. After week 12, participants went into a follow up period.	1
(Stage 2) PF-06823859 150 mg IV Participants in this group were randomized to receive PF-06823859 150 mg on Day 1, Week 4, and Week 8 After week 12, participants went into a follow up period.	5
(Stage 2) PF-06823859 600 mg IV Dosing occurred Day 1, Week 4, and Week 8. After week 12, participants went into a follow-up period.	3
(Amended Stage 2) Placebo Then Switched to PF-06823859 150 mg IV at Week 12 Dosing occurred Day 1, Weeks 4, 8, 12, 16, 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.	2
(Amended Stage 2) Placebo Then Switched to PF-06823859 600 mg IV at Week 12 Dosing occurred on Day 1, Weeks 4, 8, 12, 16, 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.	1
(Amended Stage 2) PF-06823859 150 mg IV Then Switched to Placebo at Week 12 Dosing occurred Day 1, Weeks 4, 8, 12, 16 and 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.	10
(Amended Stage 2) PF-06823859 600 mg IV Then Switched to Placebo at Week 12 Dosing occurred Day 1, Weeks 4, 8, 12, 16, and 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.	3
(Stage 3) Placebo Then Switched to PF-06823859 600 mg IV at Week 12 Dosing occurred Day 1, Weeks 4, 8, 12, 16, 20. At Week 24, participants entered a 4-month follow-up period or rolled over to the long-term extension study.	9
(Stage 3) PF-06823859 600 mg IV Then Switched to Placebo at Week 12 Dosing occurred Day 1, Weeks 4, 8, 12, 16, and 20. At Week 24, participants entered a 4-month follow-up period or rolled over to the long-term extension study.	9
Total	75

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG007	FG008	FG009	FG010
Baseline to Week 12 (All Stages)	Adverse Event	1	1	0	0	0	0
Baseline to Week 12 (All Stages)	Withdrawal by Subject	0	1	0	0	0	0
Weeks 12-24 (Amended Stage 2, Stage 3)	Adverse Event	0	0	0	0	0	1
Weeks 12-24 (Amended Stage 2, Stage 3)	Other	0	0	1	1	0	0
Weeks 12-24 (Amended Stage 2, Stage 3)	Withdrawal by Subject	0	0	0	0	1	0

Baseline characteristics

Characteristic	(Stage 1) PF-06823859 600 mg Intravenous (IV)	(Stage 2) Placebo	(Stage 2) PF-06823859 150 mg IV	(Stage 2) PF-06823859 600 mg IV	(Amended Stage 2) Placebo Then Switched to PF-06823859 150 mg IV at Week 12	(Amended Stage 2) Placebo Then Switched to PF-06823859 600 mg IV at Week 12	(Amended Stage 2) PF-06823859 150 mg IV Then Switched to Placebo at Week 12	(Amended Stage 2) PF-06823859 600 mg IV Then Switched to Placebo at Week 12	(Stage 3) Placebo Then Switched to PF-06823859 600 mg IV at Week 12	(Stage 1) Placebo	(Stage 3) PF-06823859 600 mg IV Then Switched to Placebo at Week 12	Total
Age, Continuous	54.41 years STANDARD_DEVIATION 13.154	42.00 years	51.60 years STANDARD_DEVIATION 15.726	45.67 years STANDARD_DEVIATION 23.714	64.00 years STANDARD_DEVIATION 1.414	44 years	53.90 years STANDARD_DEVIATION 10.999	47.00 years STANDARD_DEVIATION 13.115	47.44 years STANDARD_DEVIATION 12.126	50.20 years STANDARD_DEVIATION 14.054	42.44 years STANDARD_DEVIATION 16.697	50.63 years STANDARD_DEVIATION 13.793
Age, Customized 18-64 Years	18 Participants	1 Participants	4 Participants	2 Participants	1 Participants	1 Participants	8 Participants	3 Participants	8 Participants	8 Participants	8 Participants	62 Participants
Age, Customized 65-84 Years	4 Participants	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	2 Participants	0 Participants	1 Participants	2 Participants	1 Participants	13 Participants
Age, Customized >=85 Years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	3 Participants	2 Participants	2 Participants	13 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants	0 Participants	5 Participants	2 Participants	2 Participants	1 Participants	9 Participants	2 Participants	6 Participants	8 Participants	7 Participants	62 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Asian	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants
Race/Ethnicity, Customized Black or African American	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Multiracial	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Not reported	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	3 Participants
Race/Ethnicity, Customized Other	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized White	20 Participants	1 Participants	5 Participants	3 Participants	2 Participants	1 Participants	9 Participants	3 Participants	8 Participants	9 Participants	8 Participants	69 Participants
Sex: Female, Male Female	20 Participants	1 Participants	5 Participants	3 Participants	2 Participants	1 Participants	10 Participants	2 Participants	6 Participants	9 Participants	7 Participants	66 Participants
Sex: Female, Male Male	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	3 Participants	1 Participants	2 Participants	9 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	1 / 45	0 / 17	1 / 47	1 / 75
other Total, other adverse events	22 / 45	13 / 17	18 / 47	45 / 75
serious Total, serious adverse events	3 / 45	0 / 17	4 / 47	5 / 75

Outcome results

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)

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.

Time frame: Baseline and Week 12

Population: 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.

Arm	Measure	Value (MEAN)	Dispersion
(Stage 1) Placebo	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)	-3.44 Units on a scale	Standard Deviation 5.27
PF-06823859 600 mg IV (Stage 1)	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)	-19.62 Units on a scale	Standard Deviation 9.14
(Stage 2) Placebo	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)	5.00 Units on a scale	—
(Stage 2) PF-06823859 150 mg IV	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)	-17.40 Units on a scale	Standard Deviation 9.29
(Stage 2) PF-06823859 600 mg IV	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)	-26.00 Units on a scale	Standard Deviation 7.937
(Amended Stage 2) Placebo Then Switched to PF-06823859 150 mg IV at Week 12	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)	-3.00 Units on a scale	Standard Deviation 8.485
(Amended Stage 2) Placebo Then Switched to PF-06823859 600 mg IV at Week 12	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)	3.00 Units on a scale	—
(Amended Stage 2) PF-06823859 150 mg IV Then Switched to Placebo at Week 12	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)	-16.40 Units on a scale	Standard Deviation 5.835
(Amended Stage 2) PF-06823859 600 mg IV Then Switched to Placebo at Week 12	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)	-15.33 Units on a scale	Standard Deviation 6.028

p-value: <0.000190% CI: [-20.26, -9.37]LANCOVA-P model

Primary

Number of Participants With Clinically Significant Laboratory Abnormalities (Stage 3)

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.

Time frame: Up to Week 40

Population: The safety analysis set in Stage 3 (SAS3) included all participants who received at least 1 dose of randomized treatment in Stage 3.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
(Stage 1) Placebo	Number of Participants With Clinically Significant Laboratory Abnormalities (Stage 3)	0 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With Clinically Significant Laboratory Abnormalities (Stage 3)	1 Participants

Primary

Number of Participants With Electrocardiogram (ECG) Abnormalities (Stage 3)

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.

Time frame: Baseline up to Week 40

Population: The SAS3 included all participants who received at least 1 dose of randomized treatment in Stage 3.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
(Stage 1) Placebo	Number of Participants With Electrocardiogram (ECG) Abnormalities (Stage 3)	PR Interval Aggregate Value >=300 msec	0 Participants
(Stage 1) Placebo	Number of Participants With Electrocardiogram (ECG) Abnormalities (Stage 3)	QRS Duration Aggregate Value >=200 msec	0 Participants
(Stage 1) Placebo	Number of Participants With Electrocardiogram (ECG) Abnormalities (Stage 3)	QT Interval Aggregate Value >=500 msec	0 Participants
(Stage 1) Placebo	Number of Participants With Electrocardiogram (ECG) Abnormalities (Stage 3)	QTcF Interval Aggregate 450<=Value<480 msec	0 Participants
(Stage 1) Placebo	Number of Participants With Electrocardiogram (ECG) Abnormalities (Stage 3)	QTcF Interval Aggregate 480<=Value<500 msec	1 Participants
(Stage 1) Placebo	Number of Participants With Electrocardiogram (ECG) Abnormalities (Stage 3)	QTcF Interval Aggregate Value >=500 msec	0 Participants
(Stage 1) Placebo	Number of Participants With Electrocardiogram (ECG) Abnormalities (Stage 3)	PR %Chg >=25% or >=50%	0 Participants
(Stage 1) Placebo	Number of Participants With Electrocardiogram (ECG) Abnormalities (Stage 3)	QRS Duration %Chg >=25% or >=50%	0 Participants
(Stage 1) Placebo	Number of Participants With Electrocardiogram (ECG) Abnormalities (Stage 3)	30<=QTcF Chg (msec)<60	0 Participants
(Stage 1) Placebo	Number of Participants With Electrocardiogram (ECG) Abnormalities (Stage 3)	QTcF Chg (msec) >=60	0 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With Electrocardiogram (ECG) Abnormalities (Stage 3)	QRS Duration %Chg >=25% or >=50%	0 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With Electrocardiogram (ECG) Abnormalities (Stage 3)	PR Interval Aggregate Value >=300 msec	0 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With Electrocardiogram (ECG) Abnormalities (Stage 3)	QTcF Interval Aggregate Value >=500 msec	0 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With Electrocardiogram (ECG) Abnormalities (Stage 3)	QRS Duration Aggregate Value >=200 msec	0 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With Electrocardiogram (ECG) Abnormalities (Stage 3)	QTcF Chg (msec) >=60	1 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With Electrocardiogram (ECG) Abnormalities (Stage 3)	QT Interval Aggregate Value >=500 msec	0 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With Electrocardiogram (ECG) Abnormalities (Stage 3)	PR %Chg >=25% or >=50%	0 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With Electrocardiogram (ECG) Abnormalities (Stage 3)	QTcF Interval Aggregate 450<=Value<480 msec	1 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With Electrocardiogram (ECG) Abnormalities (Stage 3)	30<=QTcF Chg (msec)<60	0 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With Electrocardiogram (ECG) Abnormalities (Stage 3)	QTcF Interval Aggregate 480<=Value<500 msec	0 Participants

Primary

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE) (Stage 3)

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.

Time frame: Up to Week 40

Population: The safety analysis set in Stage 3 (SAS3) included all participants who received at least 1 dose of randomized treatment in Stage 3.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
(Stage 1) Placebo	Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE) (Stage 3)	TEAEs	7 Participants
(Stage 1) Placebo	Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE) (Stage 3)	SAEs	0 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE) (Stage 3)	TEAEs	8 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE) (Stage 3)	SAEs	2 Participants

Primary

Number of Participants With Vital Sign Abnormalities (Stage 3)

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.

Time frame: Baseline up to Week 40

Population: The SAS3 included all participants who received at least 1 dose of randomized treatment in Stage 3.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
(Stage 1) Placebo	Number of Participants With Vital Sign Abnormalities (Stage 3)	Sitting SBP Value <90 mmHg	0 Participants
(Stage 1) Placebo	Number of Participants With Vital Sign Abnormalities (Stage 3)	Sitting DBP Value <50 mmHg	0 Participants
(Stage 1) Placebo	Number of Participants With Vital Sign Abnormalities (Stage 3)	Sitting Pulse Rate Value <40 bpm	0 Participants
(Stage 1) Placebo	Number of Participants With Vital Sign Abnormalities (Stage 3)	Sitting Pulse Rate Value >120 bpm	0 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With Vital Sign Abnormalities (Stage 3)	Sitting Pulse Rate Value >120 bpm	0 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With Vital Sign Abnormalities (Stage 3)	Sitting SBP Value <90 mmHg	0 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With Vital Sign Abnormalities (Stage 3)	Sitting Pulse Rate Value <40 bpm	0 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With Vital Sign Abnormalities (Stage 3)	Sitting DBP Value <50 mmHg	0 Participants

Secondary

Absolute Values for Total Improvement Score (TIS) at Week 12 and Intermediate Scheduled Time Points (Stage 3)

The TIS was the sum of all 6 improvement scores where higher score indicates worse status (PhGA \[from the MDAAT, 0-20 scale\], PtGA \[0-10 scale\], MMT \[0-35 scale\], HAQ-DI \[0-10 scale\], muscle enzymes \[0-7.5 scale\], and extramuscular global assessment \[0-20 scale\]) associated with the change in each core set measure. A total improvement score between 0 and 100 corresponded to the degree of improvement, with higher scores corresponding to a greater degree of improvement: of ≥20 represented minimal improvement, a score of ≥40 represented moderate improvement, and a score of ≥60 represented major improvement.

Time frame: Week 4, Week 8 and Week 12

Population: The FAS3 included all participants who received at least 1 dose of randomized treatment in Stage 3.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)
(Stage 1) Placebo	Absolute Values for Total Improvement Score (TIS) at Week 12 and Intermediate Scheduled Time Points (Stage 3)	Week 4	25.83 Units on a scale
(Stage 1) Placebo	Absolute Values for Total Improvement Score (TIS) at Week 12 and Intermediate Scheduled Time Points (Stage 3)	Week 8	36.67 Units on a scale
(Stage 1) Placebo	Absolute Values for Total Improvement Score (TIS) at Week 12 and Intermediate Scheduled Time Points (Stage 3)	Week 12	36.94 Units on a scale
PF-06823859 600 mg IV (Stage 1)	Absolute Values for Total Improvement Score (TIS) at Week 12 and Intermediate Scheduled Time Points (Stage 3)	Week 4	36.67 Units on a scale
PF-06823859 600 mg IV (Stage 1)	Absolute Values for Total Improvement Score (TIS) at Week 12 and Intermediate Scheduled Time Points (Stage 3)	Week 8	49.17 Units on a scale
PF-06823859 600 mg IV (Stage 1)	Absolute Values for Total Improvement Score (TIS) at Week 12 and Intermediate Scheduled Time Points (Stage 3)	Week 12	56.39 Units on a scale

Comparison: Difference of the active treatment from Placebo at Week 4p-value: 0.153790% CI: [-7.1, 28.77]Mixed Models Analysis

Comparison: Difference of the active treatment from Placebo at Week 8p-value: 0.131290% CI: [-6.29, 31.29]Mixed Models Analysis

Comparison: Difference of the active treatment from Placebo at Week 12p-value: 0.064790% CI: [-1.79, 40.68]Mixed Models Analysis

Secondary

Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)

The CDASI activity score (range: 0-100) consists of the ES, GHS, PS and 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.

Time frame: Baseline, Week 1, Week 4, Week 8 and Week 12

Population: The FAS included all participants who received at least 1 dose of randomized treatment in any study stage.

Arm	Measure	Group	Value (MEAN)	Dispersion
(Stage 1) Placebo	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 12	27.11 Units on a scale	Standard Deviation 14.903
(Stage 1) Placebo	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 1	28.90 Units on a scale	Standard Deviation 12.982
(Stage 1) Placebo	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Baseline	31.50 Units on a scale	Standard Deviation 11.75
(Stage 1) Placebo	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 4	28.11 Units on a scale	Standard Deviation 16.136
(Stage 1) Placebo	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 8	26.33 Units on a scale	Standard Deviation 13.892
PF-06823859 600 mg IV (Stage 1)	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Baseline	33.23 Units on a scale	Standard Deviation 10.323
PF-06823859 600 mg IV (Stage 1)	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 8	15.29 Units on a scale	Standard Deviation 6.157
PF-06823859 600 mg IV (Stage 1)	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 1	27.68 Units on a scale	Standard Deviation 8.962
PF-06823859 600 mg IV (Stage 1)	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 4	21.23 Units on a scale	Standard Deviation 11.182
PF-06823859 600 mg IV (Stage 1)	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 12	12.86 Units on a scale	Standard Deviation 5.876
(Stage 2) Placebo	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 4	26.00 Units on a scale	—
(Stage 2) Placebo	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 12	28.00 Units on a scale	—
(Stage 2) Placebo	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 1	24.00 Units on a scale	—
(Stage 2) Placebo	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Baseline	23.00 Units on a scale	—
(Stage 2) Placebo	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 8	27.00 Units on a scale	—
(Stage 2) PF-06823859 150 mg IV	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 8	14.40 Units on a scale	Standard Deviation 5.857
(Stage 2) PF-06823859 150 mg IV	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 4	17.40 Units on a scale	Standard Deviation 2.408
(Stage 2) PF-06823859 150 mg IV	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 12	11.20 Units on a scale	Standard Deviation 4.817
(Stage 2) PF-06823859 150 mg IV	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Baseline	28.60 Units on a scale	Standard Deviation 9.017
(Stage 2) PF-06823859 150 mg IV	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 1	18.80 Units on a scale	Standard Deviation 6.535
(Stage 2) PF-06823859 600 mg IV	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 12	11.00 Units on a scale	Standard Deviation 3.464
(Stage 2) PF-06823859 600 mg IV	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 4	22.00 Units on a scale	Standard Deviation 12.49
(Stage 2) PF-06823859 600 mg IV	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 8	18.33 Units on a scale	Standard Deviation 5.508
(Stage 2) PF-06823859 600 mg IV	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 1	34.67 Units on a scale	Standard Deviation 9.713
(Stage 2) PF-06823859 600 mg IV	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Baseline	37.00 Units on a scale	Standard Deviation 9.644
(Amended Stage 2) Placebo Then Switched to PF-06823859 150 mg IV at Week 12	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 4	23.00 Units on a scale	Standard Deviation 1.414
(Amended Stage 2) Placebo Then Switched to PF-06823859 150 mg IV at Week 12	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Baseline	26.00 Units on a scale	Standard Deviation 5.657
(Amended Stage 2) Placebo Then Switched to PF-06823859 150 mg IV at Week 12	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 1	19.50 Units on a scale	Standard Deviation 0.707
(Amended Stage 2) Placebo Then Switched to PF-06823859 150 mg IV at Week 12	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 8	23.50 Units on a scale	Standard Deviation 2.121
(Amended Stage 2) Placebo Then Switched to PF-06823859 150 mg IV at Week 12	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 12	23.00 Units on a scale	Standard Deviation 2.828
(Amended Stage 2) Placebo Then Switched to PF-06823859 600 mg IV at Week 12	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 4	36.00 Units on a scale	—
(Amended Stage 2) Placebo Then Switched to PF-06823859 600 mg IV at Week 12	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 12	40.00 Units on a scale	—
(Amended Stage 2) Placebo Then Switched to PF-06823859 600 mg IV at Week 12	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 1	37.00 Units on a scale	—
(Amended Stage 2) Placebo Then Switched to PF-06823859 600 mg IV at Week 12	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Baseline	37.00 Units on a scale	—
(Amended Stage 2) Placebo Then Switched to PF-06823859 600 mg IV at Week 12	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 8	35.00 Units on a scale	—
(Amended Stage 2) PF-06823859 150 mg IV Then Switched to Placebo at Week 12	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 4	21.00 Units on a scale	Standard Deviation 10.677
(Amended Stage 2) PF-06823859 150 mg IV Then Switched to Placebo at Week 12	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Baseline	35.40 Units on a scale	Standard Deviation 13.226
(Amended Stage 2) PF-06823859 150 mg IV Then Switched to Placebo at Week 12	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 12	19.00 Units on a scale	Standard Deviation 14.087
(Amended Stage 2) PF-06823859 150 mg IV Then Switched to Placebo at Week 12	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 8	17.60 Units on a scale	Standard Deviation 10.895
(Amended Stage 2) PF-06823859 150 mg IV Then Switched to Placebo at Week 12	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 1	26.70 Units on a scale	Standard Deviation 12.667
(Amended Stage 2) PF-06823859 600 mg IV Then Switched to Placebo at Week 12	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 4	16.00 Units on a scale	Standard Deviation 9.539
(Amended Stage 2) PF-06823859 600 mg IV Then Switched to Placebo at Week 12	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 1	23.33 Units on a scale	Standard Deviation 9.018
(Amended Stage 2) PF-06823859 600 mg IV Then Switched to Placebo at Week 12	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 8	16.00 Units on a scale	Standard Deviation 11.269
(Amended Stage 2) PF-06823859 600 mg IV Then Switched to Placebo at Week 12	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Baseline	30.00 Units on a scale	Standard Deviation 7.937
(Amended Stage 2) PF-06823859 600 mg IV Then Switched to Placebo at Week 12	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 12	14.67 Units on a scale	Standard Deviation 9.504
(Stage 3) Placebo Then Switched to PF-06823859 600 mg IV at Week 12	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Baseline	17.22 Units on a scale	Standard Deviation 11.595
(Stage 3) Placebo Then Switched to PF-06823859 600 mg IV at Week 12	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 8	12.22 Units on a scale	Standard Deviation 10.883
(Stage 3) Placebo Then Switched to PF-06823859 600 mg IV at Week 12	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 12	11.33 Units on a scale	Standard Deviation 9.206
(Stage 3) Placebo Then Switched to PF-06823859 600 mg IV at Week 12	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 1	15.22 Units on a scale	Standard Deviation 9.846
(Stage 3) Placebo Then Switched to PF-06823859 600 mg IV at Week 12	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 4	13.44 Units on a scale	Standard Deviation 8.819
(Stage 3) PF-06823859 600 mg IV Then Switched to Placebo at Week 12	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 8	4.78 Units on a scale	Standard Deviation 4.116
(Stage 3) PF-06823859 600 mg IV Then Switched to Placebo at Week 12	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 4	7.44 Units on a scale	Standard Deviation 5.503
(Stage 3) PF-06823859 600 mg IV Then Switched to Placebo at Week 12	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 1	10.44 Units on a scale	Standard Deviation 6.894
(Stage 3) PF-06823859 600 mg IV Then Switched to Placebo at Week 12	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Baseline	12.56 Units on a scale	Standard Deviation 8.095
(Stage 3) PF-06823859 600 mg IV Then Switched to Placebo at Week 12	Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 12	4.00 Units on a scale	Standard Deviation 3.464

Secondary

Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)

The Damage Score (DS) was calculated as a sum of the total poilkiloderma score (POLS), total calcinosis score (CALS) and Gotorn's hands damage score (GHDS). The POLS characterizes specific dispigmentation in the particulal area and calcinosis score characterizes calcification of the skin in the particular area. The POLS and the CALS are summed up over 15 individual areas in the body and each of them has range 0-15. The GHDS has the range 0-2 so that the DS has the range 0-32. Higher scores indicate greater disease severity.

Time frame: Baseline, Week 1, Week 4, Week 8 and Week 12

Population: The FAS included all participants who received at least 1 dose of randomized treatment in any study stage.

Arm	Measure	Group	Value (MEAN)	Dispersion
(Stage 1) Placebo	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 12	6.33 Units on a scale	Standard Deviation 5.679
(Stage 1) Placebo	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 1	4.90 Units on a scale	Standard Deviation 5.021
(Stage 1) Placebo	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Baseline	4.30 Units on a scale	Standard Deviation 5.397
(Stage 1) Placebo	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 4	5.11 Units on a scale	Standard Deviation 5.278
(Stage 1) Placebo	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 8	5.89 Units on a scale	Standard Deviation 5.231
PF-06823859 600 mg IV (Stage 1)	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Baseline	5.50 Units on a scale	Standard Deviation 3.901
PF-06823859 600 mg IV (Stage 1)	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 8	5.00 Units on a scale	Standard Deviation 4.427
PF-06823859 600 mg IV (Stage 1)	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 1	5.41 Units on a scale	Standard Deviation 4.159
PF-06823859 600 mg IV (Stage 1)	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 4	5.23 Units on a scale	Standard Deviation 3.337
PF-06823859 600 mg IV (Stage 1)	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 12	5.05 Units on a scale	Standard Deviation 3.905
(Stage 2) Placebo	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 4	4.00 Units on a scale	—
(Stage 2) Placebo	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 12	6.00 Units on a scale	—
(Stage 2) Placebo	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 1	4.00 Units on a scale	—
(Stage 2) Placebo	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Baseline	3.00 Units on a scale	—
(Stage 2) Placebo	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 8	5.00 Units on a scale	—
(Stage 2) PF-06823859 150 mg IV	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 8	4.40 Units on a scale	Standard Deviation 2.881
(Stage 2) PF-06823859 150 mg IV	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 4	3.00 Units on a scale	Standard Deviation 2.449
(Stage 2) PF-06823859 150 mg IV	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 12	3.60 Units on a scale	Standard Deviation 3.286
(Stage 2) PF-06823859 150 mg IV	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Baseline	4.20 Units on a scale	Standard Deviation 3.701
(Stage 2) PF-06823859 150 mg IV	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 1	3.80 Units on a scale	Standard Deviation 3.347
(Stage 2) PF-06823859 600 mg IV	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 12	6.33 Units on a scale	Standard Deviation 1.528
(Stage 2) PF-06823859 600 mg IV	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 4	9.00 Units on a scale	Standard Deviation 1.732
(Stage 2) PF-06823859 600 mg IV	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 8	8.33 Units on a scale	Standard Deviation 0.577
(Stage 2) PF-06823859 600 mg IV	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 1	6.33 Units on a scale	Standard Deviation 3.215
(Stage 2) PF-06823859 600 mg IV	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Baseline	7.00 Units on a scale	Standard Deviation 1.732
(Amended Stage 2) Placebo Then Switched to PF-06823859 150 mg IV at Week 12	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 4	7.00 Units on a scale	Standard Deviation 5.657
(Amended Stage 2) Placebo Then Switched to PF-06823859 150 mg IV at Week 12	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Baseline	7.50 Units on a scale	Standard Deviation 4.95
(Amended Stage 2) Placebo Then Switched to PF-06823859 150 mg IV at Week 12	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 1	6.00 Units on a scale	Standard Deviation 7.071
(Amended Stage 2) Placebo Then Switched to PF-06823859 150 mg IV at Week 12	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 8	5.50 Units on a scale	Standard Deviation 3.536
(Amended Stage 2) Placebo Then Switched to PF-06823859 150 mg IV at Week 12	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 12	4.50 Units on a scale	Standard Deviation 4.95
(Amended Stage 2) Placebo Then Switched to PF-06823859 600 mg IV at Week 12	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 4	7.00 Units on a scale	—
(Amended Stage 2) Placebo Then Switched to PF-06823859 600 mg IV at Week 12	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 12	7.00 Units on a scale	—
(Amended Stage 2) Placebo Then Switched to PF-06823859 600 mg IV at Week 12	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 1	7.00 Units on a scale	—
(Amended Stage 2) Placebo Then Switched to PF-06823859 600 mg IV at Week 12	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Baseline	7.00 Units on a scale	—
(Amended Stage 2) Placebo Then Switched to PF-06823859 600 mg IV at Week 12	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 8	7.00 Units on a scale	—
(Amended Stage 2) PF-06823859 150 mg IV Then Switched to Placebo at Week 12	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 4	4.40 Units on a scale	Standard Deviation 4.248
(Amended Stage 2) PF-06823859 150 mg IV Then Switched to Placebo at Week 12	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Baseline	4.70 Units on a scale	Standard Deviation 4.373
(Amended Stage 2) PF-06823859 150 mg IV Then Switched to Placebo at Week 12	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 12	3.10 Units on a scale	Standard Deviation 4.358
(Amended Stage 2) PF-06823859 150 mg IV Then Switched to Placebo at Week 12	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 8	3.70 Units on a scale	Standard Deviation 3.945
(Amended Stage 2) PF-06823859 150 mg IV Then Switched to Placebo at Week 12	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 1	3.90 Units on a scale	Standard Deviation 3.542
(Amended Stage 2) PF-06823859 600 mg IV Then Switched to Placebo at Week 12	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 4	6.33 Units on a scale	Standard Deviation 1.528
(Amended Stage 2) PF-06823859 600 mg IV Then Switched to Placebo at Week 12	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 1	4.67 Units on a scale	Standard Deviation 2.887
(Amended Stage 2) PF-06823859 600 mg IV Then Switched to Placebo at Week 12	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 8	4.67 Units on a scale	Standard Deviation 3.215
(Amended Stage 2) PF-06823859 600 mg IV Then Switched to Placebo at Week 12	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Baseline	7.00 Units on a scale	Standard Deviation 3
(Amended Stage 2) PF-06823859 600 mg IV Then Switched to Placebo at Week 12	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 12	5.00 Units on a scale	Standard Deviation 1
(Stage 3) Placebo Then Switched to PF-06823859 600 mg IV at Week 12	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Baseline	5.56 Units on a scale	Standard Deviation 6.044
(Stage 3) Placebo Then Switched to PF-06823859 600 mg IV at Week 12	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 8	5.11 Units on a scale	Standard Deviation 4.859
(Stage 3) Placebo Then Switched to PF-06823859 600 mg IV at Week 12	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 12	5.22 Units on a scale	Standard Deviation 5.019
(Stage 3) Placebo Then Switched to PF-06823859 600 mg IV at Week 12	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 1	6.00 Units on a scale	Standard Deviation 5.809
(Stage 3) Placebo Then Switched to PF-06823859 600 mg IV at Week 12	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 4	5.22 Units on a scale	Standard Deviation 4.631
(Stage 3) PF-06823859 600 mg IV Then Switched to Placebo at Week 12	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 8	1.00 Units on a scale	Standard Deviation 1.118
(Stage 3) PF-06823859 600 mg IV Then Switched to Placebo at Week 12	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 4	1.56 Units on a scale	Standard Deviation 2.297
(Stage 3) PF-06823859 600 mg IV Then Switched to Placebo at Week 12	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 1	1.89 Units on a scale	Standard Deviation 1.764
(Stage 3) PF-06823859 600 mg IV Then Switched to Placebo at Week 12	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Baseline	2.00 Units on a scale	Standard Deviation 1.871
(Stage 3) PF-06823859 600 mg IV Then Switched to Placebo at Week 12	Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)	Week 12	1.33 Units on a scale	Standard Deviation 1.581

Secondary

Change From Baseline in CDASI Activity Score at All Scheduled Timepoints Through Week 12 (Stage 3)

The treatment effect was defined as the difference (mean change from baseline at Weeks 1, 4, 8,12 in the active treatment group minus the mean change from baseline at Weeks 1, 4, 8, 12 in the placebo group) in the mean change of CDASI activity score from baseline at scheduled timepoints. The score (range: 0-100) consists of the ES, GHS, PS and 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.

Time frame: Baseline, Week 1, Week 4, Week 8 and Week 12

Population: The Full Analysis Set in Stage 3 (FAS3) included all participants who received at least 1 dose of randomized treatment in Stage 3.

Arm	Measure	Group	Value (MEAN)	Dispersion
(Stage 1) Placebo	Change From Baseline in CDASI Activity Score at All Scheduled Timepoints Through Week 12 (Stage 3)	Week 1	-2.00 Units on a scale	Standard Deviation 3.808
(Stage 1) Placebo	Change From Baseline in CDASI Activity Score at All Scheduled Timepoints Through Week 12 (Stage 3)	Week 4	-3.78 Units on a scale	Standard Deviation 5.333
(Stage 1) Placebo	Change From Baseline in CDASI Activity Score at All Scheduled Timepoints Through Week 12 (Stage 3)	Week 8	-5.00 Units on a scale	Standard Deviation 7.382
(Stage 1) Placebo	Change From Baseline in CDASI Activity Score at All Scheduled Timepoints Through Week 12 (Stage 3)	Week 12	-5.89 Units on a scale	Standard Deviation 8.177
PF-06823859 600 mg IV (Stage 1)	Change From Baseline in CDASI Activity Score at All Scheduled Timepoints Through Week 12 (Stage 3)	Week 12	-8.56 Units on a scale	Standard Deviation 7.923
PF-06823859 600 mg IV (Stage 1)	Change From Baseline in CDASI Activity Score at All Scheduled Timepoints Through Week 12 (Stage 3)	Week 1	-2.11 Units on a scale	Standard Deviation 2.522
PF-06823859 600 mg IV (Stage 1)	Change From Baseline in CDASI Activity Score at All Scheduled Timepoints Through Week 12 (Stage 3)	Week 8	-7.78 Units on a scale	Standard Deviation 6.667
PF-06823859 600 mg IV (Stage 1)	Change From Baseline in CDASI Activity Score at All Scheduled Timepoints Through Week 12 (Stage 3)	Week 4	-5.11 Units on a scale	Standard Deviation 5.555

Secondary

Change From Baseline in CDASI Activity Score at at All Scheduled Timepoints Through Week 12 (Stage 1, Stage 2 and Amended Stage 2)

The treatment effect was defined as the difference (mean change from baseline at Weeks 1, 4, 8 in the active treatment group minus the mean change from baseline at Weeks 1, 4, 8 in the placebo group) in the mean change of CDASI activity score from baseline at scheduled timepoints. The score (range: 0-100) consists of the ES, GHS, PS and 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.

Time frame: Baseline, Week 1, Week 4, and Week 8 (except for Week 12 which is a primary outcome measure)

Population: The 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
(Stage 1) Placebo	Change From Baseline in CDASI Activity Score at at All Scheduled Timepoints Through Week 12 (Stage 1, Stage 2 and Amended Stage 2)	Week 1	-2.60 Units on a scale	Standard Deviation 4.326
(Stage 1) Placebo	Change From Baseline in CDASI Activity Score at at All Scheduled Timepoints Through Week 12 (Stage 1, Stage 2 and Amended Stage 2)	Week 8	-4.22 Units on a scale	Standard Deviation 6.942
(Stage 1) Placebo	Change From Baseline in CDASI Activity Score at at All Scheduled Timepoints Through Week 12 (Stage 1, Stage 2 and Amended Stage 2)	Week 4	-2.44 Units on a scale	Standard Deviation 8.126
PF-06823859 600 mg IV (Stage 1)	Change From Baseline in CDASI Activity Score at at All Scheduled Timepoints Through Week 12 (Stage 1, Stage 2 and Amended Stage 2)	Week 8	-17.19 Units on a scale	Standard Deviation 9.595
PF-06823859 600 mg IV (Stage 1)	Change From Baseline in CDASI Activity Score at at All Scheduled Timepoints Through Week 12 (Stage 1, Stage 2 and Amended Stage 2)	Week 4	-12.00 Units on a scale	Standard Deviation 10.277
PF-06823859 600 mg IV (Stage 1)	Change From Baseline in CDASI Activity Score at at All Scheduled Timepoints Through Week 12 (Stage 1, Stage 2 and Amended Stage 2)	Week 1	-19.62 Units on a scale	Standard Deviation 9.14
(Stage 2) Placebo	Change From Baseline in CDASI Activity Score at at All Scheduled Timepoints Through Week 12 (Stage 1, Stage 2 and Amended Stage 2)	Week 4	3.00 Units on a scale	—
(Stage 2) Placebo	Change From Baseline in CDASI Activity Score at at All Scheduled Timepoints Through Week 12 (Stage 1, Stage 2 and Amended Stage 2)	Week 1	1.00 Units on a scale	—
(Stage 2) Placebo	Change From Baseline in CDASI Activity Score at at All Scheduled Timepoints Through Week 12 (Stage 1, Stage 2 and Amended Stage 2)	Week 8	4.00 Units on a scale	—
(Stage 2) PF-06823859 150 mg IV	Change From Baseline in CDASI Activity Score at at All Scheduled Timepoints Through Week 12 (Stage 1, Stage 2 and Amended Stage 2)	Week 8	-14.20 Units on a scale	Standard Deviation 5.02
(Stage 2) PF-06823859 150 mg IV	Change From Baseline in CDASI Activity Score at at All Scheduled Timepoints Through Week 12 (Stage 1, Stage 2 and Amended Stage 2)	Week 1	-9.80 Units on a scale	Standard Deviation 12.174
(Stage 2) PF-06823859 150 mg IV	Change From Baseline in CDASI Activity Score at at All Scheduled Timepoints Through Week 12 (Stage 1, Stage 2 and Amended Stage 2)	Week 4	-11.20 Units on a scale	Standard Deviation 10.986
(Stage 2) PF-06823859 600 mg IV	Change From Baseline in CDASI Activity Score at at All Scheduled Timepoints Through Week 12 (Stage 1, Stage 2 and Amended Stage 2)	Week 4	-15.00 Units on a scale	Standard Deviation 7.55
(Stage 2) PF-06823859 600 mg IV	Change From Baseline in CDASI Activity Score at at All Scheduled Timepoints Through Week 12 (Stage 1, Stage 2 and Amended Stage 2)	Week 1	-2.33 Units on a scale	Standard Deviation 1.528
(Stage 2) PF-06823859 600 mg IV	Change From Baseline in CDASI Activity Score at at All Scheduled Timepoints Through Week 12 (Stage 1, Stage 2 and Amended Stage 2)	Week 8	-18.67 Units on a scale	Standard Deviation 10.066
(Amended Stage 2) Placebo Then Switched to PF-06823859 150 mg IV at Week 12	Change From Baseline in CDASI Activity Score at at All Scheduled Timepoints Through Week 12 (Stage 1, Stage 2 and Amended Stage 2)	Week 4	-3.00 Units on a scale	Standard Deviation 7.071
(Amended Stage 2) Placebo Then Switched to PF-06823859 150 mg IV at Week 12	Change From Baseline in CDASI Activity Score at at All Scheduled Timepoints Through Week 12 (Stage 1, Stage 2 and Amended Stage 2)	Week 1	-6.50 Units on a scale	Standard Deviation 6.364
(Amended Stage 2) Placebo Then Switched to PF-06823859 150 mg IV at Week 12	Change From Baseline in CDASI Activity Score at at All Scheduled Timepoints Through Week 12 (Stage 1, Stage 2 and Amended Stage 2)	Week 8	-2.50 Units on a scale	Standard Deviation 7.778
(Amended Stage 2) Placebo Then Switched to PF-06823859 600 mg IV at Week 12	Change From Baseline in CDASI Activity Score at at All Scheduled Timepoints Through Week 12 (Stage 1, Stage 2 and Amended Stage 2)	Week 8	-2.00 Units on a scale	—
(Amended Stage 2) Placebo Then Switched to PF-06823859 600 mg IV at Week 12	Change From Baseline in CDASI Activity Score at at All Scheduled Timepoints Through Week 12 (Stage 1, Stage 2 and Amended Stage 2)	Week 1	0.00 Units on a scale	—
(Amended Stage 2) Placebo Then Switched to PF-06823859 600 mg IV at Week 12	Change From Baseline in CDASI Activity Score at at All Scheduled Timepoints Through Week 12 (Stage 1, Stage 2 and Amended Stage 2)	Week 4	-1.00 Units on a scale	—
(Amended Stage 2) PF-06823859 150 mg IV Then Switched to Placebo at Week 12	Change From Baseline in CDASI Activity Score at at All Scheduled Timepoints Through Week 12 (Stage 1, Stage 2 and Amended Stage 2)	Week 4	-14.40 Units on a scale	Standard Deviation 7.648
(Amended Stage 2) PF-06823859 150 mg IV Then Switched to Placebo at Week 12	Change From Baseline in CDASI Activity Score at at All Scheduled Timepoints Through Week 12 (Stage 1, Stage 2 and Amended Stage 2)	Week 8	-17.80 Units on a scale	Standard Deviation 7.54
(Amended Stage 2) PF-06823859 150 mg IV Then Switched to Placebo at Week 12	Change From Baseline in CDASI Activity Score at at All Scheduled Timepoints Through Week 12 (Stage 1, Stage 2 and Amended Stage 2)	Week 1	-8.70 Units on a scale	Standard Deviation 5.638
(Amended Stage 2) PF-06823859 600 mg IV Then Switched to Placebo at Week 12	Change From Baseline in CDASI Activity Score at at All Scheduled Timepoints Through Week 12 (Stage 1, Stage 2 and Amended Stage 2)	Week 4	-14.00 Units on a scale	Standard Deviation 2
(Amended Stage 2) PF-06823859 600 mg IV Then Switched to Placebo at Week 12	Change From Baseline in CDASI Activity Score at at All Scheduled Timepoints Through Week 12 (Stage 1, Stage 2 and Amended Stage 2)	Week 8	-14.00 Units on a scale	Standard Deviation 4
(Amended Stage 2) PF-06823859 600 mg IV Then Switched to Placebo at Week 12	Change From Baseline in CDASI Activity Score at at All Scheduled Timepoints Through Week 12 (Stage 1, Stage 2 and Amended Stage 2)	Week 1	-6.67 Units on a scale	Standard Deviation 2.517

Secondary

Change From Baseline in the Core Set Measures (CSM) of the TIS (Global Disease Activity [PhGA] and Extramuscular Global Assessment [EmGA]) (Stage 3)

PhGA: assessment of the severity of disease by the physician. The physician used the visual analog scale and put a mark on 0 cm (best) -10 cm (worst) scale where higher score indicated worse status. EmGA: overall evaluation of disease activity in all extramuscular systems using visual analog scale 0 cm (best) -10 cm (worst) scale where higher score indicated worse status.

Time frame: Baseline, Week 4, Week 8 and Week 12

Population: The Full Analysis Set in Stage 3 (FAS3) included all participants who received at least 1 dose of randomized treatment in Stage 3.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)
(Stage 1) Placebo	Change From Baseline in the Core Set Measures (CSM) of the TIS (Global Disease Activity [PhGA] and Extramuscular Global Assessment [EmGA]) (Stage 3)	PhGA Week 4	-1.00 Centimeter (cm)
(Stage 1) Placebo	Change From Baseline in the Core Set Measures (CSM) of the TIS (Global Disease Activity [PhGA] and Extramuscular Global Assessment [EmGA]) (Stage 3)	PhGA Week 8	-1.65 Centimeter (cm)
(Stage 1) Placebo	Change From Baseline in the Core Set Measures (CSM) of the TIS (Global Disease Activity [PhGA] and Extramuscular Global Assessment [EmGA]) (Stage 3)	PhGA Week 12	-2.05 Centimeter (cm)
(Stage 1) Placebo	Change From Baseline in the Core Set Measures (CSM) of the TIS (Global Disease Activity [PhGA] and Extramuscular Global Assessment [EmGA]) (Stage 3)	Extramuscular Global Assessment Week 4	-1.02 Centimeter (cm)
(Stage 1) Placebo	Change From Baseline in the Core Set Measures (CSM) of the TIS (Global Disease Activity [PhGA] and Extramuscular Global Assessment [EmGA]) (Stage 3)	Extramuscular Global Assessment Week 8	-1.91 Centimeter (cm)
(Stage 1) Placebo	Change From Baseline in the Core Set Measures (CSM) of the TIS (Global Disease Activity [PhGA] and Extramuscular Global Assessment [EmGA]) (Stage 3)	Extramuscular Global Assessment Week 12	-1.59 Centimeter (cm)
PF-06823859 600 mg IV (Stage 1)	Change From Baseline in the Core Set Measures (CSM) of the TIS (Global Disease Activity [PhGA] and Extramuscular Global Assessment [EmGA]) (Stage 3)	Extramuscular Global Assessment Week 8	-2.48 Centimeter (cm)
PF-06823859 600 mg IV (Stage 1)	Change From Baseline in the Core Set Measures (CSM) of the TIS (Global Disease Activity [PhGA] and Extramuscular Global Assessment [EmGA]) (Stage 3)	PhGA Week 4	-1.68 Centimeter (cm)
PF-06823859 600 mg IV (Stage 1)	Change From Baseline in the Core Set Measures (CSM) of the TIS (Global Disease Activity [PhGA] and Extramuscular Global Assessment [EmGA]) (Stage 3)	Extramuscular Global Assessment Week 4	-1.55 Centimeter (cm)
PF-06823859 600 mg IV (Stage 1)	Change From Baseline in the Core Set Measures (CSM) of the TIS (Global Disease Activity [PhGA] and Extramuscular Global Assessment [EmGA]) (Stage 3)	PhGA Week 8	-2.76 Centimeter (cm)
PF-06823859 600 mg IV (Stage 1)	Change From Baseline in the Core Set Measures (CSM) of the TIS (Global Disease Activity [PhGA] and Extramuscular Global Assessment [EmGA]) (Stage 3)	Extramuscular Global Assessment Week 12	-2.81 Centimeter (cm)
PF-06823859 600 mg IV (Stage 1)	Change From Baseline in the Core Set Measures (CSM) of the TIS (Global Disease Activity [PhGA] and Extramuscular Global Assessment [EmGA]) (Stage 3)	PhGA Week 12	-3.40 Centimeter (cm)

Secondary

Change From Baseline in the CSM of the TIS (Aldolase and Creatine Kinase) (Stage 3)

The LS mean (with 90% CI) of CSM of the TIS (aldolase and creatine kinase) at weeks 4, 8, 12 were presented.

Time frame: Baseline, Week 4, Week 8 and Week 12

Population: The FAS3 included all participants who received at least 1 dose of randomized treatment in Stage 3.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)
(Stage 1) Placebo	Change From Baseline in the CSM of the TIS (Aldolase and Creatine Kinase) (Stage 3)	Aldolase Week 4	-0.19 Units per litre (U/L)
(Stage 1) Placebo	Change From Baseline in the CSM of the TIS (Aldolase and Creatine Kinase) (Stage 3)	Aldolase Week 8	-1.31 Units per litre (U/L)
(Stage 1) Placebo	Change From Baseline in the CSM of the TIS (Aldolase and Creatine Kinase) (Stage 3)	Aldolase Week 12	-0.66 Units per litre (U/L)
(Stage 1) Placebo	Change From Baseline in the CSM of the TIS (Aldolase and Creatine Kinase) (Stage 3)	Creatine Kinase Week 4	-37.96 Units per litre (U/L)
(Stage 1) Placebo	Change From Baseline in the CSM of the TIS (Aldolase and Creatine Kinase) (Stage 3)	Creatine Kinase Week 8	-70.96 Units per litre (U/L)
(Stage 1) Placebo	Change From Baseline in the CSM of the TIS (Aldolase and Creatine Kinase) (Stage 3)	Creatine Kinase ) Week 12	-39.85 Units per litre (U/L)
PF-06823859 600 mg IV (Stage 1)	Change From Baseline in the CSM of the TIS (Aldolase and Creatine Kinase) (Stage 3)	Creatine Kinase Week 8	-175.93 Units per litre (U/L)
PF-06823859 600 mg IV (Stage 1)	Change From Baseline in the CSM of the TIS (Aldolase and Creatine Kinase) (Stage 3)	Aldolase Week 4	-3.09 Units per litre (U/L)
PF-06823859 600 mg IV (Stage 1)	Change From Baseline in the CSM of the TIS (Aldolase and Creatine Kinase) (Stage 3)	Creatine Kinase Week 4	-157.48 Units per litre (U/L)
PF-06823859 600 mg IV (Stage 1)	Change From Baseline in the CSM of the TIS (Aldolase and Creatine Kinase) (Stage 3)	Aldolase Week 8	-3.57 Units per litre (U/L)
PF-06823859 600 mg IV (Stage 1)	Change From Baseline in the CSM of the TIS (Aldolase and Creatine Kinase) (Stage 3)	Creatine Kinase ) Week 12	-185.77 Units per litre (U/L)
PF-06823859 600 mg IV (Stage 1)	Change From Baseline in the CSM of the TIS (Aldolase and Creatine Kinase) (Stage 3)	Aldolase Week 12	-3.20 Units per litre (U/L)

Secondary

Change From Baseline in the CSM of the TIS (MMT8 and HAQ01-HAQ-DI) (Stage 3)

Manual Muscle Testing-8 designated muscle groups (MMT-8): was a set of 8 designated muscles tested unilaterally generally on right side (left side used unless right side cannot be used). Potential score range was from 0 to 80, where higher scores denoted better health status. HAQ-DI: contained eight sections (including dressing & grooming, arising, eating, walking, hygiene, grip, reach, and activities). Each section had multiple questions that the participant used to rank their functionality and ranged from 0 to 3 where 0 = without any difficulty and 3 = unable to do. For each participant, the average ranking was calculated for each of the eight sections. HAQ-DI had a score range of 0 to 3, where higher score reflected worse status.

Time frame: Week 4, Week 8 and Week 12

Population: The FAS3 included all participants who received at least 1 dose of randomized treatment in Stage 3.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)
(Stage 1) Placebo	Change From Baseline in the CSM of the TIS (MMT8 and HAQ01-HAQ-DI) (Stage 3)	MMT8 - Derived Week 4	7.76 Units on a scale
(Stage 1) Placebo	Change From Baseline in the CSM of the TIS (MMT8 and HAQ01-HAQ-DI) (Stage 3)	MMT8 - Derived Week 8	12.14 Units on a scale
(Stage 1) Placebo	Change From Baseline in the CSM of the TIS (MMT8 and HAQ01-HAQ-DI) (Stage 3)	MMT8 - Derived Week 12	11.65 Units on a scale
(Stage 1) Placebo	Change From Baseline in the CSM of the TIS (MMT8 and HAQ01-HAQ-DI) (Stage 3)	HAQ01-HAQ-DI Week 4	-0.03 Units on a scale
(Stage 1) Placebo	Change From Baseline in the CSM of the TIS (MMT8 and HAQ01-HAQ-DI) (Stage 3)	HAQ01-HAQ-DI Week 8	0.00 Units on a scale
(Stage 1) Placebo	Change From Baseline in the CSM of the TIS (MMT8 and HAQ01-HAQ-DI) (Stage 3)	HAQ01-HAQ-DI Week 12	-0.06 Units on a scale
PF-06823859 600 mg IV (Stage 1)	Change From Baseline in the CSM of the TIS (MMT8 and HAQ01-HAQ-DI) (Stage 3)	HAQ01-HAQ-DI Week 8	-0.38 Units on a scale
PF-06823859 600 mg IV (Stage 1)	Change From Baseline in the CSM of the TIS (MMT8 and HAQ01-HAQ-DI) (Stage 3)	MMT8 - Derived Week 4	8.24 Units on a scale
PF-06823859 600 mg IV (Stage 1)	Change From Baseline in the CSM of the TIS (MMT8 and HAQ01-HAQ-DI) (Stage 3)	HAQ01-HAQ-DI Week 4	-0.20 Units on a scale
PF-06823859 600 mg IV (Stage 1)	Change From Baseline in the CSM of the TIS (MMT8 and HAQ01-HAQ-DI) (Stage 3)	MMT8 - Derived Week 8	15.24 Units on a scale
PF-06823859 600 mg IV (Stage 1)	Change From Baseline in the CSM of the TIS (MMT8 and HAQ01-HAQ-DI) (Stage 3)	HAQ01-HAQ-DI Week 12	-0.52 Units on a scale
PF-06823859 600 mg IV (Stage 1)	Change From Baseline in the CSM of the TIS (MMT8 and HAQ01-HAQ-DI) (Stage 3)	MMT8 - Derived Week 12	21.24 Units on a scale

Secondary

Change From Baseline in the CSM of the TIS (PtGA) (Stage 3)

PtGA: assessment of the severity of disease by the participant/participant's guardian, using a visual analog scale from 0 mm (no evidence of disease activity) to 100 mm (extremely active or severe disease activity). Higher score indicated worse status.

Time frame: Baseline, Week 4, Week 8 and Week 12

Population: The FAS3 included all participants who received at least 1 dose of randomized treatment in Stage 3.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)
(Stage 1) Placebo	Change From Baseline in the CSM of the TIS (PtGA) (Stage 3)	PtGA Week 4	-18.29 Millimeter (mm)
(Stage 1) Placebo	Change From Baseline in the CSM of the TIS (PtGA) (Stage 3)	PtGA Week 8	-16.81 Millimeter (mm)
(Stage 1) Placebo	Change From Baseline in the CSM of the TIS (PtGA) (Stage 3)	PtGA Week 12	-14.04 Millimeter (mm)
PF-06823859 600 mg IV (Stage 1)	Change From Baseline in the CSM of the TIS (PtGA) (Stage 3)	PtGA Week 12	-43.81 Millimeter (mm)
PF-06823859 600 mg IV (Stage 1)	Change From Baseline in the CSM of the TIS (PtGA) (Stage 3)	PtGA Week 4	-17.88 Millimeter (mm)
PF-06823859 600 mg IV (Stage 1)	Change From Baseline in the CSM of the TIS (PtGA) (Stage 3)	PtGA Week 8	-32.60 Millimeter (mm)

Secondary

Number of Participants With Clinically Significant Laboratory Abnormalities (Amended Stage 2)

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.

Time frame: Up to Week 40

Population: The SASA2 includes all participants who received at least one dose of randomized treatment in Amended Stage 2.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
(Stage 1) Placebo	Number of Participants With Clinically Significant Laboratory Abnormalities (Amended Stage 2)	0 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With Clinically Significant Laboratory Abnormalities (Amended Stage 2)	0 Participants
(Stage 2) Placebo	Number of Participants With Clinically Significant Laboratory Abnormalities (Amended Stage 2)	0 Participants
(Stage 2) PF-06823859 150 mg IV	Number of Participants With Clinically Significant Laboratory Abnormalities (Amended Stage 2)	0 Participants

Secondary

Number of Participants With Clinically Significant Laboratory Abnormalities (Stage 1 and Stage 2)

Time frame: Up to Week 28

Population: The SAS1 and SAS2 included all participants who received at least 1 dose of randomized treatment in Stage 1 and Stage 2, respectively.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
(Stage 1) Placebo	Number of Participants With Clinically Significant Laboratory Abnormalities (Stage 1 and Stage 2)	0 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With Clinically Significant Laboratory Abnormalities (Stage 1 and Stage 2)	0 Participants
(Stage 2) Placebo	Number of Participants With Clinically Significant Laboratory Abnormalities (Stage 1 and Stage 2)	0 Participants
(Stage 2) PF-06823859 150 mg IV	Number of Participants With Clinically Significant Laboratory Abnormalities (Stage 1 and Stage 2)	0 Participants
(Stage 2) PF-06823859 600 mg IV	Number of Participants With Clinically Significant Laboratory Abnormalities (Stage 1 and Stage 2)	0 Participants

Secondary

Number of Participants With ECG Abnormalities (Amended Stage 2)

Time frame: Up to Week 40

Population: The SASA2 includes all participants who received at least one dose of randomized treatment in Amended Stage 2.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
(Stage 1) Placebo	Number of Participants With ECG Abnormalities (Amended Stage 2)	QRS Duration %Chg >=25% or >=50%	0 Participants
(Stage 1) Placebo	Number of Participants With ECG Abnormalities (Amended Stage 2)	QRS Duration Aggregate Value >=200 msec	0 Participants
(Stage 1) Placebo	Number of Participants With ECG Abnormalities (Amended Stage 2)	QTcF Interval Aggregate 480<=Value<500 msec	0 Participants
(Stage 1) Placebo	Number of Participants With ECG Abnormalities (Amended Stage 2)	QTcF Interval Aggregate 450<=Value<480 msec	1 Participants
(Stage 1) Placebo	Number of Participants With ECG Abnormalities (Amended Stage 2)	QT Interval Aggregate Value >=500 msec	0 Participants
(Stage 1) Placebo	Number of Participants With ECG Abnormalities (Amended Stage 2)	PR Interval Aggregate Value >=300 msec	0 Participants
(Stage 1) Placebo	Number of Participants With ECG Abnormalities (Amended Stage 2)	QTcF Chg (msec) >=60	0 Participants
(Stage 1) Placebo	Number of Participants With ECG Abnormalities (Amended Stage 2)	30<=QTcF Chg (msec)<60	1 Participants
(Stage 1) Placebo	Number of Participants With ECG Abnormalities (Amended Stage 2)	PR %Chg >=25% or >=50%	0 Participants
(Stage 1) Placebo	Number of Participants With ECG Abnormalities (Amended Stage 2)	QTcF Interval Aggregate Value >=500 msec	0 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With ECG Abnormalities (Amended Stage 2)	QRS Duration %Chg >=25% or >=50%	0 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With ECG Abnormalities (Amended Stage 2)	PR Interval Aggregate Value >=300 msec	0 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With ECG Abnormalities (Amended Stage 2)	30<=QTcF Chg (msec)<60	0 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With ECG Abnormalities (Amended Stage 2)	QTcF Chg (msec) >=60	0 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With ECG Abnormalities (Amended Stage 2)	QT Interval Aggregate Value >=500 msec	0 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With ECG Abnormalities (Amended Stage 2)	QTcF Interval Aggregate 450<=Value<480 msec	0 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With ECG Abnormalities (Amended Stage 2)	QTcF Interval Aggregate 480<=Value<500 msec	0 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With ECG Abnormalities (Amended Stage 2)	QTcF Interval Aggregate Value >=500 msec	0 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With ECG Abnormalities (Amended Stage 2)	QRS Duration Aggregate Value >=200 msec	0 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With ECG Abnormalities (Amended Stage 2)	PR %Chg >=25% or >=50%	0 Participants
(Stage 2) Placebo	Number of Participants With ECG Abnormalities (Amended Stage 2)	QT Interval Aggregate Value >=500 msec	0 Participants
(Stage 2) Placebo	Number of Participants With ECG Abnormalities (Amended Stage 2)	QRS Duration %Chg >=25% or >=50%	0 Participants
(Stage 2) Placebo	Number of Participants With ECG Abnormalities (Amended Stage 2)	PR %Chg >=25% or >=50%	0 Participants
(Stage 2) Placebo	Number of Participants With ECG Abnormalities (Amended Stage 2)	QTcF Interval Aggregate Value >=500 msec	0 Participants
(Stage 2) Placebo	Number of Participants With ECG Abnormalities (Amended Stage 2)	QRS Duration Aggregate Value >=200 msec	0 Participants
(Stage 2) Placebo	Number of Participants With ECG Abnormalities (Amended Stage 2)	QTcF Chg (msec) >=60	0 Participants
(Stage 2) Placebo	Number of Participants With ECG Abnormalities (Amended Stage 2)	QTcF Interval Aggregate 450<=Value<480 msec	3 Participants
(Stage 2) Placebo	Number of Participants With ECG Abnormalities (Amended Stage 2)	PR Interval Aggregate Value >=300 msec	0 Participants
(Stage 2) Placebo	Number of Participants With ECG Abnormalities (Amended Stage 2)	30<=QTcF Chg (msec)<60	1 Participants
(Stage 2) Placebo	Number of Participants With ECG Abnormalities (Amended Stage 2)	QTcF Interval Aggregate 480<=Value<500 msec	0 Participants
(Stage 2) PF-06823859 150 mg IV	Number of Participants With ECG Abnormalities (Amended Stage 2)	QTcF Chg (msec) >=60	0 Participants
(Stage 2) PF-06823859 150 mg IV	Number of Participants With ECG Abnormalities (Amended Stage 2)	PR Interval Aggregate Value >=300 msec	0 Participants
(Stage 2) PF-06823859 150 mg IV	Number of Participants With ECG Abnormalities (Amended Stage 2)	QRS Duration Aggregate Value >=200 msec	0 Participants
(Stage 2) PF-06823859 150 mg IV	Number of Participants With ECG Abnormalities (Amended Stage 2)	QT Interval Aggregate Value >=500 msec	0 Participants
(Stage 2) PF-06823859 150 mg IV	Number of Participants With ECG Abnormalities (Amended Stage 2)	QTcF Interval Aggregate 450<=Value<480 msec	0 Participants
(Stage 2) PF-06823859 150 mg IV	Number of Participants With ECG Abnormalities (Amended Stage 2)	QTcF Interval Aggregate 480<=Value<500 msec	0 Participants
(Stage 2) PF-06823859 150 mg IV	Number of Participants With ECG Abnormalities (Amended Stage 2)	QTcF Interval Aggregate Value >=500 msec	0 Participants
(Stage 2) PF-06823859 150 mg IV	Number of Participants With ECG Abnormalities (Amended Stage 2)	PR %Chg >=25% or >=50%	0 Participants
(Stage 2) PF-06823859 150 mg IV	Number of Participants With ECG Abnormalities (Amended Stage 2)	QRS Duration %Chg >=25% or >=50%	0 Participants
(Stage 2) PF-06823859 150 mg IV	Number of Participants With ECG Abnormalities (Amended Stage 2)	30<=QTcF Chg (msec)<60	0 Participants

Secondary

Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)

Time frame: Up to Week 28

Population: The SAS1 and SAS2 included all participants who received at least 1 dose of randomized treatment in Stage 1 and Stage 2, respectively.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
(Stage 1) Placebo	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	QT Interval Aggregate Value >=500 msec	0 Participants
(Stage 1) Placebo	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	QTcF Chg (msec) >=60	0 Participants
(Stage 1) Placebo	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	QTcF Interval Aggregate 450<=Value<480 msec	3 Participants
(Stage 1) Placebo	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	30<=QTcF Chg (msec)<60	0 Participants
(Stage 1) Placebo	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	QRS Duration %Chg >=25% or >=50%	0 Participants
(Stage 1) Placebo	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	QRS Duration Aggregate Value >=200 msec	0 Participants
(Stage 1) Placebo	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	PR Interval Aggregate Value >=300 msec	0 Participants
(Stage 1) Placebo	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	PR %Chg >=25% or >=50%	0 Participants
(Stage 1) Placebo	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	QTcF Interval Aggregate Value >=500 msec	0 Participants
(Stage 1) Placebo	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	QTcF Interval Aggregate 480<=Value<500 msec	0 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	QRS Duration Aggregate Value >=200 msec	0 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	PR Interval Aggregate Value >=300 msec	0 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	QT Interval Aggregate Value >=500 msec	0 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	QTcF Interval Aggregate 450<=Value<480 msec	1 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	QTcF Interval Aggregate 480<=Value<500 msec	0 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	QTcF Interval Aggregate Value >=500 msec	1 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	PR %Chg >=25% or >=50%	0 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	QRS Duration %Chg >=25% or >=50%	0 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	30<=QTcF Chg (msec)<60	0 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	QTcF Chg (msec) >=60	1 Participants
(Stage 2) Placebo	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	QTcF Interval Aggregate Value >=500 msec	0 Participants
(Stage 2) Placebo	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	30<=QTcF Chg (msec)<60	0 Participants
(Stage 2) Placebo	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	QT Interval Aggregate Value >=500 msec	0 Participants
(Stage 2) Placebo	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	QTcF Interval Aggregate 450<=Value<480 msec	0 Participants
(Stage 2) Placebo	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	QRS Duration Aggregate Value >=200 msec	0 Participants
(Stage 2) Placebo	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	QTcF Interval Aggregate 480<=Value<500 msec	0 Participants
(Stage 2) Placebo	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	PR %Chg >=25% or >=50%	0 Participants
(Stage 2) Placebo	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	PR Interval Aggregate Value >=300 msec	0 Participants
(Stage 2) Placebo	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	QTcF Chg (msec) >=60	0 Participants
(Stage 2) Placebo	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	QRS Duration %Chg >=25% or >=50%	0 Participants
(Stage 2) PF-06823859 150 mg IV	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	QRS Duration Aggregate Value >=200 msec	0 Participants
(Stage 2) PF-06823859 150 mg IV	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	QTcF Chg (msec) >=60	0 Participants
(Stage 2) PF-06823859 150 mg IV	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	PR Interval Aggregate Value >=300 msec	0 Participants
(Stage 2) PF-06823859 150 mg IV	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	QT Interval Aggregate Value >=500 msec	0 Participants
(Stage 2) PF-06823859 150 mg IV	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	QTcF Interval Aggregate Value >=500 msec	0 Participants
(Stage 2) PF-06823859 150 mg IV	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	QRS Duration %Chg >=25% or >=50%	0 Participants
(Stage 2) PF-06823859 150 mg IV	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	30<=QTcF Chg (msec)<60	0 Participants
(Stage 2) PF-06823859 150 mg IV	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	PR %Chg >=25% or >=50%	0 Participants
(Stage 2) PF-06823859 150 mg IV	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	QTcF Interval Aggregate 450<=Value<480 msec	1 Participants
(Stage 2) PF-06823859 150 mg IV	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	QTcF Interval Aggregate 480<=Value<500 msec	0 Participants
(Stage 2) PF-06823859 600 mg IV	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	QTcF Interval Aggregate 450<=Value<480 msec	0 Participants
(Stage 2) PF-06823859 600 mg IV	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	30<=QTcF Chg (msec)<60	0 Participants
(Stage 2) PF-06823859 600 mg IV	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	QTcF Interval Aggregate 480<=Value<500 msec	0 Participants
(Stage 2) PF-06823859 600 mg IV	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	QTcF Interval Aggregate Value >=500 msec	0 Participants
(Stage 2) PF-06823859 600 mg IV	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	QTcF Chg (msec) >=60	0 Participants
(Stage 2) PF-06823859 600 mg IV	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	PR %Chg >=25% or >=50%	0 Participants
(Stage 2) PF-06823859 600 mg IV	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	PR Interval Aggregate Value >=300 msec	0 Participants
(Stage 2) PF-06823859 600 mg IV	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	QRS Duration %Chg >=25% or >=50%	0 Participants
(Stage 2) PF-06823859 600 mg IV	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	QT Interval Aggregate Value >=500 msec	0 Participants
(Stage 2) PF-06823859 600 mg IV	Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)	QRS Duration Aggregate Value >=200 msec	0 Participants

Secondary

Number of Participants With TEAEs and SAEs (Amended Stage 2)

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.

Time frame: Up to Week 40

Population: 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.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
(Stage 1) Placebo	Number of Participants With TEAEs and SAEs (Amended Stage 2)	TEAEs	1 Participants
(Stage 1) Placebo	Number of Participants With TEAEs and SAEs (Amended Stage 2)	SAEs	0 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With TEAEs and SAEs (Amended Stage 2)	SAEs	0 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With TEAEs and SAEs (Amended Stage 2)	TEAEs	1 Participants
(Stage 2) Placebo	Number of Participants With TEAEs and SAEs (Amended Stage 2)	TEAEs	8 Participants
(Stage 2) Placebo	Number of Participants With TEAEs and SAEs (Amended Stage 2)	SAEs	0 Participants
(Stage 2) PF-06823859 150 mg IV	Number of Participants With TEAEs and SAEs (Amended Stage 2)	TEAEs	3 Participants
(Stage 2) PF-06823859 150 mg IV	Number of Participants With TEAEs and SAEs (Amended Stage 2)	SAEs	0 Participants

Secondary

Number of Participants With TEAEs and SAEs (Stage 1 and Stage 2)

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.

Time frame: Up to Week 28

Population: 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.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
(Stage 1) Placebo	Number of Participants With TEAEs and SAEs (Stage 1 and Stage 2)	TEAEs	8 Participants
(Stage 1) Placebo	Number of Participants With TEAEs and SAEs (Stage 1 and Stage 2)	SAEs	1 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With TEAEs and SAEs (Stage 1 and Stage 2)	TEAEs	20 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With TEAEs and SAEs (Stage 1 and Stage 2)	SAEs	2 Participants
(Stage 2) Placebo	Number of Participants With TEAEs and SAEs (Stage 1 and Stage 2)	TEAEs	1 Participants
(Stage 2) Placebo	Number of Participants With TEAEs and SAEs (Stage 1 and Stage 2)	SAEs	0 Participants
(Stage 2) PF-06823859 150 mg IV	Number of Participants With TEAEs and SAEs (Stage 1 and Stage 2)	SAEs	0 Participants
(Stage 2) PF-06823859 150 mg IV	Number of Participants With TEAEs and SAEs (Stage 1 and Stage 2)	TEAEs	5 Participants
(Stage 2) PF-06823859 600 mg IV	Number of Participants With TEAEs and SAEs (Stage 1 and Stage 2)	TEAEs	3 Participants
(Stage 2) PF-06823859 600 mg IV	Number of Participants With TEAEs and SAEs (Stage 1 and Stage 2)	SAEs	0 Participants

Secondary

Number of Participants With Vital Sign Abnormalities (Amended Stage 2)

Abnormality in vital signs: Sitting pulse rate \<40 bpm to \>120 bpm, sitting DBP \< 50 mmHg, sitting SBP \<90 mmHg.

Time frame: Up to Week 40

Population: The SASA2 includes all participants who received at least one dose of randomized treatment in Amended Stage 2.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
(Stage 1) Placebo	Number of Participants With Vital Sign Abnormalities (Amended Stage 2)	Sitting Pulse Rate Value <40 bpm	0 Participants
(Stage 1) Placebo	Number of Participants With Vital Sign Abnormalities (Amended Stage 2)	Sitting SBP Value <90 mmHg	0 Participants
(Stage 1) Placebo	Number of Participants With Vital Sign Abnormalities (Amended Stage 2)	Sitting Pulse Rate Value >120 bpm	0 Participants
(Stage 1) Placebo	Number of Participants With Vital Sign Abnormalities (Amended Stage 2)	Sitting DBP Value <50 mmHg	0 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With Vital Sign Abnormalities (Amended Stage 2)	Sitting SBP Value <90 mmHg	0 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With Vital Sign Abnormalities (Amended Stage 2)	Sitting Pulse Rate Value <40 bpm	0 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With Vital Sign Abnormalities (Amended Stage 2)	Sitting DBP Value <50 mmHg	0 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With Vital Sign Abnormalities (Amended Stage 2)	Sitting Pulse Rate Value >120 bpm	0 Participants
(Stage 2) Placebo	Number of Participants With Vital Sign Abnormalities (Amended Stage 2)	Sitting Pulse Rate Value <40 bpm	0 Participants
(Stage 2) Placebo	Number of Participants With Vital Sign Abnormalities (Amended Stage 2)	Sitting SBP Value <90 mmHg	0 Participants
(Stage 2) Placebo	Number of Participants With Vital Sign Abnormalities (Amended Stage 2)	Sitting DBP Value <50 mmHg	0 Participants
(Stage 2) Placebo	Number of Participants With Vital Sign Abnormalities (Amended Stage 2)	Sitting Pulse Rate Value >120 bpm	0 Participants
(Stage 2) PF-06823859 150 mg IV	Number of Participants With Vital Sign Abnormalities (Amended Stage 2)	Sitting SBP Value <90 mmHg	0 Participants
(Stage 2) PF-06823859 150 mg IV	Number of Participants With Vital Sign Abnormalities (Amended Stage 2)	Sitting DBP Value <50 mmHg	0 Participants
(Stage 2) PF-06823859 150 mg IV	Number of Participants With Vital Sign Abnormalities (Amended Stage 2)	Sitting Pulse Rate Value >120 bpm	0 Participants
(Stage 2) PF-06823859 150 mg IV	Number of Participants With Vital Sign Abnormalities (Amended Stage 2)	Sitting Pulse Rate Value <40 bpm	0 Participants

Secondary

Number of Participants With Vital Sign Abnormalities (Stage 1 and Stage 2)

Abnormality in vital signs: Sitting pulse rate \<40 bpm to \>120 bpm, sitting DBP \< 50 mmHg, sitting SBP \<90 mmHg.

Time frame: Up to Week 28

Population: The SAS1 and SAS2 included all participants who received at least 1 dose of randomized treatment in Stage 1 and Stage 2, respectively.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
(Stage 1) Placebo	Number of Participants With Vital Sign Abnormalities (Stage 1 and Stage 2)	Sitting SBP Value <90 mmHg	0 Participants
(Stage 1) Placebo	Number of Participants With Vital Sign Abnormalities (Stage 1 and Stage 2)	Sitting DBP Value <50 mmHg	0 Participants
(Stage 1) Placebo	Number of Participants With Vital Sign Abnormalities (Stage 1 and Stage 2)	Sitting Pulse Rate Value <40 bpm	0 Participants
(Stage 1) Placebo	Number of Participants With Vital Sign Abnormalities (Stage 1 and Stage 2)	Sitting Pulse Rate Value >120 bpm	0 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With Vital Sign Abnormalities (Stage 1 and Stage 2)	Sitting SBP Value <90 mmHg	1 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With Vital Sign Abnormalities (Stage 1 and Stage 2)	Sitting Pulse Rate Value >120 bpm	0 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With Vital Sign Abnormalities (Stage 1 and Stage 2)	Sitting DBP Value <50 mmHg	0 Participants
PF-06823859 600 mg IV (Stage 1)	Number of Participants With Vital Sign Abnormalities (Stage 1 and Stage 2)	Sitting Pulse Rate Value <40 bpm	0 Participants
(Stage 2) Placebo	Number of Participants With Vital Sign Abnormalities (Stage 1 and Stage 2)	Sitting Pulse Rate Value >120 bpm	0 Participants
(Stage 2) Placebo	Number of Participants With Vital Sign Abnormalities (Stage 1 and Stage 2)	Sitting DBP Value <50 mmHg	0 Participants
(Stage 2) Placebo	Number of Participants With Vital Sign Abnormalities (Stage 1 and Stage 2)	Sitting Pulse Rate Value <40 bpm	0 Participants
(Stage 2) Placebo	Number of Participants With Vital Sign Abnormalities (Stage 1 and Stage 2)	Sitting SBP Value <90 mmHg	0 Participants
(Stage 2) PF-06823859 150 mg IV	Number of Participants With Vital Sign Abnormalities (Stage 1 and Stage 2)	Sitting SBP Value <90 mmHg	0 Participants
(Stage 2) PF-06823859 150 mg IV	Number of Participants With Vital Sign Abnormalities (Stage 1 and Stage 2)	Sitting DBP Value <50 mmHg	0 Participants
(Stage 2) PF-06823859 150 mg IV	Number of Participants With Vital Sign Abnormalities (Stage 1 and Stage 2)	Sitting Pulse Rate Value >120 bpm	0 Participants
(Stage 2) PF-06823859 150 mg IV	Number of Participants With Vital Sign Abnormalities (Stage 1 and Stage 2)	Sitting Pulse Rate Value <40 bpm	0 Participants
(Stage 2) PF-06823859 600 mg IV	Number of Participants With Vital Sign Abnormalities (Stage 1 and Stage 2)	Sitting Pulse Rate Value >120 bpm	0 Participants
(Stage 2) PF-06823859 600 mg IV	Number of Participants With Vital Sign Abnormalities (Stage 1 and Stage 2)	Sitting Pulse Rate Value <40 bpm	0 Participants
(Stage 2) PF-06823859 600 mg IV	Number of Participants With Vital Sign Abnormalities (Stage 1 and Stage 2)	Sitting DBP Value <50 mmHg	0 Participants
(Stage 2) PF-06823859 600 mg IV	Number of Participants With Vital Sign Abnormalities (Stage 1 and Stage 2)	Sitting SBP Value <90 mmHg	0 Participants

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026

A Study In Adults With Moderate To Severe Dermatomyositis

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

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)

Number of Participants With Clinically Significant Laboratory Abnormalities (Stage 3)

Number of Participants With Electrocardiogram (ECG) Abnormalities (Stage 3)

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE) (Stage 3)

Number of Participants With Vital Sign Abnormalities (Stage 3)

Absolute Values for Total Improvement Score (TIS) at Week 12 and Intermediate Scheduled Time Points (Stage 3)

Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)

Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)

Change From Baseline in CDASI Activity Score at All Scheduled Timepoints Through Week 12 (Stage 3)

Change From Baseline in CDASI Activity Score at at All Scheduled Timepoints Through Week 12 (Stage 1, Stage 2 and Amended Stage 2)

Change From Baseline in the Core Set Measures (CSM) of the TIS (Global Disease Activity [PhGA] and Extramuscular Global Assessment [EmGA]) (Stage 3)

Change From Baseline in the CSM of the TIS (Aldolase and Creatine Kinase) (Stage 3)

Change From Baseline in the CSM of the TIS (MMT8 and HAQ01-HAQ-DI) (Stage 3)

Change From Baseline in the CSM of the TIS (PtGA) (Stage 3)

Number of Participants With Clinically Significant Laboratory Abnormalities (Amended Stage 2)

Number of Participants With Clinically Significant Laboratory Abnormalities (Stage 1 and Stage 2)

Number of Participants With ECG Abnormalities (Amended Stage 2)

Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)

Number of Participants With TEAEs and SAEs (Amended Stage 2)

Number of Participants With TEAEs and SAEs (Stage 1 and Stage 2)

Number of Participants With Vital Sign Abnormalities (Amended Stage 2)

Number of Participants With Vital Sign Abnormalities (Stage 1 and Stage 2)