To Assess the Effect of SCD-044 Treatment on Moderate to... | NCT04566666

Label	Type	Description	Intervention Names
Placebo of SCD-044 product	Placebo Comparator	Placebo of SCD-044 study drug	Drug: Placebo
SCD-044 Tablets_Low Dose (Dose 1)	Active Comparator	SCD-044 tablets at Low Dose (Dose 1)	Drug: SCD-044_Low Dose (Dose 1)
SCD-044 Tablets_Intermediate Dose (Dose 2)	Active Comparator	SCD-044 tablets at Intermediate Dose (Dose 2)	Drug: SCD-044_Intermediate Dose (Dose 2)
SCD-044 Tablets_High Dose (Dose 3)	Active Comparator	SCD-044 tablets at High Dose (Dose 3)	Drug: SCD-044_High Dose (Dose 3)

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Placebo of SCD-044 product	Placebo of SCD-044 product

Measure	Description	Time Frame
Proportion of Subjects With at Least 75% Improvement in PASI (PASI 75)	The subjects showing at least 75% improvement in Psoriasis Area and Severity Index score on a scale of 0-4 score. Higher score denotes more severe disease activity. The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.	Week16

Measure	Description	Time Frame
Investigator's Global Assessment (IGA) Score	The subjects achieving predefined improvement (0 or 1) in Investigator's Global Assessment (IGA) of disease severity on a scale of 0 to 4 score with at least two-grade reduction from Baseline to Week 16. 0 indicates clear, while 1 indicates almost clear, while 4 is severe. The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.

Facility	Status	City	State	ZIP	Country	Contacts
Yuma Clinical Trials, LLC		Yuma	Arizona	85364	United States
T. Joseph Raoof Md, Imc./Encino Research Center

ID	Title	Description
FG000	Part 1- Placebo of SCD-044 Product	Placebo of SCD-044 study drug Placebo: Placebo of SCD-044 product
FG001	Part 1- SCD-044 Tablets_Low Dose (Dose 1)	SCD-044 tablets at Low Dose (Dose 1) SCD-044_Dose 1: SCD-044 tablets in Low Dose (Dose 1)

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 22, 2023	Nov 18, 2025

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Proportion of Subjects With at Least 75% Improvement in PASI (PASI 75)

The subjects showing at least 75% improvement in Psoriasis Area and Severity Index score on a scale of 0-4 score. Higher score denotes more severe disease activity.

The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.

Posted

Number

percentage of subjects

Week16

ID	Title	Description
OG000	Placebo of SCD-044 Product	Placebo: Placebo of SCD-044 product
OG001	SCD-044 Tablets_Dose 1	SCD-044_Dose 1: SCD-044 tablets in Dose 1.
OG002	SCD-044 Tablets_Dose 2	SCD-044_Dose 2: SCD-044 tablets in Dose 2
OG003	SCD-044 Tablets_Dose 3	SCD-044_Dose 3: SCD-044 in Dose 3

Units	Counts
Participants	OG00050 OG00160 OG00261 OG003

Title

Denominators

Categories

Title	Measurements
	OG00014.0 OG00128.3 OG00223.0 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Cochran-Mantel-Haenszel		0.1011														Superiority
OG000 OG002		Cochran-Mantel-Haenszel		0.2666

Secondary

Investigator's Global Assessment (IGA) Score

The subjects achieving predefined improvement (0 or 1) in Investigator's Global Assessment (IGA) of disease severity on a scale of 0 to 4 score with at least two-grade reduction from Baseline to Week 16. 0 indicates clear, while 1 indicates almost clear, while 4 is severe.

The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.

Posted

Number

percentage of subject

Week 16

ID	Title	Description
OG000	Placebo of SCD-044 Product	Placebo: Placebo of SCD-044 product
OG001	SCD-044 Tablets_Dose 1	SCD-044_Dose 1: SCD-044 tablets in Dose 1.
OG002	SCD-044 Tablets_Dose 2	SCD-044_Dose 2: SCD-044 tablets in Dose 2
OG003	SCD-044 Tablets_Dose 3	SCD-044_Dose 3: SCD-044 in Dose 3

Secondary

Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores

The subjects achieving predefined improvement in Psoriasis Area and Severity Index (PASI) on a scale of 0-4 score. Higher score denotes more severe disease activity..

Posted

Mean

Standard Deviation

score on a scale

Week 52

ID	Title	Description
OG000	Part I Responders: Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)	Part I (16 weeks)- Placebo Part II (Week 16 to Week 28:)- Part I responders will be re-randomized to SCD-044 tablets of intermediate dose (Dose 2) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
OG001	Part I Responders: Placebo to SCD-044 Tablets of High Dose (Dose 3)	Part 1- Placebo Part 2- Part I responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
OG002	Part I Responders: SCD-044 Low Dose (Dose 1) to Low Dose (Dose 1)	Part 1- SCD-044 tablets of low dose (Dose 2) Part 2- Part I responders will remain on SCD-044 tablets of low dose (Dose 1) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.

Secondary

Psoriasis Area and Severity Index (PASI) Response Rate

Psoriasis Area and Severity Index (PASI50, PASI75, PASI90, and PASI100) response rate at Week 16.

PASI50, PASI75, PASI90 and PASI100 are defined as 50%, 75%, 90% and 100% decrease from baseline in PASI correspondingly.

The data represents the percentage of subject who achieved PASI 50, PASI 75, PASI 90, and PASI 100 at week 16.

Posted

Number

Percentage of subject

Week 16

ID	Title	Description
OG000	Placebo of SCD-044 Product	Placebo tablet of SCD-044 product
OG001	SCD-044 Tablets_Dose 1	SCD-044 Tablets of low dose (Dose 1)
OG002	SCD-044 Tablets_Dose 2	SCD-044 Tablets of intermediate dose (Dose 2)
OG003	SCD-044 Tablets_Dose 3	SCD-044 Tablets of high dose (Dose 3)

Units

Secondary

Psoriasis Area and Severity Index (PASI) Response Rate

Psoriasis Area and Severity Index (PASI50, PASI75, PASI90, and PASI100) response rate at Week 52 The data represents the percentage of subject who achieved PASI 50, PASI 75, PASI 90, and PASI 100 at week 16.

Posted

Number

percentage of subjects

Week 52

ID	Title	Description
OG000	Part I Responders: Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)	Part I (16 weeks)- Placebo Part II (Week 16 to Week 28:)- Part I responders will be re-randomized to SCD-044 tablets of intermediate dose (Dose 2) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
OG001	Part I Responders: Placebo to SCD-044 Tablets of High Dose (Dose 3)	Part 1- Placebo Part 2- Part I responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
OG002	Part I Responders: SCD-044 Low Dose (Dose 1) to Low Dose (Dose 1)	Part 1- SCD-044 tablets of low dose (Dose 2) Part 2- Part I responders will remain on SCD-044 tablets of low dose (Dose 1) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.

Secondary

Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) at Week 16

At study week 0, 16, and 52; based on 11-item questionnaire, the symptoms and patient-observable signs in psoriasis will be scored using 0 to 10 rating scale (0-absent, 10-worst imaginable). The summary score is the sum of item scores (0-110), and a higher score indicates more severe disease- 0- best outcome 110- worst outcome

Posted

Mean

Standard Deviation

score on a scale

Week 16

ID	Title	Description
OG000	Placebo of SCD-044 Product	Placebo tablet of SCD-044 product
OG001	SCD-044 Tablets_Dose 1	SCD-044 Tablets of low dose (Dose 1)
OG002	SCD-044 Tablets_Dose 2	SCD-044 Tablets of intermediate dose (Dose 2)
OG003	SCD-044 Tablets_Dose 3	SCD-044 Tablets of high dose (Dose 3)

Secondary

Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) at Week 52

Posted

Mean

Standard Deviation

score on a scale

Week 52

ID	Title	Description
OG000	Part I Responders: Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)	Part I (16 weeks)- Placebo Part II (Week 16 to Week 28:)- Part I responders will be re-randomized to SCD-044 tablets of intermediate dose (Dose 2) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
OG001	Part I Responders: Placebo to SCD-044 Tablets of High Dose (Dose 3)	Part 1- Placebo Part 2- Part I responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
OG002	Part I Responders: SCD-044 Low Dose (Dose 1) to Low Dose (Dose 1)

Secondary

Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16

At study week 0, 16, and 52; based on 10-item questionnaire on skin problems (0 to 3 scale).

The scoring of each question is as follows: Very Much or Yes = 3, A lot = 2, A little = 2, Not relevant or Not at all or No = 0.

The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.

Total score range: 0-30 (higher = greater impact).

Interpretation bands:

0-1: No effect 2-5: Small effect 6-10: Moderate effect 11-20: Very large effect 21-30: Extremely large effect.

Posted

Mean

Standard Deviation

score on a scale

Week 16

ID	Title	Description
OG000	Placebo of SCD-044 Product	Placebo tablet of SCD-044 product
OG001	SCD-044 Tablets_Dose 1	SCD-044 Tablets of low dose (Dose 1)
OG002	SCD-044 Tablets_Dose 2	SCD-044 Tablets of intermediate dose (Dose 2)
OG003	SCD-044 Tablets_Dose 3	SCD-044 Tablets of high dose (Dose 3)

Secondary

Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 52

At study week 0, 16, and 52; based on 10-item questionnaire on skin problems (0 to 3 scale).

The scoring of each question is as follows: Very Much or Yes = 3, A lot = 2, A little = 2, Not relevant or Not at all or No = 0.

The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.

Total score range: 0-30 (higher = greater impact).

Interpretation bands:

0-1: No effect 2-5: Small effect 6-10: Moderate effect 11-20: Very large effect 21-30: Extremely large effect.

Posted

Mean

Standard Deviation

score on a scale

Week 52

ID	Title	Description
OG000	Part I Responders: Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)	Part I (16 weeks)- Placebo Part II (Week 16 to Week 28:)- Part I responders will be re-randomized to SCD-044 tablets of intermediate dose (Dose 2) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
OG001	Part I Responders: Placebo to SCD-044 Tablets of High Dose (Dose 3)	Part 1- Placebo Part 2- Part I responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.

Secondary

Investigator's Global Assessment (IGA) Score

The subjects achieving predefined improvement (0 or 1) in Investigator's Global Assessment (IGA) of disease severity on a scale of 0 to 4 score with at least two-grade reduction from Baseline to Week 52. 0 indicates clear, while 1 indicates almost clear, while 4 is severe.

The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.

Posted

Number

Percentage of participants

Week 52

ID	Title	Description
OG000	Part I Responders: Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)	Part I (16 weeks)- Placebo Part II (Week 16 to Week 28:)- Part I responders will be re-randomized to SCD-044 tablets of intermediate dose (Dose 2) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
OG001	Part I Responders: Placebo to SCD-044 Tablets of High Dose (Dose 3)	Part 1- Placebo Part 2- Part I responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
OG002	Part I Responders: SCD-044 Low Dose (Dose 1) to Low Dose (Dose 1)

Secondary

Change From Baseline in Body Surface Area (BSA) at Week 16

At study weeks 16, and 52, the Investigator will assess % BSA affected with psoriasis.

Posted

Mean

Standard Deviation

% BSA

Week 16

ID	Title	Description
OG000	Placebo of SCD-044 Product	Placebo tablet of SCD-044 product
OG001	SCD-044 Tablets_Dose 1	SCD-044 Tablets of low dose (Dose 1)
OG002	SCD-044 Tablets_Dose 2	SCD-044 Tablets of intermediate dose (Dose 2)
OG003	SCD-044 Tablets_Dose 3	SCD-044 Tablets of high dose (Dose 3)

Units	Counts
Participants

Secondary

Change From Baseline in Body Surface Area (BSA) at Week 52

At study weeks 16, and 52, the Investigator will assess % BSA affected with psoriasis.

Posted

Mean

Standard Deviation

% BSA

Week 52

ID	Title	Description
OG000	Part I Responders: Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)	Part I (16 weeks)- Placebo Part II (Week 16 to Week 28:)- Part I responders will be re-randomized to SCD-044 tablets of intermediate dose (Dose 2) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
OG001	Part I Responders: Placebo to SCD-044 Tablets of High Dose (Dose 3)	Part 1- Placebo Part 2- Part I responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
OG002	Part I Responders: SCD-044 Low Dose (Dose 1) to Low Dose (Dose 1)	Part 1- SCD-044 tablets of low dose (Dose 2) Part 2- Part I responders will remain on SCD-044 tablets of low dose (Dose 1) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.

Secondary

Patient Global Impression of Severity (PGIS)

Subjects will be asked to assess their overall impression of disease severity using a scale of None, Mild, Moderate or Severe (None- best outcome no symptoms; Severe- worst symptoms)

Posted

Count of Participants

Participants

Baseline

ID	Title	Description
OG000	Placebo of SCD-044 Product	Placebo tablet of SCD-044 product
OG001	SCD-044 Tablets_Dose 1	SCD-044 Tablets of low dose (Dose 1)
OG002	SCD-044 Tablets_Dose 2	SCD-044 Tablets of intermediate dose (Dose 2)
OG003	SCD-044 Tablets_Dose 3	SCD-044 Tablets of high dose (Dose 3)

Units	Counts
Participants

Secondary

Patient Global Impression of Severity (PGIS)

At study weeks 0, 16, and 52, subjects will be asked to assess their overall impression of disease severity using a scale of None, Mild, Moderate or Severe.

Posted

Count of Participants

Participants

Week 16

ID	Title	Description
OG000	Placebo of SCD-044 Product	Placebo tablet of SCD-044 product
OG001	SCD-044 Tablets_Dose 1	SCD-044 Tablets of low dose (Dose 1)
OG002	SCD-044 Tablets_Dose 2	SCD-044 Tablets of intermediate dose (Dose 2)
OG003	SCD-044 Tablets_Dose 3	SCD-044 Tablets of high dose (Dose 3)

Units	Counts
Participants

Secondary

Patient Global Impression of Severity (PGIS)

Subjects will be asked to assess their overall impression of disease severity using a scale of None, Mild, Moderate or Severe.

Posted

Count of Participants

Participants

Week 52

ID	Title	Description
OG000	Part I Responders: Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)	Part I (16 weeks)- Placebo Part II (Week 16 to Week 28:)- Part I responders will be re-randomized to SCD-044 tablets of intermediate dose (Dose 2) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
OG001	Part I Responders: Placebo to SCD-044 Tablets of High Dose (Dose 3)	Part 1- Placebo Part 2- Part I responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
OG002	Part I Responders: SCD-044 Low Dose (Dose 1) to Low Dose (Dose 1)	Part 1- SCD-044 tablets of low dose (Dose 2) Part 2- Part I responders will remain on SCD-044 tablets of low dose (Dose 1) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.

Secondary

Patient Global Impression of Change (PGIC)

Subjects will be asked to assess if there has been a change in clinical status using a 5 point scale (1 to 5). 1 indicating 'Much better', while 5 indicating 'Much Worse'.

Posted

Number

participants

Week 52

ID	Title	Description
OG000	Part I Responders: Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)	Part I (16 weeks)- Placebo Part II (Week 16 to Week 28:)- Part I responders will be re-randomized to SCD-044 tablets of intermediate dose (Dose 2) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
OG001	Part I Responders: Placebo to SCD-044 Tablets of High Dose (Dose 3)	Part 1- Placebo Part 2- Part I responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
OG002	Part I Responders: SCD-044 Low Dose (Dose 1) to Low Dose (Dose 1)	Part 1- SCD-044 tablets of low dose (Dose 2) Part 2- Part I responders will remain on SCD-044 tablets of low dose (Dose 1) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.

Secondary

Evaluate Pharmacokinetic Parameter

Steady-state maximum plasma concentration (Cmax-ss)

Posted

Mean

Standard Deviation

pg/mL

Week 52

ID	Title	Description
OG000	Part I Responders: Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)	Part I (16 weeks)- Placebo Part II (Week 16 to Week 28:)- Part I responders will be re-randomized to SCD-044 tablets of intermediate dose (Dose 2) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
OG001	Part I Responders: Placebo to SCD-044 Tablets of High Dose (Dose 3)	Part 1- Placebo Part 2- Part I responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
OG002	Part I Responders: SCD-044 Low Dose (Dose 1) to Low Dose (Dose 1)	Part 1- SCD-044 tablets of low dose (Dose 2) Part 2- Part I responders will remain on SCD-044 tablets of low dose (Dose 1) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.

Secondary

Subjects With Adverse Events

Total Number Affected by adverse events from Baseline through Week 56

Posted

Count of Participants

Participants

Week 56

ID	Title	Description
OG000	Part 1- Placebo of SCD-044 Product	Placebo tablet of SCD-044 product
OG001	Part 1- SCD-044 Tablets_Dose 1	SCD-044 Tablets of low dose (Dose 1)
OG002	Part 1- SCD-044 Tablets_Dose 2	SCD-044 Tablets of intermediate dose (Dose 2)
OG003	Part 1- SCD-044 Tablets_Dose 3	SCD-044 Tablets of high dose (Dose 3)
OG004	Placebo to SCD-044 Intermediate Dose (Dose 2)	Subjects initially randomized to Placebo re-randomized to SCD-044 tablets of intermediate dose in Part II

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG0030 affected59 at risk EG0040 affected18 at risk EG0050 affected22 at risk EG0060 affected32 at risk EG0070 affected36 at risk EG0080 affected20 at risk EG0090 affected20 at risk EG0100 affected16 at risk
Thrombocytosis	Blood and lymphatic system disorders	Systematic Assessment	EG0001 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Atrial fibrillation	Cardiac disorders	Systematic Assessment	EG0001 affected64 at risk EG0010 affected71 at risk EG0021 affected69 at risk EG003
Atrioventricular block first degree	Cardiac disorders	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Atrioventricular block second degree	Cardiac disorders	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Sinoatrial block	Cardiac disorders	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Sinus tachycardia	Cardiac disorders	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Tachycardia	Cardiac disorders	Systematic Assessment	EG0001 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Type V hyperlipidaemia	Congenital, familial and genetic disorders	Systematic Assessment	EG0000 affected64 at risk EG0011 affected71 at risk EG0020 affected69 at risk EG003
Dry age-related macular degeneration	Eye disorders	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0021 affected69 at risk EG003
Dry eye	Eye disorders	Systematic Assessment	EG0000 affected64 at risk EG0011 affected71 at risk EG0020 affected69 at risk EG003
Iridocyclitis	Eye disorders	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0021 affected69 at risk EG003
Macular oedema	Eye disorders	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0021 affected69 at risk EG003
Vision blurred	Eye disorders	Systematic Assessment	EG0001 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Myopia	Eye disorders	Systematic Assessment	EG0001 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0000 affected64 at risk EG0012 affected71 at risk EG0023 affected69 at risk EG003
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0000 affected64 at risk EG0012 affected71 at risk EG0020 affected69 at risk EG003
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0023 affected69 at risk EG003
Toothache	Gastrointestinal disorders	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0022 affected69 at risk EG003
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Colitis	Gastrointestinal disorders	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0021 affected69 at risk EG003
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0001 affected64 at risk EG0010 affected71 at risk EG0021 affected69 at risk EG003
Dental caries	Gastrointestinal disorders	Systematic Assessment	EG0000 affected64 at risk EG0011 affected71 at risk EG0020 affected69 at risk EG003
Dyspepsia	Gastrointestinal disorders	Systematic Assessment	EG0000 affected64 at risk EG0011 affected71 at risk EG0020 affected69 at risk EG003
Frequent bowel movements	Gastrointestinal disorders	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0021 affected69 at risk EG003
Gingival swelling	Gastrointestinal disorders	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Rectal tenesmus	Gastrointestinal disorders	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0021 affected69 at risk EG003
Fatigue	General disorders	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0022 affected69 at risk EG003
Pyrexia	General disorders	Systematic Assessment	EG0000 affected64 at risk EG0011 affected71 at risk EG0022 affected69 at risk EG003
Chest discomfort	General disorders	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Non-cardiac chest pain	General disorders	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0021 affected69 at risk EG003
Nasopharyngitis	Infections and infestations	Systematic Assessment	EG0003 affected64 at risk EG0016 affected71 at risk EG0022 affected69 at risk EG003
Upper respiratory tract infection	Infections and infestations	Systematic Assessment	EG0000 affected64 at risk EG0012 affected71 at risk EG0020 affected69 at risk EG003
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0021 affected69 at risk EG003
Abscess	Infections and infestations	Systematic Assessment	EG0000 affected64 at risk EG0011 affected71 at risk EG0020 affected69 at risk EG003
COVID-19	Infections and infestations	Systematic Assessment	EG0002 affected64 at risk EG0010 affected71 at risk EG0021 affected69 at risk EG003
Gastroenteritis viral	Infections and infestations	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0021 affected69 at risk EG003
Helicobacter infection	Infections and infestations	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Herpes simplex	Infections and infestations	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0021 affected69 at risk EG003
Influenza	Infections and infestations	Systematic Assessment	EG0001 affected64 at risk EG0010 affected71 at risk EG0021 affected69 at risk EG003
Penile infection	Infections and infestations	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Pneumonia	Infections and infestations	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0021 affected69 at risk EG003
Respiratory tract infection	Infections and infestations	Systematic Assessment	EG0000 affected64 at risk EG0011 affected71 at risk EG0020 affected69 at risk EG003
Tooth abscess	Infections and infestations	Systematic Assessment	EG0000 affected64 at risk EG0011 affected71 at risk EG0020 affected69 at risk EG003
Viral infection	Infections and infestations	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0021 affected69 at risk EG003
Chest injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0021 affected69 at risk EG003
Fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0021 affected69 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0021 affected69 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0021 affected69 at risk EG003
Alanine aminotransferase increased	Investigations	Systematic Assessment	EG0000 affected64 at risk EG0015 affected71 at risk EG0022 affected69 at risk EG003
Gamma-glutamyltransferase increased	Investigations	Systematic Assessment	EG0001 affected64 at risk EG0012 affected71 at risk EG0021 affected69 at risk EG003
Aspartate aminotransferase increased	Investigations	Systematic Assessment	EG0000 affected64 at risk EG0012 affected71 at risk EG0021 affected69 at risk EG003
Aspartate aminotransferase decreased	Investigations	Systematic Assessment	EG0000 affected64 at risk EG0011 affected71 at risk EG0020 affected69 at risk EG003
Blood bilirubin increased	Investigations	Systematic Assessment	EG0000 affected64 at risk EG0011 affected71 at risk EG0020 affected69 at risk EG003
Electrocardiogram QT prolonged	Investigations	Systematic Assessment	EG0001 affected64 at risk EG0011 affected71 at risk EG0020 affected69 at risk EG003
Heart rate increased	Investigations	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0021 affected69 at risk EG003
Hepatic enzyme abnormal	Investigations	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
International normalised ratio increased	Investigations	Systematic Assessment	EG0000 affected64 at risk EG0011 affected71 at risk EG0020 affected69 at risk EG003
Platelet count increased	Investigations	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Dyslipidaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected64 at risk EG0012 affected71 at risk EG0021 affected69 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected64 at risk EG0010 affected71 at risk EG0021 affected69 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected64 at risk EG0011 affected71 at risk EG0020 affected69 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected64 at risk EG0011 affected71 at risk EG0020 affected69 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Headache	Nervous system disorders	Systematic Assessment	EG0005 affected64 at risk EG0014 affected71 at risk EG0022 affected69 at risk EG003
Dizziness	Nervous system disorders	Systematic Assessment	EG0001 affected64 at risk EG0013 affected71 at risk EG0020 affected69 at risk EG003
Autonomic neuropathy	Nervous system disorders	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Monoparesis	Nervous system disorders	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0021 affected69 at risk EG003
Cerebral artery embolism	Nervous system disorders	Systematic Assessment	EG0001 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Anxiety	Psychiatric disorders	Systematic Assessment	EG0000 affected64 at risk EG0012 affected71 at risk EG0021 affected69 at risk EG003
Affect lability	Psychiatric disorders	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Depressed mood	Psychiatric disorders	Systematic Assessment	EG0000 affected64 at risk EG0011 affected71 at risk EG0020 affected69 at risk EG003
Insomnia	Psychiatric disorders	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Nervousness	Psychiatric disorders	Systematic Assessment	EG0000 affected64 at risk EG0011 affected71 at risk EG0020 affected69 at risk EG003
Poor quality sleep	Psychiatric disorders	Systematic Assessment	EG0000 affected64 at risk EG0011 affected71 at risk EG0020 affected69 at risk EG003
Dysuria	Renal and urinary disorders	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0021 affected69 at risk EG003
Nocturia	Renal and urinary disorders	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Erection increased	Reproductive system and breast disorders	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0021 affected69 at risk EG003
Menstruation delayed	Reproductive system and breast disorders	Systematic Assessment	EG0000 affected64 at risk EG0011 affected71 at risk EG0020 affected69 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected64 at risk EG0011 affected71 at risk EG0024 affected69 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected64 at risk EG0011 affected71 at risk EG0020 affected69 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected64 at risk EG0011 affected71 at risk EG0020 affected0 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected64 at risk EG0011 affected71 at risk EG0020 affected69 at risk EG003
Skin irritation	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 affected64 at risk EG0010 affected71 at risk EG0021 affected69 at risk EG003
Hypertension	Vascular disorders	Systematic Assessment	EG0001 affected64 at risk EG0010 affected71 at risk EG0021 affected69 at risk EG003
Hypertensive crisis	Vascular disorders	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Abdominal distension	Gastrointestinal disorders	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Vertigo	Ear and labyrinth disorders	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Angular cheilitis	Gastrointestinal disorders	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Bronchitis	Infections and infestations	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Cystitis	Infections and infestations	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Diverticulitis	Infections and infestations	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Hordeolum	Infections and infestations	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Lyme disease	Infections and infestations	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Pulpitis dental	Infections and infestations	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Rhinitis	Infections and infestations	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Sinusitis	Infections and infestations	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Animal scratch	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Activated partial thromboplastin time prolonged	Investigations	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Hepatic enzyme increased	Investigations	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Lymphocyte count decreased	Investigations	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Bilirubin conjugated increased	Investigations	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
International normalised ratio abnormal	Investigations	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Liver function test increased	Investigations	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Prothrombin time abnormal	Investigations	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Prothrombin time prolonged	Investigations	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
White blood cell count decreased	Investigations	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Somnolence	Nervous system disorders	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Haematuria	Renal and urinary disorders	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected64 at risk EG0010 affected71 at risk EG0020 affected69 at risk EG003

ID	Title	Description
BG000	Placebo of SCD-044 Product	Placebo: Placebo of SCD-044 product
BG001	SCD-044 Tablets_Dose 1	SCD-044_Dose 1: SCD-044 tablets in Dose 1.
BG002	SCD-044 Tablets_Dose 2	SCD-044_Dose 2: SCD-044 tablets in Dose 2
BG003	SCD-044 Tablets_Dose 3	SCD-044_Dose 3: SCD-044 in Dose 3
BG004	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part 1- Placebo of SCD-044 Product	Placebo tablet of SCD-044 product	64	1	64	17	64
EG001	Part 1- SCD-044 Tablets_Dose 1	SCD-044 Tablets of low dose (Dose 1)	71	0	71	26	71
EG002	Part 1- SCD-044 Tablets_Dose 2	SCD-044 Tablets of intermediate dose (Dose 2)	69	2	69	27	69
EG003	Part 1- SCD-044 Tablets_Dose 3	SCD-044 Tablets of high dose (Dose 3)	59	0	59	18	59
EG004	Placebo to SCD-044 Intermediate Dose (Dose 2)	Subjects initially randomized to Placebo re-randomized to SCD-044 tablets of intermediate dose in Part II	18	0	18	4	18
EG005	Placebo to SCD-044 High Dose (Dose 3)	Subjects initially randomized to Placebo re-randomized to SCD-044 tablets of high dose in Part II	22	0	22	3	22
EG006	SCD-044 Low Dose (Dose 1) to Low Dose (Dose 1)	Subjects initially randomized to SCD-044 low dose continue the same treatment in part II	32	0	32	14	32
EG007	SCD-044 Intermediate Dose (Dose 2) to Intermediate Dose (Dose 2)	Subjects initially randomized to SCD-044 intermediate dose continue the same treatment in part II	36	0	36	13	36
EG008	SCD-044 High Dose (Dose 3) to High Dose (Dose 3)	Subjects initially randomized to SCD-044 high dose continue the same treatment in part II	20	0	20	9	20
EG009	SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)	Subjects initially randomized to low dose re-randomized to SCD-044 tablets of high dose in Part II	20	0	20	6	20
EG010	SCD-044 Intermediate Dose (Dose 2) to High Dose (Dose 3)	Subjects initially randomized to intermediate dose re-randomized to SCD-044 tablets of high dose in Part II	16	0	16	1	16