A Phase 2b Study to Evaluate RIST4721 in Palmoplantar Pus... | NCT05194839

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RIST4721 400 mg	Experimental	RIST4721 400 mg: 4 active (100 mg) tablets once daily for 12 weeks	Drug: RIST4721
RIST4721 200 mg	Experimental	RIST4721 200 mg: 2 active (100 mg) tablets + 2 placebo tablets once daily for 12 weeks	Drug: RIST4721 Drug: Placebo
Placebo	Placebo Comparator	Placebo: 4 placebo tablets once daily for 12 weeks	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
RIST4721	Drug	RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets	RIST4721 200 mg RIST4721 400 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of Subjects Achieving a 50% Reduction in PPPASI Score	In the Palmoplantar Pustulosis Psoriasis Area and Severity Index (PPPASI), the left palm, right palm, left foot, and right foot are assessed based on 3 target symptoms: erythema, desquamation (scaling), and pustules, as seen on the day of the examination. The severity of each sign is assessed using a 5-point scale (0 = not present, 1 = slight, 3 = moderate, 4 = severe, 5 = very severe). The affected area within a given anatomic site (left palm, right palm, left foot, and right foot) is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of PPP involvement (0 = no involvement, 2 = 10 to less than 30% involvement, 3 = 30 to less than 50% involvement, 4 = 50 to less than 70% involvement, 5 = 70 to less than 90% involvement, 6 = 90 to less than 100% involvement). PPPASI score for palms and soles is obtained using a formula and can vary from 0 (absence of disease) to 72 (most severe disease).	Baseline to Week 12

Measure	Description	Time Frame
Absolute Change From Baseline in PPPGA		Baseline to Week 12
Absolute Change From Baseline in PPPASI		Baseline to Week 12

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
Total Skin & Beauty Dermatology Center, PC		Birmingham	Alabama	35205	United States
Dermatology Trial Associates

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	RIST4721 400 mg	RIST4721 400 mg: 4 active (100 mg) tablets once daily for 12 weeks RIST4721: RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets
FG001	RIST4721 200 mg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 5, 2022	Jun 7, 2023

Arm/Group Information

ID	Title	Description
BG000	RIST4721 400 mg	RIST4721 400 mg: 4 active (100 mg) tablets once daily for 12 weeks RIST4721: RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets
BG001	RIST4721 200 mg	RIST4721 200 mg: 2 active (100 mg) tablets + 2 placebo tablets once daily for 12 weeks RIST4721: RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets
BG002	Placebo	Placebo: 4 placebo tablets once daily for 12 weeks
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00023 BG00123 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

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 Achieving a 50% Reduction in PPPASI Score

In the Palmoplantar Pustulosis Psoriasis Area and Severity Index (PPPASI), the left palm, right palm, left foot, and right foot are assessed based on 3 target symptoms: erythema, desquamation (scaling), and pustules, as seen on the day of the examination. The severity of each sign is assessed using a 5-point scale (0 = not present, 1 = slight, 3 = moderate, 4 = severe, 5 = very severe). The affected area within a given anatomic site (left palm, right palm, left foot, and right foot) is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of PPP involvement (0 = no involvement, 2 = 10 to less than 30% involvement, 3 = 30 to less than 50% involvement, 4 = 50 to less than 70% involvement, 5 = 70 to less than 90% involvement, 6 = 90 to less than 100% involvement). PPPASI score for palms and soles is obtained using a formula and can vary from 0 (absence of disease) to 72 (most severe disease).

Posted

Count of Participants

Participants

Baseline to Week 12

ID	Title	Description
OG000	RIST4721 400 mg	RIST4721 400 mg: 4 active (100 mg) tablets once daily for 12 weeks RIST4721: RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets
OG001	RIST4721 200 mg	RIST4721 200 mg: 2 active (100 mg) tablets + 2 placebo tablets once daily for 12 weeks RIST4721: RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets
OG002	Placebo	Placebo: 4 placebo tablets once daily for 12 weeks

Units	Counts
Participants	OG00012 OG00113 OG00212

Title

Denominators

Categories

Title	Measurements
	OG0006 OG0013 OG0025

Secondary

Absolute Change From Baseline in PPPGA

Not Posted

Baseline to Week 12

Participants

Secondary

Absolute Change From Baseline in PPPASI

Not Posted

Baseline to Week 12

Participants

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	RIST4721 400 mg	RIST4721 400 mg: 4 active (100 mg) tablets once daily for 12 weeks RIST4721: RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets	27	0	27	18	27
EG001	RIST4721 200 mg	RIST4721 200 mg: 2 active (100 mg) tablets + 2 placebo tablets once daily for 12 weeks RIST4721: RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets	26	1	26	17	26
EG002	Placebo	Placebo: 4 placebo tablets once daily for 12 weeks	26	0	26	18	26

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	Systematic Assessment	EG0001 affected27 at risk EG0013 affected26 at risk EG0024 affected26 at risk
Urinary Tract Infection	Infections and infestations	Systematic Assessment	EG0001 affected27 at risk EG0011 affected26 at risk EG0021 affected26 at risk
Covid-19	Infections and infestations	Systematic Assessment	EG0001 affected27 at risk EG0010 affected26 at risk EG0021 affected26 at risk
Upper respiratory tract infection	Infections and infestations	Systematic Assessment	EG0001 affected27 at risk EG0010 affected26 at risk EG0021 affected26 at risk
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0004 affected27 at risk EG0011 affected26 at risk EG0020 affected26 at risk
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0002 affected27 at risk EG0010 affected26 at risk EG0020 affected26 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0001 affected27 at risk EG0011 affected26 at risk EG0020 affected26 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0002 affected27 at risk EG0010 affected26 at risk EG0020 affected26 at risk
Alanine aminotransferase increased	Investigations	Systematic Assessment	EG0000 affected27 at risk EG0012 affected26 at risk EG0020 affected26 at risk
C-reactive protein increased	Investigations	Systematic Assessment	EG0002 affected27 at risk EG0010 affected26 at risk EG0020 affected26 at risk
Psoriasis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 affected27 at risk EG0010 affected26 at risk EG0021 affected26 at risk
Headache	Nervous system disorders	Systematic Assessment	EG0003 affected27 at risk EG0011 affected26 at risk EG0021 affected26 at risk
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected27 at risk EG0010 affected26 at risk EG0022 affected26 at risk
Fatigue	General disorders	Systematic Assessment	EG0001 affected27 at risk EG0011 affected26 at risk EG0021 affected26 at risk
Urine odor abnormal	Renal and urinary disorders	Systematic Assessment	EG0001 affected27 at risk EG0013 affected26 at risk EG0020 affected26 at risk
Hypertension	Vascular disorders	Systematic Assessment	EG0002 affected27 at risk EG0010 affected26 at risk EG0021 affected26 at risk
Asymptomatic COVID-19	Infections and infestations	Systematic Assessment	EG0001 affected27 at risk EG0010 affected26 at risk EG0020 affected26 at risk
Asymptomatic bacteriuria	Infections and infestations	Systematic Assessment	EG0000 affected27 at risk EG0010 affected26 at risk EG0021 affected26 at risk
Bacterial vaginosis	Infections and infestations	Systematic Assessment	EG0001 affected27 at risk EG0010 affected26 at risk EG0020 affected26 at risk
Bronchitis	Infections and infestations	Systematic Assessment	EG0000 affected27 at risk EG0010 affected26 at risk EG0021 affected26 at risk
Cystitis bacterial	Infections and infestations	Systematic Assessment	EG0001 affected27 at risk EG0010 affected26 at risk EG0020 affected26 at risk
Fungal skin infection	Infections and infestations	Systematic Assessment	EG0000 affected27 at risk EG0011 affected26 at risk EG0020 affected26 at risk
Furuncle	Infections and infestations	Systematic Assessment	EG0000 affected27 at risk EG0011 affected26 at risk EG0020 affected26 at risk
Periodontitis	Infections and infestations	Systematic Assessment	EG0000 affected27 at risk EG0010 affected26 at risk EG0021 affected26 at risk
Respiratory tract infection	Infections and infestations	Systematic Assessment	EG0000 affected27 at risk EG0011 affected26 at risk EG0020 affected26 at risk
Rhinitis	Infections and infestations	Systematic Assessment	EG0000 affected27 at risk EG0010 affected26 at risk EG0021 affected26 at risk
Sinusitis	Infections and infestations	Systematic Assessment	EG0000 affected27 at risk EG0010 affected26 at risk EG0021 affected26 at risk
Tonsillitis	Infections and infestations	Systematic Assessment	EG0001 affected27 at risk EG0010 affected26 at risk EG0020 affected26 at risk
Viral diarrhoea	Infections and infestations	Systematic Assessment	EG0000 affected27 at risk EG0010 affected26 at risk EG0021 affected26 at risk
Abnormal faeces	Gastrointestinal disorders	Systematic Assessment	EG0000 affected27 at risk EG0011 affected26 at risk EG0020 affected26 at risk
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0000 affected27 at risk EG0011 affected26 at risk EG0020 affected26 at risk
Dry mouth	Gastrointestinal disorders	Systematic Assessment	EG0000 affected27 at risk EG0011 affected26 at risk EG0020 affected26 at risk
Flatulence	Gastrointestinal disorders	Systematic Assessment	EG0000 affected27 at risk EG0011 affected26 at risk EG0020 affected26 at risk
Haemorrhoids	Gastrointestinal disorders	Systematic Assessment	EG0001 affected27 at risk EG0010 affected26 at risk EG0020 affected26 at risk
Inguinal hernia	Gastrointestinal disorders	Systematic Assessment	EG0000 affected27 at risk EG0010 affected26 at risk EG0021 affected26 at risk
Aspartate aminotransferase increased	Investigations	Systematic Assessment	EG0000 affected27 at risk EG0011 affected26 at risk EG0020 affected26 at risk
Urine leukocyte esterase positive	Investigations	Systematic Assessment	EG0000 affected27 at risk EG0010 affected26 at risk EG0021 affected26 at risk
Weight decreased	Investigations	Systematic Assessment	EG0001 affected27 at risk EG0010 affected26 at risk EG0020 affected26 at risk
White blood cell count increased	Investigations	Systematic Assessment	EG0001 affected27 at risk EG0010 affected26 at risk EG0020 affected26 at risk
Diffuse alopecia	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected27 at risk EG0010 affected26 at risk EG0021 affected26 at risk
Hand dermatitis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected27 at risk EG0010 affected26 at risk EG0021 affected26 at risk
Palmoplantar pustulosis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected27 at risk EG0011 affected26 at risk EG0020 affected26 at risk
Petechiae	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected27 at risk EG0010 affected26 at risk EG0021 affected26 at risk
Pruritus	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected27 at risk EG0010 affected26 at risk EG0021 affected26 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected27 at risk EG0010 affected26 at risk EG0021 affected26 at risk
Invertebral disc protrusion	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected27 at risk EG0010 affected26 at risk EG0021 affected26 at risk
Neck pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected27 at risk EG0011 affected26 at risk EG0020 affected26 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected27 at risk EG0010 affected26 at risk EG0020 affected26 at risk
Dysaesthesia	Nervous system disorders	Systematic Assessment	EG0000 affected27 at risk EG0010 affected26 at risk EG0021 affected26 at risk
Vertigo	Nervous system disorders	Systematic Assessment	EG0001 affected27 at risk EG0010 affected26 at risk EG0020 affected26 at risk
Pyrexia	General disorders	Systematic Assessment	EG0001 affected27 at risk EG0010 affected26 at risk EG0020 affected26 at risk
Xerosis	General disorders	Systematic Assessment	EG0000 affected27 at risk EG0010 affected26 at risk EG0021 affected26 at risk
Haematuria	Renal and urinary disorders	Systematic Assessment	EG0001 affected27 at risk EG0010 affected26 at risk EG0020 affected26 at risk
Anaemia macrocytic	Blood and lymphatic system disorders	Systematic Assessment	EG0001 affected27 at risk EG0010 affected26 at risk EG0020 affected26 at risk
Neutropenia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 affected27 at risk EG0010 affected26 at risk EG0020 affected26 at risk
Blepharitis	Eye disorders	Systematic Assessment	EG0000 affected27 at risk EG0011 affected26 at risk EG0020 affected26 at risk
Vision blurred	Eye disorders	Systematic Assessment	EG0000 affected27 at risk EG0011 affected26 at risk EG0020 affected26 at risk
Bronchitis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected27 at risk EG0010 affected26 at risk EG0020 affected26 at risk
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected27 at risk EG0010 affected26 at risk EG0021 affected26 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected27 at risk EG0010 affected26 at risk EG0021 affected26 at risk
Bundle branch block left	Cardiac disorders	Systematic Assessment	EG0000 affected27 at risk EG0010 affected26 at risk EG0021 affected26 at risk
Hepatic enzyme increased	Investigations	Systematic Assessment	EG0000 affected27 at risk EG0012 affected26 at risk EG0020 affected26 at risk
Ligament rupture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected27 at risk EG0010 affected26 at risk EG0021 affected26 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected27 at risk EG0010 affected26 at risk EG0020 affected26 at risk
Ovarian cyst	Reproductive system and breast disorders	Systematic Assessment	EG0001 affected27 at risk EG0010 affected26 at risk EG0020 affected26 at risk
Tooth extraction	Surgical and medical procedures	Systematic Assessment	EG0000 affected27 at risk EG0011 affected26 at risk EG0020 affected26 at risk

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Hepatic lesion	Hepatobiliary disorders		Systematic Assessment		EG0000 events0 affected27 at risk EG0011 events1 affected26 at risk EG0020 events0 affected26 at risk
Blood bilirubin increased	Investigations		Systematic Assessment		EG0000 events0 affected27 at risk EG0011 events1 affected26 at risk EG0020 events0 affected26 at risk