Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Palmoplantar Pustulosis
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RIST4721 | Experimental | RIST4721 as once-daily 300mg oral solution for 28 days. |
|
| Placebo | Placebo Comparator | Placebo as once-daily 300mg oral solution for 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RIST4721 | Drug | RIST4721 oral solution |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Log Transformed Ratio of Postbaseline Fresh Pustule Count at Day 28 to Baseline | Relative change from baseline in fresh pustule count at Day 28 | Baseline to Day 28 |
| Log Transformed Ratio of Postbaseline Total Pustule Count at Day 28 to Baseline | Relative change from baseline in total pustule count at Day 28 | Baseline to Day 28 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kirk Barber Research | Calgary | Alberta | T2G 1B1 | Canada | ||
| Alberta DermaSurgery Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34716902 | Derived | Bissonnette R, Maari C, Tsianakas A, Reid D, McCutchan S, Baumgartner S, Mackay J, Bhakta N. A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Palmoplantar Pustulosis. Dermatol Ther (Heidelb). 2021 Dec;11(6):2179-2193. doi: 10.1007/s13555-021-00632-7. Epub 2021 Oct 30. |
| Label | URL |
|---|---|
| A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Palmoplantar Pustulosis | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Subjects must have at least a 6-month history of PPP and have moderate or severe PPP.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | RIST4721 | Subjects were randomized to receive RIST4721 300 mg oral solution once daily for 28 days. |
| FG001 | Placebo | Subjects were randomized to receive Placebo oral solution once daily for 28 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All subjects who were randomized to either RIST4721 or Placebo
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | RIST4721 | This arm was randomized to receive 300 mg of RIST4721 once daily for 28 days. |
| BG001 | Placebo | This arm was randomized to receive placebo once daily for 28 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Log Transformed Ratio of Postbaseline Fresh Pustule Count at Day 28 to Baseline | Relative change from baseline in fresh pustule count at Day 28 | Posted | Mean | Standard Deviation | Log transformed ratio | Baseline to Day 28 |
|
|
From ICF signature to end of study participation (approximately 73 days)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RIST4721 300 mg | All subjects who received at least one dose of RIST4721 300 mg (Safety Analysis Set). |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA (21.1) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aristea Therapeutics | Aristea Therapeutics | 858-465-6142 | info@aristeatx.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 22, 2019 | Nov 1, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 20, 2019 | Nov 1, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Double-blind
| Drug |
Placebo oral solution |
|
| Edmonton |
| Alberta |
| T6G 1C3 |
| Canada |
| CARe Clinic (Central Alberta Research Clinic) | Red Deer | Alberta | T4N 6V7 | Canada |
| Winnipeg Clinic | Winnipeg | Manitoba | R3C 0N2 | Canada |
| Brunswick Dermatology Center | Fredericton | New Brunswick | E3B 1G9 | Canada |
| SimcoDerm Medical and Surgical Dermatology Center | Barrie | Ontario | L4M 7G1 | Canada |
| Dr. Lyne Giroux Medicine Professional Corporation | Greater Sudbury | Ontario | P3A 1W8 | Canada |
| Lynderm Research Inc. | Markham | Ontario | L3P 1X2 | Canada |
| North Bay Dermatology Centre | North Bay | Ontario | P1B 3Z7 | Canada |
| York Dermatology Center | Richmond Hill | Ontario | L4C 9M7 | Canada |
| Innovaderm Research Inc. | Montreal | Quebec | H2X 2V1 | Canada |
| Dre Angelique Gagne-Henley MD Inc. | Saint-Jérôme | Quebec | J7Z 3B8 | Canada |
| Fachklinik Bad Bentheim | Bad Bentheim | 48455 | Germany |
| Rothhaar Studien GmbH | Berlin | 10783 | Germany |
| Hautarztpraxis Dr. Niesmann & Dr. Othlinghaus | Bochum | 44793 | Germany |
| MensingDerma research GmbH | Hamburg | 22391 | Germany |
| Hautarztpraxis Dr. Wilfried Steinborn | Straubing | 94315 | Germany |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Primary | Log Transformed Ratio of Postbaseline Total Pustule Count at Day 28 to Baseline | Relative change from baseline in total pustule count at Day 28 | Posted | Mean | Standard Deviation | Log transformed ratio | Baseline to Day 28 |
|
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 13 |
| 15 |
| EG001 | Placebo | All subjects who received at least one dose of Placebo (Safety Analysis Set). | 0 | 19 | 0 | 19 | 7 | 19 |
| Anxiety | Psychiatric disorders | MedDRA (21.1) | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (21.1) | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
|
| Bacterial test | Investigations | MedDRA (21.1) | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA (21.1) | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA (21.1) | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA (21.1) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (21.1) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (21.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Abnormal faeces | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Urine odour abnormal | Renal and urinary disorders | MedDRA (21.1) | Systematic Assessment |
|
| Micturition disorder | Renal and urinary disorders | MedDRA (21.1) | Systematic Assessment |
|
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
|
| Post procedural cellulitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
|
Not provided
Not provided