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Due to safety findings in ongoing Phase 2 trials.
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A Randomized, Double-blinded, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Hidradenitis Suppurativa
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RIST4721 400 mg | Experimental | RIST4721 400 mg: 4 active (100 mg) tablets once daily for 12 weeks |
|
| Placebo | Placebo Comparator | Placebo: 4 placebo tablets once daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RIST4721 | Drug | RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of TEAEs | Baseline to Week 12 (or end of study participation) | |
| Incidence of SAEs | Baseline to Week 12 (or end of study participation) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Achieving HiSCR50 at Week 12 | Baseline to Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cahaba Dermatology & Skin Center | Birmingham | Alabama | 35244 | United States | ||
| Investigate MD, LLC |
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| 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 | Placebo | Placebo: 4 placebo tablets once daily for 12 weeks Placebo: Matching placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| 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 | Placebo |
| 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 | Incidence of TEAEs | Subjects with at least one TEAE | Posted | Count of Participants | Participants | Baseline to Week 12 (or end of study participation) |
|
|
From ICF signature to end of study participation.
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| ID | Title | Description | Deaths (Affected) | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Migraine | Nervous system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain lower | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aristea Therapeutics | Aristea Therapeutics | 858-465-6142 | info@aristeatx.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 11, 2022 | May 18, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 21, 2023 | May 18, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| Placebo |
| Drug |
Matching placebo |
|
| Scottsdale |
| Arizona |
| 85255 |
| United States |
| USC IDS Pharmacy | Los Angeles | California | 90033 | United States |
| Florida Academic Centers Research and Education, LLC | Coral Gables | Florida | 33134 | United States |
| ForCare Clinical Research | Tampa | Florida | 33613 | United States |
| The Indiana Clinical Trials Center, P.C. | Plainfield | Indiana | 46168 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Wright State Physicians | Fairborn | Ohio | 45324 | United States |
| Progressive Clinical Research | San Antonio | Texas | 78213 | United States |
| Virginia Clinical Research, Inc. | Norfolk | Virginia | 23502 | United States |
| Enverus Medical Research | Surrey | British Columbia | V3V 0C6 | Canada |
| SKiN Health | Cobourg | Ontario | K9A 0Z4 | Canada |
| Lost to Follow-up |
|
| Adverse Event |
|
| Other |
|
Placebo: 4 placebo tablets once daily for 12 weeks
Placebo: Matching placebo
| 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 |
|
| Counts |
|---|
| Participants |
|
|
| Primary | Incidence of SAEs | Subjects with at least one SAE | Posted | Count of Participants | Participants | Baseline to Week 12 (or end of study participation) |
|
|
|
| Secondary | Proportion of Subjects Achieving HiSCR50 at Week 12 | Subjects who completed Week 12 | Posted | Count of Participants | Participants | Baseline to Week 12 |
|
|
|
| 0 |
| 17 |
| 1 |
| 17 |
| 9 |
| 17 |
| EG001 | Placebo | Placebo: 4 placebo tablets once daily for 12 weeks Placebo: Matching placebo | 0 | 8 | 1 | 8 | 4 | 8 |
| Obstructive pancreatitis | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Chest pain | General disorders | Systematic Assessment |
|
| COVID-19 | Infections and infestations | Systematic Assessment |
|
| Chlamydial infection | Infections and infestations | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Sinusitis | Infections and infestations | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Liver function test increased | Investigations | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Carotid artery aneurysm | Nervous system disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Restless leg syndrome | Nervous system disorders | Systematic Assessment |
|
| Sciatica | Nervous system disorders | Systematic Assessment |
|
| Urine odour abnormal | Renal and urinary disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |