Relative change from baseline in fresh pustule count at Day 28
| Group | Value | 95% CI |
|---|---|---|
| RIST4721 300 mg | 0.86 | ± 0.692 |
| Placebo | 0.53 | ± 0.561 |
Last reviewed · How we verify
A Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)
Phase 2 trial testing RIST4721 in Palmoplantar Pustulosis in 35 participants. Completed in 19 November 2019.
| Lead sponsor | Aristea Therapeutics, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 35 |
| Start date | 13 February 2019 |
| Primary completion | 5 November 2019 |
| Estimated completion | 19 November 2019 |
| Sites | 17 locations across Canada, Germany |
Aristea Therapeutics, Inc. — full company profile →
Adults 18 to 70, any sex, with Palmoplantar Pustulosis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Relative change from baseline in fresh pustule count at Day 28
| Group | Value | 95% CI |
|---|---|---|
| RIST4721 300 mg | 0.86 | ± 0.692 |
| Placebo | 0.53 | ± 0.561 |
Relative change from baseline in total pustule count at Day 28
| Group | Value | 95% CI |
|---|---|---|
| RIST4721 300 mg | 0.99 | ± 0.667 |
| Placebo | 0.96 | ± 0.672 |
Time frame: From ICF signature to end of study participation (approximately 73 days). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | RIST4721 300 mg | Placebo |
|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | — | — |
| Urine odour abnormal | Renal and urinary disorders | — | — |
| Procedural pain | Injury, poisoning and procedural complications | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Abnormal faeces | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | — | — |
| Folliculitis | Infections and infestations | — | — |
| Fatigue | General disorders | — | — |
| Anxiety | Psychiatric disorders | — | — |
| Vaginal haemorrhage | Reproductive system and breast disorders | — | — |
| Ligament sprain | Injury, poisoning and procedural complications | — | — |
| Concussion | Injury, poisoning and procedural complications | — | — |
| Bacterial test | Investigations | — | — |
| Blood glucose increased | Investigations | — | — |
| Blood triglycerides increased | Investigations | — | — |
| Hepatic enzyme increased | Investigations | — | — |
| Leukopenia | Blood and lymphatic system disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Micturition disorder | Renal and urinary disorders | — | — |
| Skin fissures | Skin and subcutaneous tissue disorders | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — |
| Increased appetite | Metabolism and nutrition disorders | — | — |
| Nasopharyngitis | Infections and infestations | — | — |
| Post procedural cellulitis | Infections and infestations | — | — |
Data from ClinicalTrials.gov NCT03988335 adverse events section.
A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Palmoplantar Pustulosis
4 peer-reviewed publications reference this trial (live from Europe PMC):
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