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NCT03988335

A Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)

Completed Phase 2 Results posted Last updated 5 April 2022
What this trial tests

Phase 2 trial testing RIST4721 in Palmoplantar Pustulosis in 35 participants. Completed in 19 November 2019.

Timeline
13 February 2019
Primary endpoint
5 November 2019
19 November 2019

Quick facts

Lead sponsorAristea Therapeutics, Inc.
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment35
Start date13 February 2019
Primary completion5 November 2019
Estimated completion19 November 2019
Sites17 locations across Canada, Germany

Drugs / interventions tested

Conditions studied

Sponsor

Aristea Therapeutics, Inc. — full company profile →

Who can join

Adults 18 to 70, any sex, with Palmoplantar Pustulosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Log Transformed Ratio of Postbaseline Fresh Pustule Count at Day 28 to Baseline Primary · Baseline to Day 28

Relative change from baseline in fresh pustule count at Day 28

GroupValue95% CI
RIST4721 300 mg0.86± 0.692
Placebo0.53± 0.561
Log Transformed Ratio of Postbaseline Total Pustule Count at Day 28 to Baseline Primary · Baseline to Day 28

Relative change from baseline in total pustule count at Day 28

GroupValue95% CI
RIST4721 300 mg0.99± 0.667
Placebo0.96± 0.672

Adverse events — posted to ClinicalTrials.gov

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.

RIST4721 300 mg
Serious: 0/15 (0%)
Deaths: 0/15
Placebo
Serious: 0/19 (0%)
Deaths: 0/19
Other adverse events (32 terms — click to expand)

ReactionSystemRIST4721 300 mgPlacebo
DiarrhoeaGastrointestinal disorders
Urine odour abnormalRenal and urinary disorders
Procedural painInjury, poisoning and procedural complications
NeutropeniaBlood and lymphatic system disorders
DizzinessNervous system disorders
Abnormal faecesGastrointestinal disorders
NauseaGastrointestinal disorders
Musculoskeletal stiffnessMusculoskeletal and connective tissue disorders
FolliculitisInfections and infestations
FatigueGeneral disorders
AnxietyPsychiatric disorders
Vaginal haemorrhageReproductive system and breast disorders
Ligament sprainInjury, poisoning and procedural complications
ConcussionInjury, poisoning and procedural complications
Bacterial testInvestigations
Blood glucose increasedInvestigations
Blood triglycerides increasedInvestigations
Hepatic enzyme increasedInvestigations
LeukopeniaBlood and lymphatic system disorders
CoughRespiratory, thoracic and mediastinal disorders
HeadacheNervous system disorders
Abdominal painGastrointestinal disorders
Micturition disorderRenal and urinary disorders
Skin fissuresSkin and subcutaneous tissue disorders
Pain in extremityMusculoskeletal and connective tissue disorders
MyalgiaMusculoskeletal and connective tissue disorders
OsteoarthritisMusculoskeletal and connective tissue disorders
Back painMusculoskeletal and connective tissue disorders
Decreased appetiteMetabolism and nutrition disorders
Increased appetiteMetabolism and nutrition disorders
NasopharyngitisInfections and infestations
Post procedural cellulitisInfections and infestations

Data from ClinicalTrials.gov NCT03988335 adverse events section.

Sponsor's own description

A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Palmoplantar Pustulosis

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The chemokines CXCL8 and CXCL12: molecular and functional properties, role in disease and efforts towards pharmacological intervention.
    Cambier S, Gouwy M, Proost P. · · 2023 · cited 387× · PMID 36725964 · DOI 10.1038/s41423-023-00974-6
  2. Palmoplantar Pustulosis: Recent Advances in Etiopathogenesis and Emerging Treatments.
    Misiak-Galazka M, Zozula J, Rudnicka L. · · 2020 · cited 79× · PMID 32008176 · DOI 10.1007/s40257-020-00503-5
  3. Pustular Psoriasis: From Pathophysiology to Treatment.
    Genovese G, Moltrasio C, Cassano N, Maronese CA, et al · · 2021 · cited 40× · PMID 34944562 · DOI 10.3390/biomedicines9121746
  4. A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Palmoplantar Pustulosis.
    Bissonnette R, Maari C, Tsianakas A, Reid D, et al · · 2021 · cited 11× · PMID 34716902 · DOI 10.1007/s13555-021-00632-7

Verify or expand the search:

Other trials of RIST4721

Trials testing the same drug.

Other recruiting trials for Palmoplantar Pustulosis

Currently open trials in the same condition.

Other Aristea Therapeutics, Inc. trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03988335.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing