Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Design Trial to Evaluate the Safety and Efficacy of Denifanstat in Participants With Moderate to Severe Acne Vulgaris
The purpose of this study is to evaluate the safety and efficacy of denifanstat compared with matching placebo in participants with moderate to severe acne vulgaris who are ≥12 years of age. After the 12-week treatment phase, a subset of approximately 530 participants will have the option to consent to an open-label extension phase for an additional 40 weeks of treatment.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 3
Kontakter og lokationer
Studiekontakt
- Navn: Study Director
- Telefonnummer: (650) 561-8675
- E-mail: clinicalhotline@sagimet.com
Studiesteder
-
-
Arkansas
-
Bryant, Arkansas, Forenede Stater, 72022
- Rekruttering
- Sagimet Investigative Site
-
-
California
-
Beverly Hills, California, Forenede Stater, 90211
- Rekruttering
- Sagimet Investigative Site
-
Fremont, California, Forenede Stater, 94538
- Rekruttering
- Sagimet Investigative Site
-
San Diego, California, Forenede Stater, 92123
- Rekruttering
- Sagimet Investigative Site
-
Santa Ana, California, Forenede Stater, 92705
- Rekruttering
- Sagimet Investigative Site
-
-
Florida
-
Doral, Florida, Forenede Stater, 33126
- Rekruttering
- Sagimet Investigative Site
-
Fort Lauderdale, Florida, Forenede Stater, 33308
- Rekruttering
- Sagimet Investigative Site
-
Miami, Florida, Forenede Stater, 33125
- Rekruttering
- Sagimet Investigative Site
-
Miami, Florida, Forenede Stater, 33126
- Rekruttering
- Sagimet Investigative Site
-
Miami, Florida, Forenede Stater, 33175
- Rekruttering
- Sagimet Investigative Site
-
Miramar, Florida, Forenede Stater, 33027
- Rekruttering
- Sagimet Investigative Site
-
Sweetwater, Florida, Forenede Stater, 33182
- Rekruttering
- Sagimet Investigative Site
-
-
Illinois
-
Lincolnshire, Illinois, Forenede Stater, 60069
- Rekruttering
- Sagimet Investigative Site
-
-
Indiana
-
Indianapolis, Indiana, Forenede Stater, 46250
- Rekruttering
- Sagimet Investigative Site
-
New Albany, Indiana, Forenede Stater, 47150
- Rekruttering
- Sagimet Investigative Site
-
-
Michigan
-
Clinton Township, Michigan, Forenede Stater, 48038
- Rekruttering
- Sagimet Investigative Site
-
-
Nebraska
-
Omaha, Nebraska, Forenede Stater, 68144
- Rekruttering
- Sagimet Investigative Site
-
-
New Hampshire
-
Portsmouth, New Hampshire, Forenede Stater, 03801
- Rekruttering
- Sagimet Investigative Site
-
-
New Jersey
-
Robbinsville, New Jersey, Forenede Stater, 08691
- Rekruttering
- Sagimet Investigative Site
-
-
North Carolina
-
Wilmington, North Carolina, Forenede Stater, 28045
- Rekruttering
- Sagimet Investigative Site
-
-
Ohio
-
Columbus, Ohio, Forenede Stater, 43215
- Rekruttering
- Sagimet Investigative Site
-
-
Rhode Island
-
East Greenwich, Rhode Island, Forenede Stater, 02818
- Rekruttering
- Sagimet Investigative Site
-
-
South Carolina
-
Greenville, South Carolina, Forenede Stater, 29615
- Rekruttering
- Sagimet Investigative Site
-
-
Tennessee
-
Murfreesboro, Tennessee, Forenede Stater, 37130
- Rekruttering
- Sagimet Investigative Site
-
Nashville, Tennessee, Forenede Stater, 37215
- Rekruttering
- Sagimet Investigative Site
-
-
Texas
-
College Station, Texas, Forenede Stater, 77845
- Rekruttering
- Sagimet Investigative Site
-
El Paso, Texas, Forenede Stater, 79902
- Rekruttering
- Sagimet Investigative Site
-
-
Washington
-
Spokane, Washington, Forenede Stater, 99202
- Rekruttering
- Sagimet Investigative Site
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
-
Must be willing and able to participate in the trial and provide written informed consent or assent
-
Aged ≥12 years on the date that written informed consent/ assent is provided
-
Moderate to severe acne vulgaris based on the following criteria at screening:
-
The EGSS at screening of 3 or 4.
AND
-
Number of facial skin lesions:
- 30 to 75 inflammatory lesions
- 30 to 100 noninflammatory lesions
-
-
All participants with their partners, if any, must agree to the use of an acceptable method of highly effective contraception. Women of childbearing potential (WOCBP) must not be pregnant or breastfeeding, must not plan to become pregnant during the study, and must use 2 forms of birth control, one being a barrier method, or be sexually abstinent.
Exclusion Criteria:
-
Presence of >2 facial cysts/ nodules
-
Cystic acne, acne fulminans or acne conglobata
-
Other significant skin diseases that may affect the efficacy evaluation or require co-treatment
-
History of clinically significant dry eye, such as Ocular Surface Disease Index (OSDI) ≥33, or corneal staining ≥ grade III on Oxford Grading Scale, chronic dry eye, or other corneal abnormality
-
Use of concomitant strong cytochrome P450 (CYP) 3A4 inducers and strong or moderate inhibitors within 2 weeks prior to Day 1 the trial except Paxlovid®
-
Use of a glucagon-like-peptide 1 (GLP-1) agonist for <12 weeks prior to first dose of trial medication
-
Use of any of the following:
- Introduction of any drug known to prolong QT interval corrected for heart rate (QTC)
- Sensitive substrates of P-glycoprotein (P-gp) and breast cancer resistant protein (BCRP)
- Herbs and supplements such as St John's Wort or grapefruit juice.
-
Use of concomitant acne treatments unless appropriate washout period is documented
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: Placebo
|
Oral, once daily |
|
Eksperimentel: Denifanstat
|
Oral, once daily |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Proportion of participants achieving EGSS success, defined as a score of 0 (clear) or 1 (almost clear) with at least a 2-point decrease from their baseline score
Tidsramme: Week 12
|
Week 12
|
|
Absolute change from baseline in inflammatory lesion count (ILC)
Tidsramme: Week 12
|
Week 12
|
|
Absolute change from baseline in non-inflammatory lesion count (ILC)
Tidsramme: Week 12
|
Week 12
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Safety and tolerability (Open-Label Extension)
Tidsramme: Week 52
|
Incidence of treatment-emergent adverse events and serious adverse events; change from baseline in safety parameters |
Week 52
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SB2640-CLIN-017
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .