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Safety, Tolerability and Efficacy of RGH-202 in Social Anxiety Disorder (STAGE) (STAGE)

5. november 2026 oppdatert av: Gedeon Richter Plc.

A Phase 2a, Multicenter, Randomized, Double-blind, Two-arm, Placebo-controlled Clinical Trial to Assess the Safety, Tolerability and Efficacy of RGH-202 for the Management of Performance and Social Interaction Anxiety in Adults With Social Anxiety Disorder

The reason for this trial is to see if the investigational product, called RGH-202, is safe and well tolerated, and can help people with social anxiety disorder.

The main questions this study aims to answer are:

  • Is RGH-202 safe and well tolerated in adults with social anxiety disorder?
  • Does RGH-202 reduce symptoms of social anxiety disorder compared with placebo? RGH-202 will be compared with a placebo (a product that does not contain any active ingredients) to determine whether the investigational medicine may be an effective treatment for SAD.

Participants will have an equal chance of receiving RGH-202 or the placebo taken for 6 weeks.

Participants will attend regular clinic visits for safety assessments, study evaluations and complete questionnaires related to their social anxiety symptoms.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

156

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • California
      • Encino, California, Forente stater, 91316
    • Florida
      • Jacksonville, Florida, Forente stater, 32256
        • Clinical Neuroscience Solutions, LLC
        • Ta kontakt med:
      • Orlando, Florida, Forente stater, 32801
        • Clinical Neuroscience Solutions, LLC
        • Ta kontakt med:
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89119
    • New York
      • Brooklyn, New York, Forente stater, 11229
        • Integrative Clinical Trials, LLC
        • Ta kontakt med:
    • North Carolina
      • Charlotte, North Carolina, Forente stater, 28211
        • New Hope Clinical Research Inc.
        • Ta kontakt med:
    • Tennessee
      • Memphis, Tennessee, Forente stater, 38119
        • Clinical Neuroscience Solutions, LLC
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion criteria:

  • Adults aged 18 to 65 years.
  • Otherwise healthy participants without clinically significant medical abnormalities.
  • Primary DSM-5-TR diagnosis of Social Anxiety Disorder (SAD), confirmed by structured diagnostic interview.
  • Body weight ≥40 kg and BMI 18.5-36.6 kg/m².
  • Participants of reproductive potential must agree to protocol-defined contraception requirements; women of childbearing potential must have negative pregnancy testing.
  • Able and willing to provide informed consent.
  • Able to understand study procedures and comply with study requirements.
  • LSAS total score ≥70 at Screening and Baseline.
  • Fluent in English and able to complete study assessments.
  • Able to swallow oral capsules.

Exclusion criteria:

  • Current primary psychiatric disorder other than SAD.
  • MADRS score ≥24.
  • History of schizophrenia spectrum disorder, bipolar disorder, clinically significant personality disorder, or other psychiatric conditions judged likely to interfere with study participation.
  • Current OCD, PTSD, panic disorder, or eating disorder.
  • Moderate to severe alcohol use disorder or substance use disorder within the previous 12 months.
  • Any clinically significant medical or psychiatric condition that may increase risk or interfere with study participation.
  • Clinically significant abnormal medical history, examination, laboratory, or ECG findings.
  • Moderate to severe renal impairment (eGFR <50 mL/min).
  • Family history of congenital long QT syndrome, Brugada syndrome, or unexplained sudden cardiac death.
  • Clinically significant QTc prolongation.
  • Clinically significant cardiac conduction abnormalities.
  • Family history of seizures.
  • History of seizure disorder or conditions associated with increased seizure risk.
  • Clinically significant chronic neurological disorder or chronic pain condition.
  • Current suicidal ideation, recent suicidal ideation, or lifetime suicide attempt.
  • Clinically significant laboratory abnormalities.
  • Clinically significant abnormal vital signs.
  • ALT, AST, or ALP >2× ULN.
  • Total bilirubin >1.5× ULN.
  • Current or chronic clinically significant liver disease.
  • Recent or ongoing treatment with anxiolytics, including benzodiazepines.
  • Recent or ongoing treatment with antidepressants, antipsychotics, mood stabilizers, stimulants, anticonvulsants, acetylcholinesterase inhibitors, or other psychotropic medications.
  • Recent use of medications or substances used to treat anxiety symptoms.
  • Concomitant medications that may interfere with study participation or interpretation.
  • Use of medications known to prolong QT interval.
  • Use of herbal or dietary supplements or recent initiation of herbal supplements with known hepatotoxic potential.
  • Use of medications that significantly affect CYP metabolism or drug disposition.
  • Recent use of strong CYP2D6 inhibitors.
  • Use of medications that are sensitive CYP3A4 substrates.
  • Current psychotherapy specifically targeting social anxiety disorder.
  • Participation in neuromodulation therapy.
  • Participation in another interventional clinical trial within the previous 3 months.
  • Positive HIV, hepatitis B, or hepatitis C test.
  • Positive drug screen or cannabis use.
  • Positive alcohol test at screening or baseline.
  • Positive pregnancy test.
  • Current excessive alcohol consumption.
  • Known hypersensitivity to study medication or excipients.
  • Lactation or breastfeeding.
  • Medical condition or prior surgery that may affect drug absorption.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Group receiving RGH-202

Oral capsule dosage form applied once daily for 42 days
Legemiddel: RGH-202

Oral capsule dosage form applied once daily for 42 days
Placebo komparator: Group receiving Placebo

Oral capsule dosage form applied once daily for 42 days
Legemiddel: Placebo

Oral capsule dosage form applied once daily for 42 days

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Incidence and severity of adverse events
Tidsramme: From enrollment to the end of follow-up at 8 week
From enrollment to the end of follow-up at 8 week

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from baseline in performance and social interaction anxiety measured by the SUDS during structured speaking task and severity of social anxiety disorder measured by the LSAS to Week 4 and Week 6, respectively, vs placebo
Tidsramme: From baseline to week 4 and 6, respectively

SUDS: Subjective Units of Distress Scale; LSAS: Liebowitz Social Anxiety Scale
From baseline to week 4 and 6, respectively

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Gedeon Richter Plc.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

12. november 2026

Primær fullføring (Antatt)

13. februar 2028

Studiet fullført (Antatt)

13. februar 2028

Datoer for studieregistrering

Først innsendt

29. oktober 2026

Først innsendt som oppfylte QC-kriteriene

5. november 2026

Først lagt ut (Faktiske)

12. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • RGH-202-002

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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