ClinicalTrials.gg
Not yet recruitingNCT07931703STAGEUpdated Nov 12, 2026

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

A Phase 2 interventional study of RGH-202 and Placebo in Social Anxiety Disorder, sponsored by Gedeon Richter Plc.. Not yet recruiting at 7 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by Gedeon Richter Plc. · Phase 2, Interventional, and Treatment

Updated Nov 12, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
156
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 187 studies in Phobia, Social with a site in United States — 23 open to participants now, 29 under way, 1 of them phase 3. Phobia, Social · United States.

Planned enrollment
45th of 178
156 · median 64
Started
2026
with 4 others
Phase 2
25 of 187
2 open now
Primary completion
2028-02
later than 19 of 28 live
Registered
187th of 187
by date

Among the 187 studies in Phobia, Social with a site in United States, this one is the 45th largest by planned enrollment of the 178 interventional ones that give a count, is one of 5 that started in 2026, is one of 25 in phase 2, reaches primary completion later than 19 of the 28 other live ones, and was the 187th registered.

Phobia, Social

368 studies on the registry are indexed under Phobia, Social; 59 are open to participants now.

Browse Phobia, Social studies →

Open to participants now

23 of the 187 studies in Phobia, Social with a site in United States are open now. Recruiting first, the newest first:

18 more — sign in →

All 23 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 46 Phobia, Social studies recruiting now, 10 (22%) set no upper age limit and 34 (74%) stop at 75 or younger; 14 take children under 18; 8 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 187 studies in Phobia, Social with a site in United States, or all of them as a file.
02

Study summary

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.

03

Conditions studied

  • Social Anxiety Disorder

Browse trials for

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults aged 18 to 65 years.
  • Otherwise healthy participants without medical abnormalities.
  • Primary diagnosis of Social Anxiety Disorder (SAD), confirmed by structured diagnostic interview.
  • Body weight ≥40 kg and 18.5-36.6 kg/m².
  • Participants of must agree to protocol-defined requirements; women of must have negative pregnancy testing.
  • Able and willing to provide .
  • 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

Exclusion criteria:

  • Current primary psychiatric disorder other than SAD.
  • MADRS score ≥24.
  • History of schizophrenia spectrum disorder, bipolar disorder, 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 findings.
  • Moderate to severe renal impairment ( \<50 mL/min).
  • Family history of congenital long 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.
  • , AST, or ALP >2× .
  • Total >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 substrates.
  • Current psychotherapy specifically targeting social anxiety disorder.
  • Participation in neuromodulation therapy.
  • Participation in another interventional clinical trial within the previous 3 months.
  • Positive , , or test.
  • Positive drug screen or cannabis use.
  • Positive alcohol test at screening or baseline.
  • Positive pregnancy test.
  • Current excessive alcohol consumption.
  • Known to study medication or .
  • Lactation or breastfeeding.
  • Medical condition or prior surgery that may affect drug absorption.
Terms in these criteria, in plain language(19)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Reproductive potential

Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.

Criteria about it usually ask for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
156 participants (estimated)

Study arms

  • Experimental
    Group receiving RGH-202

    Oral capsule dosage form applied once daily for 42 days

    Drug: RGH-202

  • Placebo comparator
    Group receiving Placebo

    Oral capsule dosage form applied once daily for 42 days

    Drug: Placebo

Interventions

  • DrugRGH-202

    Oral capsule dosage form applied once daily for 42 days

  • DrugPlacebo

    Oral capsule dosage form applied once daily for 42 days

06

What researchers measure

Primary outcomes

  1. Incidence and severity of adverse events

    Time frame: From enrollment to the end of follow-up at 8 week

Secondary outcomes

  1. 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

    SUDS: Subjective Units of Distress Scale; LSAS: Liebowitz Social Anxiety Scale

    Time frame: From baseline to week 4 and 6, respectively

07

Study locations

7 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Feb 2028, 15 months later.

Of 15 phase 2 interventional studies under Phobia, Social, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 18. This study's planned 15 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 29, 2026
First posted
Nov 12, 2026
StartEst.
Nov 12, 2026
Primary completionEst.
Feb 13, 2028
CompletionEst.
Feb 13, 2028
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07931703
Lead sponsor
Gedeon Richter Plc.
Responsible party
Sponsor
First posted
Nov 12, 2026
Start date
Nov 12, 2026 (estimated)
Primary completion
Feb 13, 2028 (estimated)
Completion
Feb 13, 2028 (estimated)
Last update
Nov 12, 2026

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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