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Sildenafil for Scleroderma (SEPVADIS Trial)

Phase 2
Recruiting
Led By Stephen Mathai, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pulmonary function tests with forced expiratory volume in one second/forced vital capacity (FEV1/FVC) >50% AND either a) total lung capacity (TLC) or forced vital capacity (FVC) > 70% predicted or b) TLC or FVC between 60% and 70% predicted with no more than mild interstitial lung disease on computerized tomography scan of the chest on studies obtained within 6 months of enrollment.
Ventilation perfusion scan or computed tomography with intravenous contrast (CT angiogram) without evidence of chronic thromboembolism at anytime before study entry.
Must not have
Renal failure (creatinine above 2.0) at screening visit.
World Health Organization (WHO) Class IV functional status.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up ongoing until study closes, up to 4 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions

Summary

This trial is testing whether sildenafil is an effective treatment for Scleroderma with mildly elevated pulmonary pressures.

Who is the study for?
This trial is for men and women with Scleroderma who have mildly elevated pulmonary pressures. Participants must meet specific criteria including a diagnosis of SSc, the ability to perform certain lung function tests, and not be severely ill or hospitalized. They should not be on other investigational drugs or PAH therapy recently, nor have significant heart issues or untreated sleep apnea.
What is being tested?
The study is testing sildenafil against a placebo in patients with Scleroderma to see if it can effectively treat mildly elevated pulmonary pressures. It's a Phase II trial where participants are randomly assigned to either the medication or an inactive substance without knowing which one they receive.
What are the potential side effects?
Sildenafil may cause headaches, flushing, indigestion, nasal congestion, dizziness, vision changes like blurring or color tingeing. In rare cases it might lead to more serious effects such as severe allergic reactions or prolonged erections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung function tests show I have more than half the normal breathing capacity.
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My scans show no signs of chronic blood clots.
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I can walk for six minutes without difficulty.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My kidney function is impaired with high creatinine levels.
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I am unable to carry out any physical activity without discomfort.
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I have a heart condition affecting the left side or my heart's pumping ability is reduced.
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I am under 18 years old.
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I am currently in the hospital or very sick.
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I have untreated sleep apnea that affects my daily life.
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I am currently using nitrates for my condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~ongoing until study closes, up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and ongoing until study closes, up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Difference in change in distance walked in 6 minute walk test (6MWT) at 4 months
Secondary study objectives
Nesiritide
Difference in change in distance walked in 6MWT at 12 months
Difference in change in health related quality of life as assessed by the 36-Item Short Form Health Survey (SF36) questionnaire
+6 more

Side effects data

From 2018 Phase 4 trial • 6 Patients • NCT01642407
50%
Bronchitis
50%
Nasopharyngitis
50%
Upper respiratory tract infection
33%
Headache
33%
Epistaxis
33%
Diarrhoea
33%
Gastroenteritis
17%
Eczema
17%
Vision blurred
17%
Rash
17%
Flushing
17%
Alanine aminotransferase increased
17%
Ammonia increased
17%
Aspartate aminotransferase increased
17%
Weight increased
17%
Dysmenorrhoea
17%
Erection increased
17%
Pulmonary arterial hypertension
17%
Rhinitis allergic
17%
Acne
17%
Dermatitis diaper
17%
Dry skin
17%
Visual acuity reduced transiently
17%
Colitis
17%
Molluscum contagiosum
17%
Streptococcal infection
17%
Blood urine present
17%
Myalgia
17%
Cardiac failure
17%
Conjunctivitis allergic
17%
Dental caries
17%
Vomiting
17%
Chest pain
17%
Feeling abnormal
17%
Influenza
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sildenafil

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SildenafilExperimental Treatment1 Intervention
Sildenafil 20 mg by mouth three(3) times each day
Group II: PlaceboPlacebo Group1 Intervention
Placebo by mouth three(3) times each day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sildenafil
FDA approved

Find a Location

Who is running the clinical trial?

United States Department of DefenseFED
916 Previous Clinical Trials
334,687 Total Patients Enrolled
Louisiana State University Health Sciences Center in New OrleansOTHER
120 Previous Clinical Trials
42,714 Total Patients Enrolled
2 Trials studying Scleroderma
86 Patients Enrolled for Scleroderma
Johns Hopkins UniversityLead Sponsor
2,339 Previous Clinical Trials
14,881,741 Total Patients Enrolled
9 Trials studying Scleroderma
497 Patients Enrolled for Scleroderma
Stephen Mathai, MDPrincipal InvestigatorJohns Hopkins University

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT04797286 — Phase 2
Scleroderma Research Study Groups: Sildenafil, Placebo
Scleroderma Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT04797286 — Phase 2
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT04797286 — Phase 2
~5 spots leftby Sep 2025
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