Phase 2 Multiple Sclerosis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are able to understand and follow instructions throughout the trial
• People who have signed a written consent form before joining, in line with research guidelines
• People aged 18 or older who have been diagnosed with systemic sclerosis (SSc) — either the limited or diffuse type — according to recognised international diagnostic guidelines (2013 ACR/EULAR criteria)
• People who have at least one active finger ulcer caused by SSc that is 2mm or larger in diameter, involves the deeper skin layer (dermis), and is located at the fingertip or on the inner (palm-side) surface of the finger below the first knuckle — present at both the screening visit and the baseline visit
• People who are either: (a) currently taking oral sildenafil 20mg three times daily and have been on this stable dose for at least 2 weeks before screening, or (b) have not taken any oral PDE5 inhibitor medications (such as sildenafil, tadalafil, vardenafil, or mirodenafil) or certain other related medications (theophylline, dipyridamole) for at least 4 weeks before screening
• People whose physical examination shows no unexpected health findings beyond their SSc diagnosis (confirm with trial site)
• People taking certain other medications for SSc (such as endothelin receptor antagonists, calcium channel blockers, or antiplatelets) who have been on a stable dose of these for at least 2 weeks before screening
• Women who are able to become pregnant and who agree to use a highly effective form of contraception throughout the trial and for at least 7 weeks after the last dose of the trial treatment
• Men whose female partner could become pregnant, and who agree to use adequate contraception as required by local guidelines
• People who have health insurance coverage or meet national research participation requirements in their country

Who may not be able to join:

• People whose finger ulcer has a complication such as an active infection, bone infection, or tissue death (gangrene) at the time of screening or baseline visit
• People with a skin severity score (called modified Rodnan Skin Score) above 35 at screening (confirm with trial site)
• People experiencing severe, hard-to-control pain from their finger ulcers, rated 6 or higher on a 0–10 pain scale, at screening or baseline
• People who have calcium deposits (calcinosis) at or around the specific ulcer being studied, either currently or in the past
• People with serious, unstable complications of SSc that need immediate medical treatment — for example, kidney crisis, or poorly controlled lung, heart, or bowel disease related to SSc
• People who have had or are suspected of having cancer in the past 5 years, with some exceptions such as certain treated skin cancers, pre-cancerous skin lesions, closely monitored prostate cancer, or certain early-stage cervical changes
• People with chronic liver disease of any severity
• People with another significant medical condition that, in the investigator's opinion, could put them at risk, interfere with the trial, or affect their ability to participate — including any condition expected to result in a life expectancy of less than 12 months
• People with low blood pressure (systolic below 95 mmHg or diastolic below 50 mmHg) or a resting heart rate below 50 beats per minute at screening or baseline (one repeat measurement is allowed; very athletic individuals may be assessed differently by the investigator)
• People with clinically significant heart rhythm abnormalities found on an ECG, including a prolonged QT interval (450ms or more for men, 460ms or more for women), or certain irregular heartbeats
• People who have had major surgery within 8 weeks before the screening visit
• People with certain liver enzyme levels (AST or ALT) or bilirubin levels that are significantly above the normal range (confirm with trial site for specific values)
• People with reduced kidney function below a certain level (eGFR of 60 ml/min/1.73m² or lower) (confirm with trial site)
• People with other significant abnormal laboratory results that the investigator believes need further investigation
• People who test positive for HIV antibodies (unless this is already known from their medical history)
• People who test positive for hepatitis B surface antigen (unless already known from their medical history)
• People who test positive for hepatitis C antibodies (unless already known from their medical history)
• People who are currently receiving, have recently received (within 4 weeks), or plan to receive intravenous prostanoid medications during the trial
• People who have taken certain other medications in the weeks before screening, including oral prostanoids (selexipag), nitrate-based medications, or guanylate cyclase stimulators (riociguat)
• People taking PDE5 inhibitors other than sildenafil (such as tadalafil or vardenafil) or certain related medications, unless they meet specific inclusion conditions
• People on steroid or immune-suppressing medications, unless they have been on a stable, unchanged dose for at least 4 weeks before screening as part of their ongoing SSc treatment
• People with known allergies or sensitivities to sildenafil or its ingredients — or who are taking certain medications that interact with sildenafil (such as nitrates, certain antifungals, ritonavir, or riociguat) — particularly for participants already on oral sildenafil
• People who have lost vision in one eye due to a specific condition called non-arteritic anterior ischaemic optic neuropathy (NAION) — applicable to participants on oral sildenafil
• People with a recent history of stroke or heart attack — applicable to participants on oral sildenafil
• People with known allergies to components of the trial treatments or wound dressings used in the trial
• People with a known allergy to local anaesthetics of the amide type
• People currently in another clinical trial, or who finished another clinical trial less than 30 days before screening (or less than 2 months if the previous trial involved related types of medications)
• Women who are pregnant or breastfeeding
• People who, in the investigator's opinion, are unlikely to follow the trial requirements or complete the trial as planned
• People who are close relatives of, or work closely with, the trial investigators or trial centre staff, or who are employed by the trial sponsor
• People who are institutionalised due to a legal or regulatory order
• People who are under legal protection (confirm with trial site regarding what this means in your country)

Important: Always verify eligibility with the trial site directly before applying.