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NCT06645821
Open-label, Investigator-initiated, Single-site Proof of Concept Trial Evaluating EVO101 in Adult Subjects with Mild to Moderate Hidradenitis Suppurativa.
EARLY_PHASE1 trial testing EVO101 in Hidradenitis Suppurativa (HS) in 15 participants. Currently enrolling.
1 March 2025
Quick facts
| Lead sponsor | Virginia Clinical Research, Inc. |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 3 December 2024 |
| Primary completion | 1 March 2025 |
| Estimated completion | 1 May 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- EVO101 — full drug profile →
Conditions studied
- Hidradenitis Suppurativa (HS) — all drugs for Hidradenitis Suppurativa (HS) →
Sponsor
Virginia Clinical Research, Inc.
Who can join
18 and older, any sex, with Hidradenitis Suppurativa (HS). Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
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The efficacy of EVO101 on hidradenitis suppurativa will be evaluated using two parameters: decrease in lesion count and change in patient reported outcomes (PRO)
Time frame: 12 Weeks
The change in the total HS lesion count will be assessed at Week 4, Week 8, and Week 12. The percent change from Baseline will be calculated. -
The efficacy of EVO101 on hidradenitis suppurativa will be evaluated using two parameters: decrease in lesion count and change in patient reported outcomes (PRO)
Time frame: 12 Weeks
PRO's will be completed to evaluate whether the subjects perceive a change in their HS symptoms. PRO's will include the DLQI, NRS Scale of Pain, and Patient Impression of Severity. Efficacy will be calculated by the percent change in each PRO from Baseline at Week 4, Week 8, and Week 12.
Sponsor's own description
The goal of this clinical trial is to learn if drug EVO101 works to treat mild to moderate hidradenitis suppurativa in adults. The main questions it aims to answer are: Does drug EVO101 lower the total number of lesion a participant has from the first visit to the last visit. What medical problems do participants have when applying drug EVO101 Does a participant perceive a change in their hidradenitis suppurativa symptoms based on patient reported outcome questionnaires. Participants will: Apply EVO101 topical cream 0.1% topically Visit the clinic four times unless the first and second appointment have to be done separately then there will be five clinic visits and one phone call over a twelve week period. Keep a dosing diary
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06645821
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of EVO101
Trials testing the same drug.
- NCT05579899 — Safety and Efficacy Study of EVO101 Topical Cream in Atopic Dermatitis · Phase 2 · completed
Other recruiting trials for Hidradenitis Suppurativa (HS)
Currently open trials in the same condition.
- NCT07213973 — Pharmacokinetics, Safety, and Efficacy of Povorcitinib in Adolescent Participants With Moderate to Severe Hidradenitis S · Phase 2 · recruiting
- NCT07287644 — A Study Evaluating BFB759 in Moderate to Severe Hidradenitis Suppurativa · Phase 2, PHASE3 · recruiting
- NCT07155239 — 1726-nm Laser for Acne Inversa (Hidradenitis Suppurativa) · Phase 1 · recruiting
- NCT07021495 — SKIN Disease Profiling by an Exploratory, pRospective, Biomarker Study in dermatoloGY Practice (SKINERGY) · recruiting
- NCT07109765 — Secukinumab Treatment for Moderate to Severe Hidradenitis Suppurativa · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06645821 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Virginia Clinical Research, Inc.
- Last refreshed: 5 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06645821.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing