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Hidradenitis SuppurativaPhase 1NCT05286567

A Double-blind Placebo-controlled Randomized Trial Evaluating the Efficacy and Safety of a Novel HSP90 Inhibitor (RGRN-305) in the Treatment of Moderate to Severe Hidradenitis Supppurativa.

A Phase 1 study testing RGRN-305 in people with Hidradenitis Suppurativa, run by Aarhus University Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a 16-week treatment, randomized, double-blind, proof-of-concept study designed to assess the safety and efficacy of RGRN-305 compared to placebo for use in future efficacy Phase 2 trials. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Hidradenitis Suppurativa
What is being tested?
RGRN-305
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
15 participants
Where
1 siteDenmark
Study dates
1 Sep 2021to 29 Aug 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects will be eligible to be enrolled in the study if they meet all of the following criteria at the Screening and Baseline (Day 0) Visits, unless specified otherwise:
  • Men or women aged 18 years or older at the time of consent.
  • Subject has a history of onset of hidradenitis suppurativa for at least 6 months prior to Baseline (Day 0) Visit.
  • Subject has hidradenitis suppurativa with at least 5 inflammatory nodules or abscesses (total AN count) in at least 2 distinct anatomic areas, both at Screening and Baseline (Day 0) Visits. Furthermore, one additional inflammatory nodule must be present for collection of skin biopsies.
  • Subjects (women and men) involved in any sexual intercourse that could lead to pregnancy must agree to use an effective contraceptive method from at least 4 weeks before Baseline (Day 0) until at least 4 weeks after the last study product administration for the duration of the study. Effective contraceptive methods are: systemic hormonal contraceptives (oral contraceptive, patch, vaginal ring, injectables, or implants), intrauterine devices, vasectomy, or barrier methods of contraception in conjunction with spermicide. Hormonal contraceptives must be on a stable dose for at least 4 weeks before Baseline (Day 0).
  • Note: Woman of non-childbearing potential are as follows:
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  • Women who have had surgical sterilization (hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation).
  • Women ≥ 60 years of age.
  • Women > 40 and < 60 years of age who have had a cessation of menses for at least 12 months and a follicle-stimulating hormone (FSH) test confirming non-childbearing potential (FSH ≥ 40 mIU/mL) or cessation of menses for at least 24 months without FSH levels confirmed.
  • Protocol RGRN-305 - Safety and Efficacy of RGRN-305 in HS Page 13 of 61 Protocol version 3.2: 13 September 2021
  • Women of childbearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test at Baseline (Day 0).
  • Subject must have negative tuberculosis (TB) infection tests. Subjects will be evaluated for latent TB infection with a purified protein derivative (PPD) test, T-spot test or a Quantiferon Gold test, and with a chest x-ray, if one has not been performed in the last 6 months. Subject who demonstrates evidence of latent TB infection (either PPD ≥ 5 mm of induration or positive Quantiferon Gold or T-spot test, irrespective of Bacillus Calmette-Guérin (BCG) vaccination status and negative chest x-rays findings for active TB, or suspicious chest x-ray findings) will not be allowed to participate in the study.
  • Subject must be willing to participate and must be capable of giving informed consent, and the consent must be obtained prior to any study-related procedures.

Who cannot join

  • Female subject who is breastfeeding, pregnant, or who is planning a pregnancy during the study.
  • Subject has a history of skin disease or presence of a skin condition that, in the opinion of the investigator, would interfere with the study assessments.
  • Subject is known to have immune deficiency or is immunocompromised.
  • Subject has a history of cancer or lymphoproliferative disease within 5 years prior to Baseline (Day 0). Subjects with successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix are not to be excluded.
  • Subject has had a major surgery within 8 weeks prior to Baseline (Day 0) or has a major surgery planned during the study.
  • Subject has any clinically significant medical condition including ongoing infections, or physical/laboratory/ECG/vital signs abnormality that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results.
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  • Subject has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values ≥ 2 times the upper limit of normal (ULN) at Screening.
  • Subject has absolute neutrophil count ≤ 1.5 X 109/L or platelet count ≤ 100 X 109/L at Screening.
  • Subject has a history of clinically significant anemia or hemoglobin (Hgb) value ≤ 10 g/dL (6.21 mmol/dL) at Screening.
  • Subject has a creatine clearance ≤ 60 mL/min at Screening (calculated with Cockcroft-Gault formula).
  • Subject with positive results for hepatitis B surface antigens (HBsAg), anti-hepatitis B core antibodies (anti-HBc), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
  • Subject has a known or suspected allergy to RGRN-305 or any component of the investigational product.
  • Subject has a history of clinically significant drug or alcohol abuse in the last year prior to Baseline (Day 0) Visit.
  • Subject is currently receiving an investigational product or device or has received one within 4 weeks prior to Baseline (Day 0) Visit.
  • Subject has received a live attenuated vaccine within 4 weeks prior to Baseline (Day 0) Visit or plan to receive a live attenuated vaccine during the study and up to 1 month after the last study drug administration.
  • Subject has a history of an allergic reaction or significant sensitivity to lidocaine or other local anesthetics.
  • Subject has a history of hypertrophic scarring or keloid formation in scars or suture sites.
  • Known inability or unavailability of a subject to complete required study visits during study participation.
  • A psychiatric condition (e.g., suicidal ideation), chronic alcohol, or drug abuse problem, determined from the subject's medical history, which, in the opinion of the investigator, may pose a threat to subject compliance.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Aarhus University Hospital

    Aarhus, 8200

Other trials in Denmark

About this study

Official title: An Investigator Initiated, Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Proof-Of-Concept Study to Assess the Safety and Efficacy of a Novel HSP90 Inhibitor (RGRN-305) in the Treatment of Moderate to Severe Hidradenitis Suppurativa

This is a 16-week treatment, randomized, double-blind, proof-of-concept study designed to assess the safety and efficacy of RGRN-305 compared to placebo for use in future efficacy Phase 2 trials.

Male or female subjects aged 18 years or older with moderate to severe hidradenitis suppurativa will be included in this study.

Objectives are to determine the efficacy and safety of RGRN-305 in patients with moderate to severe hidradenitis supppurativa.

Being tested
RGRN-305, Placebo
Medical subject headings
Hidradenitis Suppurativa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RGRN-305Drug

    Heat shock protein 90 inhibitor

  • PlaceboDrug

    Placebo (blinded)

Study groups in NCT05286567
Study groupRoleWhat they receive
RGRN-305Experimental1 tablet of 250mg RGRN-305 once daily for 16 weeks
Receives: Drug: RGRN-305
PlaceboPlacebo comparator1 tablet of placebo once daily for 16 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of subjects achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR-50) score

    Measured: Week 16

Secondary outcomes (9)

  1. Percentage of subjects with Hidradenitis Suppurativa Physician's Global Assessment (HS-PGA) scores of clear or minimal

    Measured: Week 2, 4, 8, 12, 14, 16, and 20.

  2. Percentage of subjects achieving HiSCR-50, HiSCR-75, and HiSCR-90

    Measured: Week 2, 4, 8, 12, 14, 16, and 20.

  3. Changes from Baseline in the Dermatology Life Quality Index (DLQI) total score

    Minimum score: 0 (no effect at all on patient's life) Maximum score: 30 (extremely large effect on patient's life)

    Measured: Week 4, 8, 12, 16, and 20.

  4. Changes from Baseline in the Pain Numerical Ranging score

    Minimum score: 0 (No pain) Maximum score: 10 (worst pain)

    Measured: Weeks 4, 8, 12, 16, and 20

  5. Change and percent change from Baseline in lesion counts (abscess count, inflammatory nodule count, AN count, and draining tunnel count).

    Measured: Week 2, 4, 8, 12, 14, 16, and 20.

  6. Change from Baseline in skin biomarkers

    Measured: Week 16.

  7. Change from Baseline in blood biomarkers

    Measured: Week 4, 8, 12, and 16.

  8. Incidence of treatment-emergent adverse events (TEAEs).

    Measured: Week 20

  9. Incidence of related TEAEs.

    Measured: Week 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2022
  2. Study start1 Sep 2021
  3. Primary completion29 Aug 2022
  4. Study completion29 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05286567
Sponsor's protocol ID
RGRN-305-002
Other IDs
2021-000881-13
Status last verified
Jan 2023
First submitted
10 Mar 2022
Last updated
31 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Ben Abdallah H, Bregnhoj A, Emmanuel T, Ghatnekar G, Johansen C, Iversen L. Efficacy and Safety of the Heat Shock Protein 90 Inhibitor RGRN-305 in Hidradenitis Suppurativa: A Parallel-Design Double-Blind Trial. JAMA Dermatol. 2024 Jan 1;160(1):63-70. doi: 10.1001/jamadermatol.2023.4800.

    PubMed 38055242

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RGRN-305 in people with Hidradenitis Suppurativa, run by Aarhus University Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of subjects achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR-50) score (time frame: Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05286567, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.

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