Psoriasis VulgarisPhase 1NCT03675542
The Safety and Efficacy of a Novel HSP90 Inhibitor (CUDC-305) in the Treatment of Moderate to Severe Psoriasis.
A Phase 1 study testing CUDC-305 in people with Psoriasis Vulgaris, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
This is a 12-week treatment, singlecenter, open-label, single-arm, dose-selection, proof of concept study to determine a dosage of HSP 90 inhibitor (CUDC-305) that is tolerable and demonstrates preliminary efficacy for use in future efficacy Phase 2 trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- CUDC-305
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2018to 1 Feb 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged 18 years or older at the time of consent.
- Subject has a history of plaque psoriasis for at least 6 months prior to the screening visit.
- Subject has stable psoriasis conditions for at least 3 months before screening, according to subject.
- Subject has plaque psoriasis covering ≥3% of his total BSA at baseline (Day 0).
- Subject has a PASI score of ≥6 at baseline (Day 0).
- Subject has a PGA score of ≥3 at baseline (Day 0).
Show all 16Show fewer
- Subject has a body mass index (BMI) ≤40 kg/m2.
- Subject is a candidate for phototherapy or systemic treatement of psoriasis (either naïve or has a history of previous treatment).
- 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: Women of nonchildbearing potential are as follows:
- 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 nonchildbearing potential (FSH ≥40 mIU/mL) or cessation of menses for at least 24 months without FSH levels confirmed
- 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. Subject 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 greater than or equal to 5 mm of induration or positive Quantiferon Gold or T-spot test, irrespective of Bacillus Calmette-Guérin (BCG) vaccination status and negative chest x ray 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 evidence of erythrodermic, pustular, predominantly guttate psoriasis, or drug induced psoriasis.
- Subject has a history of skin disease or presence of 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 surgery planned during the study.
Show all 24Show fewer
- Subject has any clinically significant medical condition 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.
- 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 history of clinically significant anemia or hemoglobin (Hgb) value ≤ 10 g/dL at screening.
- Subject has a creatinine 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 CUDC-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 visit (Day 0).
- Subject is currently receiving an investigational product or device or has received one within 4 weeks prior to baseline visit (Day 0).
- Subject has used biologics medication 12 weeks prior to baseline visit (Day 0), or 5 half lives (whichever is longer).
- Subject has used any systemic treatment for psoriasis (including corticosteroids, oral retinoids, immunosuppressive medication, methotrexate, cyclosporine, or apremilast) within 4 weeks prior to baseline visit (Day 0).
- Subject has used any topical medication to treat psoriasis (including corticosteroids; retinoids; vitamin D analogues, such as calcipotriol; or tar) within 2 weeks prior to baseline visit (Day 0).
- Subject had any UVB phototherapy (including tanning beds) or excimer laser within 2 weeks prior to baseline visit (Day 0).
- Subject had PUVA treatment within 4 weeks prior to baseline visit (Day 0).
- Subject has received a live attenuated vaccine within 4 weeks prior to baseline visit (Day 0) or plan to receive a live attenuated vaccine during the study and up to 1 month after the last study drug administration.Subject had excessive sun exposure within 2 weeks prior to baseline visit (Day 0), or is planning a trip to a sunny climate, or is not willing to minimize natural and artificial sunlight exposure during the study. Use of sunscreen products and protective apparel are recommended for other circumstances when exposure cannot be avoided. Sunscreen must not be applied on the clinic visit days before the visit.
- 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.
- Subject is taking anticoagulant medication, such as heparin, low molecular weight (LMW) heparin, warfarin, antiplatelets (nonsteroidal anti-inflammatory drugs [NSAIDs] and low-dose aspirin that is equal or lower than 81 mg will not be considered antiplatelets), or has a contraindication to skin biopsies.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, 8200
Anne Bregnhøj, PhD, annebreg@rm.dk
About this study
Official title: A Phase 1b, Open-label, Single-arm, Dose-selection, Proof-of-concept Study to Assess the Safety and Efficacy of a Novel HSP90 Inhibitor (CUDC-305) in the Treatment of Moderate to Severe Plaque Psoriasis
This is a 12-week treatment, singlecenter, open-label, single-arm, dose-selection, proof of concept study to determine a dosage of HSP 90 inhibitor (CUDC-305) that is tolerable and demonstrates preliminary efficacy for use in future efficacy Phase 2 trials. Male or female subjects aged 18 years or older with moderate to severe plaque psoriasis will be included in this study.
Objectives are to determine the efficacy, safety and tolerability of CUDC-305 in patients with moderate to severe psoriasis.
- Conditions
- Psoriasis Vulgaris
- Being tested
- CUDC-305
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CUDC-305Drug
Dose-selection treatment with HSP90 inhibitor (CUDU-305)
| Study group | Role | What they receive |
|---|---|---|
| Study medication | Experimental | HSP90 inhibitor (CUDC-305) Receives: Drug: CUDC-305 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Psoriasis Area and Severity Index (PASI) score
Clinical severity score
Measured: Week 12
Secondary outcomes (1)
Incidence of treatment-emergent adverse events (TEAEs)
TEAEs
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start1 Nov 2018
- Primary completion1 Nov 2019 (estimated)
- Study completion1 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Model description
- open-label, singlecenter, single-arm, dose-selection, proof of-concept study
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Bregnhøj, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03675542
- Sponsor's protocol ID
- CUDC305
- Status last verified
- Jul 2019
- First submitted
- 17 Sep 2018
- Last updated
- 11 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Open-label, Single-arm, Dose-selection, Proof-of-concept Study to Assess the Safety and Efficacy of a Novel HSP90 Inhibitor (CUDC-305) in the Treatment of Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT03675542
- Acronym / sponsor ID
- CUDC305
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 1 Feb 2020 (estimated)
- First posted
- 18 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 12-week treatment, singlecenter, open-label, single-arm, dose-selection, proof of concept study to determine a dosage of HSP 90 inhibitor (CUDC-305) that is tolerable and demonstrates preliminary efficacy for use in future efficacy Phase 2 trials. Male or female subjects aged 18 years or older with moderate to severe plaque psoriasis will be included in this study.
Objectives are to determine the efficacy, safety and tolerability of CUDC-305 in patients with moderate to severe psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open-label, singlecenter, single-arm, dose-selection, proof of-concept study
| Arm | Type | Receives |
|---|---|---|
| Study medication | Experimental | Drug: CUDC-305HSP90 inhibitor (CUDC-305) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Men or women aged 18 years or older at the time of consent.
- Subject has a history of plaque psoriasis for at least 6 months prior to the screening visit.
- Subject has stable psoriasis conditions for at least 3 months before screening, according to subject.
- Subject has plaque psoriasis covering ≥3% of his total BSA at baseline (Day 0).
- Subject has a PASI score of ≥6 at baseline (Day 0).
Key exclusion criteria (24 listed)
- Female subject who is breastfeeding, pregnant, or who is planning a pregnancy during the study.
- Subject has evidence of erythrodermic, pustular, predominantly guttate psoriasis, or drug induced psoriasis.
- Subject has a history of skin disease or presence of 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CUDC-305Dose-selection treatment with HSP90 inhibitor (CUDU-305) | Drug | Study medication |
Primary outcome
Change from baseline in Psoriasis Area and Severity Index (PASI) score
Time frame: Week 12
Clinical severity score
1 secondary outcome
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Psoriasis Vulgaris
Active, not recruitingPhase 4
Residual Disease MEMory in PSOriasis Skin During EnstiLAR® and Narrow-band Ultraviolet B Therapy: The MEMPSOLAR Study
Psoriasis Vulgaris, Psoriasis
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingPhase 4
Topical Diacerein in Psoriasis Vulgaris
Psoriasis Vulgaris
Not yet recruiting
Ceramol PSOR Cream as an Adjuvant Treatment in Patients With Mild-to-Moderate Psoriasis Treated With Narrowband UVB Phototherapy (CERAMOL PSOR CREMA)
Psoriasis, Psoriasis; Plaque
RecruitingPhase 1
A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of HRS-4139 in Healthy Participants
Psoriasis Vulgaris
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CUDC-305 in people with Psoriasis Vulgaris, 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 16 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 11 Jul 2019. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne Bregnhøj, MD, PhD (+45 2183 5720, annebreg@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Psoriasis Area and Severity Index (PASI) score (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2019.