Psoriasis VulgarisPhase 2NCT01936337
Topical Double-blind, Randomized, Placebo-controlled Study in Psoriasis Patients
A Phase 2 study testing DLX105 Hydrogel in people with Psoriasis Vulgaris, run by Delenex Therapeutics AG at 3 sites in 2 countries.
Trial summary
In this study, the safety, tolerability and efficacy of DLX105 administered topically onto the psoriatic lesion of mild-to-moderate psoriasis patients will be investigated. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- DLX105 Hydrogel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Aug 2013to Jul 2014
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent prior to initiation of any study procedures.
- Male or female Caucasian aged 18-75 years.
- Male or female patients with stable chronic mild-to-moderate plaque-type psoriasis (PASI ≤15).
- Male or female Caucasian patients with stable chronic mild-to-moderate plaque-type psoriasis (PASI ≤15) aged 18-75 years who must have at least two psoriasis lesions of >9 cm2 (located at arms and/or trunk, excluding elbows and legs), stable for at least 3 months, local PASI score ≥8.
- Affected body surface area (BSA) ≤10%.
- Negative pregnancy test for females of child-bearing potential (pre-menopausal, <2 years post-menopausal, not surgically sterile).
- Willing and able to participate in the trial as an outpatient and comply with all trial requirements.
Who cannot join
- Forms of psoriasis other than chronic plaque-type only (e.g., pustular, erythrodermic and guttate psoriasis, palmar, plantar or nail disease) at screening.
- Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) prior to randomization
- Ongoing use of prohibited psoriasis treatments (duration of washout, i.e. discontinuation prior to randomization):
- Biological agents, e.g. adalimumab, etanercept, infliximab, ustekinumab, alefacept (12 weeks)
- Systemic therapy for psoriasis and psoriatic arthritis (other than above) e.g. methotrexate, cyclosporin, fumaric acid (derivatives), systemic steroids (4 weeks)
- Photochemotherapy e.g., ultraviolet A with psoralen (PUVA) (4 weeks)
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- Phototherapy e.g., ultraviolet A (UVA) or ultraviolet B (UVB) (2 weeks)
- Topical therapies for the treatment of Ps such as corticosteroids, vitamin D analogues or retinoids within 14 days prior to baseline
- Other investigational psoriasis drugs (4 weeks or 5 half-lives, whichever is longer)
- Intake of any investigational drug or participation in a Clinical Trial within 4 weeks or 5 half-lives, (whichever is longer) prior to baseline.
- History or evidence of active tuberculosis. All patients will be tested for tuberculosis status using a blood test (QuantiFERON TB-Gold) unless this test has been performed within 4 months prior to randomization and was negative. Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment has been initiated according to local regulations.
- Active systemic infections (other than common cold) during the two weeks before randomization
- Positive test for hepatitis B or C at screening
- Positive test for HIV at screening
- History or symptoms of malignancy of any organ system (other than history of basal cell carcinoma and / or up to three squamous cell carcinomas of the skin, if successful treatment has been performed, with no signs of recurrence; actinic keratosis, if present at screening, should be treated according to standard therapy before randomization), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- History of severe hypersensitivity to any human or humanized biological agents
- Any severe, progressive or uncontrolled medical condition at baseline that in the judgment of the investigator prevents the patient from participating in the study.
- Any clinically significant abnormal laboratory tests at screening
- Active liver disease with alanine aminotransferase (ALT) and / or aspartate aminotransferase (AST) > 3 x upper limit of normal at screening
- History of moderate or severe congestive heart failure (New York Heart Association [NYHA] class III or IV)
- Inability or unwillingness to undergo repeated venipunctures (e.g., due to poor tolerability or lack of access to veins)
- History or evidence of drug or alcohol abuse within the 6 months prior first study drug administration
- Patients who had live vaccination within 6 weeks prior first study drug administration, or will require live vaccination during the course of the trial
- History of hypersensitivity to any of the excipients of the study drugs or to excipients of similar chemical classes
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (HCG) laboratory test (> 5 mIU/mL)
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant. UNLESS they are women whose partners have been sterilized by vasectomy
- Using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, condoms (by the partner), and intrauterine devices (IUDs)). Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not considered acceptable forms of birth control within this study
- Reliable contraception should be maintained throughout the study and for 2 weeks after the last study drug administration
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
Official title: A Multi-center, Double-blinded, Randomized, Placebo-controlled, Phase II Study to Evaluate the Safety, Tolerability and Efficacy of a Topical Application of DLX105 Onto Lesional Skin in Patients With Mild-to-moderate Psoriasis Vulgaris
In this study, the safety, tolerability and efficacy of DLX105 administered topically onto the psoriatic lesion of mild-to-moderate psoriasis patients will be investigated.
- Conditions
- Psoriasis Vulgaris
- Being tested
- DLX105 Hydrogel, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DLX105 HydrogelDrug
topical administration on psoriatic plaque
PlaceboDrug
topical administration on psoriatic plaque
| Study group | Role | What they receive |
|---|---|---|
| DLX105 Hydrogel | Active comparator | Not described Receives: Drug: DLX105 Hydrogel |
| Placebo Hydrogel | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of local tolerability by the investigator
using a validated score for each treatment area
Measured: up to 6 weeks
assessment of local tolerability sensations by the patient
using a visual analogue scale for each treatment area
Measured: up to 6 weeks
collection of Adverse Events
Measured: up to 6 weeks
Determination of efficacy of DLX105 as compared to baseline
assessment of Local PASI score per plaque measured at week 4 compared to baseline
Measured: Baseline to Week 4
Determination of efficacy of DLX105 as compared to Placebo at week 4
Local PASI difference at week 4 between DLX105 and placebo
Measured: baseline to week 4
Secondary outcomes (2)
Detection of Immunogenicity
Anti-drug-antibodies will be determined to assess the immunogenic potential of DLX105.
Measured: up to 6 weeks
Detection of Pharmacokinetics
Pharmacokinetics through levels will be measured in serum at 4 time points over 6 weeks.
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionJun 2014
- Study completionJul 2014
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delenex Therapeutics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01936337
- Sponsor's protocol ID
- DLX105-003-002-001
- Status last verified
- Aug 2014
- First submitted
- 28 Aug 2013
- Last updated
- 12 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Double-blinded, Randomized, Placebo-controlled, Phase II Study to Evaluate the Safety, Tolerability and Efficacy of a Topical Application of DLX105 Onto Lesional Skin in Patients With Mild-to-moderate Psoriasis Vulgaris
- ClinicalTrials.gov ID
- NCT01936337
- Acronym / sponsor ID
- DLX105-003-002-001
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Delenex Therapeutics AGIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 6 Sep 2013 (estimated)
- 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.
In this study, the safety, tolerability and efficacy of DLX105 administered topically onto the psoriatic lesion of mild-to-moderate psoriasis patients will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DLX105 Hydrogel | Active comparator | Drug: DLX105 Hydrogel |
| Placebo Hydrogel | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed and dated informed consent prior to initiation of any study procedures.
- Male or female Caucasian aged 18-75 years.
- Male or female patients with stable chronic mild-to-moderate plaque-type psoriasis (PASI ≤15).
- Male or female Caucasian patients with stable chronic mild-to-moderate plaque-type psoriasis (PASI ≤15) aged 18-75 years who must have at least two psoriasis lesions of >9 cm2 (located at arms and/or trunk, excluding elbows and legs), stable for at least 3 months, local PASI score ≥8.
- Affected body surface area (BSA) ≤10%.
Key exclusion criteria (28 listed)
- Forms of psoriasis other than chronic plaque-type only (e.g., pustular, erythrodermic and guttate psoriasis, palmar, plantar or nail disease) at screening.
- Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) prior to randomization
- Ongoing use of prohibited psoriasis treatments (duration of washout, i.e. discontinuation prior to randomization):
- Intake of any investigational drug or participation in a Clinical Trial within 4 weeks or 5 half-lives, (whichever is longer) prior to baseline.
- History or evidence of active tuberculosis. All patients will be tested for tuberculosis status using a blood test (QuantiFERON TB-Gold) unless this test has been performed within 4 months prior to randomization and was negative. Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment has been initiated according to local regulations.
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 |
|---|---|---|
| DLX105 Hydrogeltopical administration on psoriatic plaque | Drug | DLX105 Hydrogel |
| Placebotopical administration on psoriatic plaque | Drug | Placebo Hydrogel |
Primary outcome
Assessment of local tolerability by the investigator
Time frame: up to 6 weeks
using a validated score for each treatment area
assessment of local tolerability sensations by the patient
Time frame: up to 6 weeks
using a visual analogue scale for each treatment area
collection of Adverse Events
Time frame: up to 6 weeks
Determination of efficacy of DLX105 as compared to baseline
Time frame: Baseline to Week 4
assessment of Local PASI score per plaque measured at week 4 compared to baseline
Determination of efficacy of DLX105 as compared to Placebo at week 4
Time frame: baseline to week 4
Local PASI difference at week 4 between DLX105 and placebo
2 secondary outcomes
Detection of Immunogenicity
Time frame: up to 6 weeks
Detection of Pharmacokinetics
Time frame: up to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DLX105 Hydrogel in people with Psoriasis Vulgaris, run by Delenex Therapeutics AG at 3 sites in 2 countries.
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 7 inclusion and 28 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 12 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Austria. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Assessment of local tolerability by the investigator (time frame: up to 6 weeks). The study lists 5 primary outcomes in all. 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 12 Aug 2014.