Mild-to-moderate Psoriasis VulgarisPhase 1/22011-00500-15NCT01595997
Intra-dermal Injections of DLX105 Into Lesional Skin in Patients With Mild-to-moderate Psoriasis Vulgaris
A Phase 1/2 study testing DLX105 in people with Mild-to-moderate Psoriasis Vulgaris, run by Delenex Therapeutics AG at 2 sites in 2 countries.
Trial summary
The overall purpose of this study is to support the development of a DLX105 topical formulation for the indication mild to moderate psoriasis vulgaris. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mild-to-moderate Psoriasis Vulgaris
- What is being tested?
- DLX105
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Feb 2012to Oct 2012
- Phase
- Phase 1/2
- 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
- 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 pronounced but not active lesions of >9 cm2 each, stable for at least 3 months, local PASI score ≥8. Distance between lesions must be at least 30 cm.
- Affected body surface area (BSA) ≤10%
- Negative pregnancy test for females of child bearing potential (pre-menopausal, <2 years post-menopausal, not surgically sterile)
Who cannot join
- Forms of psoriasis other than chronic plaque-type (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 psoriasis treatments (duration of washout, i.e. discontinuation prior to randomization):
- Alefacept (6 months)
- Biological agents other than alefacept, e.g. adalimumab, efalizumab, etanercept, infliximab, ustekinumab (12 weeks)
- Systemic therapy for psoriasis and psoriatic arthritis (other than above) e.g. methotrexate, cyclosporin, fumaric acid (derivatives), systemic steroids (4 weeks)
Show all 35Show fewer
- Photochemotherapy e.g., ultraviolet A with psoralen (PUVA) (4 weeks)
- Phototherapy e.g., ultraviolet A (UVA) or ultraviolet B (UVB) (2 weeks)
- Topical treatments, except in face, scalp and genital area during screening (2 weeks)
- Other investigational psoriasis drugs (4 weeks or 5 half-lives, whichever is longer)
- Ongoing use of other (non-psoriasis) treatments (duration of washout, i.e. discontinuation prior to randomization):
- Investigational drugs, not psoriasis drugs (4 weeks or 5 half-lives, whichever is longer)
- Known immunosuppression
- 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 keratoses, 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 baseline
- Active liver disease with alanine aminotransferase (ALT) and / or aspartate aminotransferase (AST) > 3 x upper limit of normal
- 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 drug or to excipients of similar chemical classes
- History of hypersensitivity to any active ingredient of similar chemical entity (polypeptides)
- 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 or other means
- 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 some 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 12 weeks after the last study drug administration
- Participation in any other clinical trial within 4 weeks prior to or during this trial
- Exposure to DLX105 / ESBA105 in previous studies of this antibody fragment or in Part A of this study (i.e. the same patient cannot participate in Part A and B)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Multi-center, Double-blinded, Randomized, Placebo-controlled, Intra-individual Comparison, Phase Ib Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Intra-dermal Injections of DLX105 Into Lesional Skin in Patients With Mild-to-moderate Psoriasis Vulgaris
The overall purpose of this study is to support the development of a DLX105 topical formulation for the indication mild to moderate psoriasis vulgaris.
- Conditions
- Mild-to-moderate Psoriasis Vulgaris
- Being tested
- DLX105
- Keywords
- safety tolerability and immunogenicity of two different doses of DLX105 applied intra-dermally into psoriatic lesion of mild-to-moderate psoriatic patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DLX105Drug
intradermal injections (volume: 0.1 mL) of 0.02 mg (low dose cohort), 1 mg (high dose cohort) DLX105, days: Day 1, Day 4, Day 7 and Day 10
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: DLX105 |
| DLX105 | Experimental | Not described Receives: Drug: DLX105 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local tolerability: Investigator's assessment of local tolerability using a validated score for each treatment area. Patient's assessment of subjective tolerability sensations (burning, itching, pain) recorded on a visual analogue scale (VAS) (0-10
Measured: 28 days
Secondary outcomes (2)
Safety variables:
Adverse events Detection of anti-drug antibodies (ADAs). Assessment of immunogenic potential of DLX105 by ELISA with coated DLX105 to capture anti-DLX105 antibodies
Measured: 28 days
Efficacy variables
clinical signs of pharmacodynamic activity to intra-dermal administration of DLX105
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study startFeb 2012
- Primary completionAug 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild-to-moderate 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Delenex Therapeutics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01595997
- Sponsor's protocol ID
- DLX105-003-001-001
- Acronym
- 2011-00500-15
- Status last verified
- Jan 2013
- First submitted
- 9 May 2012
- Last updated
- 8 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Double-blinded, Randomized, Placebo-controlled, Intra-individual Comparison, Phase Ib Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Intra-dermal Injections of DLX105 Into Lesional Skin in Patients With Mild-to-moderate Psoriasis Vulgaris
- ClinicalTrials.gov ID
- NCT01595997
- Acronym / sponsor ID
- 2011-00500-15 / DLX105-003-001-001
- Conditions
- Mild-to-moderate Psoriasis Vulgaris
- Keywords
- safety tolerability and immunogenicity of two different doses of DLX105 applied intra-dermally into psoriatic lesion of mild-to-moderate psoriatic patients
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Delenex Therapeutics AGIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 10 May 2012 (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.
The overall purpose of this study is to support the development of a DLX105 topical formulation for the indication mild to moderate psoriasis vulgaris.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: DLX105 |
| DLX105 | Experimental | Drug: DLX105 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed and dated Informed Consent
- 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 pronounced but not active lesions of >9 cm2 each, stable for at least 3 months, local PASI score ≥8. Distance between lesions must be at least 30 cm.
- Affected body surface area (BSA) ≤10%
- Negative pregnancy test for females of child bearing potential (pre-menopausal, <2 years post-menopausal, not surgically sterile)
Key exclusion criteria (35 listed)
- Forms of psoriasis other than chronic plaque-type (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 psoriasis treatments (duration of washout, i.e. discontinuation prior to randomization):
- Alefacept (6 months)
- Biological agents other than alefacept, e.g. adalimumab, efalizumab, etanercept, infliximab, ustekinumab (12 weeks)
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 |
|---|---|---|
| DLX105intradermal injections (volume: 0.1 mL) of 0.02 mg (low dose cohort), 1 mg (high dose cohort) DLX105, days: Day 1, Day 4, Day 7 and Day 10 | Drug | DLX105, Placebo |
Primary outcome
Local tolerability: Investigator's assessment of local tolerability using a validated score for each treatment area. Patient's assessment of subjective tolerability sensations (burning, itching, pain) recorded on a visual analogue scale (VAS) (0-10
Time frame: 28 days
2 secondary outcomes
Safety variables:
Time frame: 28 days
Efficacy variables
Time frame: 28 days
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 8 Jan 2013.
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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DLX105 in people with Mild-to-moderate Psoriasis Vulgaris, run by Delenex Therapeutics AG at 2 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 4 inclusion and 35 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 8 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, Germany. 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 combined 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.
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?
Local tolerability: Investigator's assessment of local tolerability using a validated score for each treatment area. Patient's assessment of subjective tolerability sensations (burning, itching, pain) recorded on a visual analogue scale (VAS) (0-10 (time frame: 28 days). 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 8 Jan 2013; AzTrials last refreshed its copy on 8 Nov 2026.