Mild to Moderate PsoriasisPhase 3AKVANO-AKP02NCT05249972
A Phase III Study in Subjects With Mild to Moderate Psoriasis.
A Phase 3 study testing AKP02/AKVANO cutaneous spray (calcipotriol 50 μg/g + betamethasone 0.5 mg/g/ AKVANO) and Enstilar Topical Product (calcipotriol 50 μg/g + betamethasone 0.5 mg/g) in people with Mild to Moderate Psoriasis, run by Lipidor AB at 1 site in India.
Trial summary
A randomized, assessor blind, parallel group, three arms, active and placebo controlled study with objective to demonstrate therapeutic non-inferiority of AKP02 cutaneous spray (calcipotriol 50 μg/g + betamethasone 0.5 mg/g/ AKVANO) versus Enstilar cutaneous foam (calcipotriol 50 μg/g + betamethasone 0.5 mg/g) in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild to Moderate Psoriasis
- What is being tested?
- AKP02/AKVANO cutaneous spray (calcipotriol 50 μg/g + betamethasone 0.5 mg/g/ AKVANO) and Enstilar Topical Product (calcipotriol 50 μg/g + betamethasone 0.5 mg/g)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 294 participants
- Where
- 1 siteIndia
- Study dates
- 24 Jan 2022to 18 Aug 2022
- Phase
- Phase 3
- 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
- Male or non-pregnant female subjects aged >18 years having either Fitzpatrick skin type I-III or IV-VI at the time of screening.
- A clinical diagnosis of stable (at least 6 months) psoriasis vulgaris on body, or body and scalp, involving 5 to 10% of body surface area (BSA) and PASI ≤10., that does not include the face, axilla and groin areas.
- Mild or moderate Psoriasis on Physician Global Assessment (PGA) score (grade 2 - 3).
- A plaque elevation of at least moderate severity (grade ≥ 3) at the target lesion site. The most severe lesion at Baseline should be identified as the target lesion.
- Subjects must be willing to provide written informed consent.
- Subjects must be willing and able to understand and can comply with study requirements, apply the medication as instructed and be able to complete the study.
- Subject must be in general good health as judged by the Investigator, based on medical history and physical examination.
Who cannot join
- Subject with history of hypersensitivity to betamethasone or calcipotriol or any component of the test or reference product or placebo.
- Current diagnosis of unstable forms of psoriasis in the treatment area including guttate, erythrodermic, exfoliative, or pustular psoriasis.
- Subjects with diagnosis of mild to moderate psoriasis only in the scalp area.
- Other inflammatory skin disease in the treatment area that may confound the evaluation of the psoriasis vulgaris (e.g., atopic dermatitis, contact dermatitis, tinea corporis and seborrheic dermatitis).
- Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the treatment areas, which could interfere with the rating of efficacy parameters.
- Subject with history of psoriasis unresponsive to topical treatments.
Show all 24Show fewer
- Subject with psoriasis lesions predominantly on palms and soles or palmo-plantar area.
- Subjects with the diagnosis pustulosis palmo-plantaris
- Subject in need of systemic treatment
- Ongoing use of other psoriasis treatment including but not limited to topical or systemic corticosteroids, other topical medications (i.e. coal tar), oral or biologic medications for the treatment of psoriasis, and UV therapy.
- Use of oral estrogen therapy, excluding oral contraceptive pills
- Females who are pregnant, nursing, or planning a pregnancy
- Females of childbearing potential who do not agree to utilize an adequate form of contraception.
- Current significant medical problems that, in the discretion of the investigator, would put the subject at significant risk
- Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamics half-lives, if known (whichever is longer)
- Current or past history of hypercalcemia, calcium metabolism disorder, vitamin D toxicity, severe renal insufficiency, or severe hepatic disorders.
- Current immunosuppression
- Use of biologic treatment for psoriasis (e.g., infliximab, adalimumab, alefacept) within six months prior to Baseline.
- Use of: 1) chemotherapy, or 2) radiation therapy, within three months prior to Baseline.
- Use of: 1) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), or 2) oral retinoids, within two months prior to Baseline.
- Use of: 1) systemic steroids, 2) systemic antibiotics, 3) other systemic antipsoriatic treatment, 4) PUVA therapy, 5) UVB therapy, or 6) systemic anti-inflammatory agents, within one month prior to Baseline.
- Use of: 1) topical anti-psoriatic drugs (e.g., salicylic acid, anthralin, coal tar, calcipotriol, tazarotene), 2) topical corticosteroids, or 3) topical retinoids, within 2 weeks prior to Baseline.
- Use of medicated shampoos with possible effect on psoriasis
- Subject with positive serology tests like HIV, HCV \& HBsAg.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Lotus Multispeciality Hospital
Ahmedabad
Dr. Neha Sharma, Dr
About this study
Official title: A Randomized Phase III, Three-parallel Arm, Assessor Blind, Multi-centre Study to Evaluate the Efficacy, Safety and Tolerability of AKP02 Cutaneous Spray Versus Enstilar Cutaneous Foam in Subjects With Mild to Moderate Psoriasis.
A randomized, assessor blind, parallel group, three arms, active and placebo controlled study with objective to demonstrate therapeutic non-inferiority of AKP02 cutaneous spray (calcipotriol 50 μg/g + betamethasone 0.5 mg/g/ AKVANO) versus Enstilar cutaneous foam (calcipotriol 50 μg/g + betamethasone 0.5 mg/g) in subjects with mild to moderate plaque psoriasis.
Read the detailed description
Eligible subjects (in total 294) will be randomized in a 3:3:1 fashion to receive AKP02 cutaneous spray, Enstilar cutaneous foam or the AKVANO vehicle spray, respectively. The randomization will be stratified by skin type (Fitzpatrick skin type I-III and Fitzpatrick skin type IV-VI). At least 25 % of the subjects randomized in the study should belong to Fitzpatrick skin type I-III and at least 25 % to Fitzpatrick skin type IV-VI.
- Conditions
- Mild to Moderate Psoriasis
- Being tested
- AKP02/AKVANO cutaneous spray (calcipotriol 50 μg/g + betamethasone 0.5 mg/g/ AKVANO), Enstilar Topical Product (calcipotriol 50 μg/g + betamethasone 0.5 mg/g), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AKP02/AKVANO cutaneous spray (calcipotriol 50 μg/g + betamethasone 0.5 mg/g/ AKVANO)Drug
Topical cutaneous spray
Enstilar Topical Product (calcipotriol 50 μg/g + betamethasone 0.5 mg/g)Drug
Topical foam
PlaceboOther
Placebo cutaneous spray
| Study group | Role | What they receive |
|---|---|---|
| AKP02 | Experimental | cutaneous spray (calcipotriol 50 μg/g + betamethasone 0.5 mg/g/ AKVANO) Receives: Drug: AKP02/AKVANO cutaneous spray (calcipotriol 50 μg/g + betamethasone 0.5 mg/g/ AKVANO); Drug: Enstilar Topical Product (calcipotriol 50 μg/g + betamethasone 0.5 mg/g); Other: Placebo |
| Enstilar | Active comparator | cutaneous foam (calcipotriol 50 μg/g + betamethasone 0.5 mg/g) Receives: Drug: AKP02/AKVANO cutaneous spray (calcipotriol 50 μg/g + betamethasone 0.5 mg/g/ AKVANO); Drug: Enstilar Topical Product (calcipotriol 50 μg/g + betamethasone 0.5 mg/g); Other: Placebo |
| Placebo | Placebo comparator | cutaneous spray Receives: Drug: AKP02/AKVANO cutaneous spray (calcipotriol 50 μg/g + betamethasone 0.5 mg/g/ AKVANO); Drug: Enstilar Topical Product (calcipotriol 50 μg/g + betamethasone 0.5 mg/g); Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in Psoriasis Area and Severity Index (PASI) score
Percentage change in Psoriasis Area and Severity Index (PASI) score from baseline/randomization to the end of treatment between test product (AKP02 cutaneous spray) and comparator product (Enstilar cutaneous foam). High score is worse
Measured: From baseline/randomization to Week 4 (Day 29±4)
Secondary outcomes (4)
Percentage change in Psoriasis Scalp Severity Index (PSSI) scores
Percentage change in Psoriasis Scalp Severity Index (PSSI) scores from baseline to end of treatment. High score is worse
Measured: From date of randomization until Week 4 (Day 29±4) post-randomization
Change in Physician's global assessment (PGA)
Change in Physician's global assessment (PGA) at end of treatment compared to baseline High score is worse
Measured: From date of randomization until Week 4 (Day 29±4) post-randomization
Change in Scalp Physician's global assessment (ScPGA)
Change in Scalp Physician's global assessment (ScPGA) at end of treatment compared to baseline High score is worse
Measured: From date of randomization until Week 4 (Day 29±4) post-randomization
Frequency of adverse events and serious adverse events
Frequency of adverse events and serious adverse events or any event of clinical significance
Measured: From date of randomization until end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start24 Jan 2022
- Primary completion11 Aug 2022 (estimated)
- Study completion18 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate PsoriasisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, assessor blind, parallel group, three arms, active and placebo controlled study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 294 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lipidor AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria Klockare, PhD, Study director, Lipidor AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05249972
- Sponsor's protocol ID
- CRSC20008
- Acronym
- AKVANO-AKP02
- Status last verified
- Aug 2022
- First submitted
- 29 Jan 2022
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A CSR will be provide to all Investigators
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III, Three-parallel Arm, Assessor Blind, Multi-centre Study to Evaluate the Efficacy, Safety and Tolerability of AKP02 Cutaneous Spray Versus Enstilar Cutaneous Foam in Subjects With Mild to Moderate Psoriasis.
- ClinicalTrials.gov ID
- NCT05249972
- Acronym / sponsor ID
- AKVANO-AKP02 / CRSC20008
- Conditions
- Mild to Moderate Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 294 participants (estimated)
- Lead sponsor
- Lipidor ABIndustry (pharma, biotech, devices)
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 11 Aug 2022 (estimated)
- Study completion
- 18 Aug 2022 (estimated)
- First posted
- 22 Feb 2022 (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.
A randomized, assessor blind, parallel group, three arms, active and placebo controlled study with objective to demonstrate therapeutic non-inferiority of AKP02 cutaneous spray (calcipotriol 50 μg/g + betamethasone 0.5 mg/g/ AKVANO) versus Enstilar cutaneous foam (calcipotriol 50 μg/g + betamethasone 0.5 mg/g) in subjects with mild to moderate plaque psoriasis.
Detailed description
Eligible subjects (in total 294) will be randomized in a 3:3:1 fashion to receive AKP02 cutaneous spray, Enstilar cutaneous foam or the AKVANO vehicle spray, respectively. The randomization will be stratified by skin type (Fitzpatrick skin type I-III and Fitzpatrick skin type IV-VI). At least 25 % of the subjects randomized in the study should belong to Fitzpatrick skin type I-III and at least 25 % to Fitzpatrick skin type IV-VI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- A randomized, assessor blind, parallel group, three arms, active and placebo controlled study
| Arm | Type | Receives |
|---|---|---|
| AKP02 | Experimental | Drug: AKP02/AKVANO cutaneous spray (calcipotriol 50 μg/g + betamethasone 0.5 mg/g/ AKVANO), Drug: Enstilar Topical Product (calcipotriol 50 μg/g + betamethasone 0.5 mg/g), Other: Placebocutaneous spray (calcipotriol 50 μg/g + betamethasone 0.5 mg/g/ AKVANO) |
| Enstilar | Active comparator | Drug: AKP02/AKVANO cutaneous spray (calcipotriol 50 μg/g + betamethasone 0.5 mg/g/ AKVANO), Drug: Enstilar Topical Product (calcipotriol 50 μg/g + betamethasone 0.5 mg/g), Other: Placebocutaneous foam (calcipotriol 50 μg/g + betamethasone 0.5 mg/g) |
| Placebo | Placebo comparator | Drug: AKP02/AKVANO cutaneous spray (calcipotriol 50 μg/g + betamethasone 0.5 mg/g/ AKVANO), Drug: Enstilar Topical Product (calcipotriol 50 μg/g + betamethasone 0.5 mg/g), Other: Placebocutaneous spray |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or non-pregnant female subjects aged >18 years having either Fitzpatrick skin type I-III or IV-VI at the time of screening.
- A clinical diagnosis of stable (at least 6 months) psoriasis vulgaris on body, or body and scalp, involving 5 to 10% of body surface area (BSA) and PASI ≤10., that does not include the face, axilla and groin areas.
- Mild or moderate Psoriasis on Physician Global Assessment (PGA) score (grade 2 - 3).
- A plaque elevation of at least moderate severity (grade ≥ 3) at the target lesion site. The most severe lesion at Baseline should be identified as the target lesion.
- Subjects must be willing to provide written informed consent.
Key exclusion criteria (24 listed)
- Subject with history of hypersensitivity to betamethasone or calcipotriol or any component of the test or reference product or placebo.
- Current diagnosis of unstable forms of psoriasis in the treatment area including guttate, erythrodermic, exfoliative, or pustular psoriasis.
- Subjects with diagnosis of mild to moderate psoriasis only in the scalp area.
- Other inflammatory skin disease in the treatment area that may confound the evaluation of the psoriasis vulgaris (e.g., atopic dermatitis, contact dermatitis, tinea corporis and seborrheic dermatitis).
- Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the treatment areas, which could interfere with the rating of efficacy parameters.
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 |
|---|---|---|
| AKP02/AKVANO cutaneous spray (calcipotriol 50 μg/g + betamethasone 0.5 mg/g/ AKVANO)Topical cutaneous spray | Drug | AKP02, Enstilar, Placebo |
| Enstilar Topical Product (calcipotriol 50 μg/g + betamethasone 0.5 mg/g)Topical foam | Drug | AKP02, Enstilar, Placebo |
| PlaceboPlacebo cutaneous spray | Other | AKP02, Enstilar, Placebo |
Primary outcome
Percentage change in Psoriasis Area and Severity Index (PASI) score
Time frame: From baseline/randomization to Week 4 (Day 29±4)
Percentage change in Psoriasis Area and Severity Index (PASI) score from baseline/randomization to the end of treatment between test product (AKP02 cutaneous spray) and comparator product (Enstilar cutaneous foam). High score is worse
4 secondary outcomes
Percentage change in Psoriasis Scalp Severity Index (PSSI) scores
Time frame: From date of randomization until Week 4 (Day 29±4) post-randomization
Change in Physician's global assessment (PGA)
Time frame: From date of randomization until Week 4 (Day 29±4) post-randomization
Change in Scalp Physician's global assessment (ScPGA)
Time frame: From date of randomization until Week 4 (Day 29±4) post-randomization
Frequency of adverse events and serious adverse events
Time frame: From date of randomization until end of study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Individual participant dataSharing planned: No. A CSR will be provide to all Investigators
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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.
Maria Klockare, PhD study director
Lipidor AB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AKP02/AKVANO cutaneous spray (calcipotriol 50 μg/g + betamethasone 0.5 mg/g/ AKVANO) and Enstilar Topical Product (calcipotriol 50 μg/g + betamethasone 0.5 mg/g) in people with Mild to Moderate Psoriasis, run by Lipidor AB at 1 site in India.
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 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 10 Aug 2022. 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 India. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Maria Klockare (+46706232505, maria.klockare@lipidor.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in Psoriasis Area and Severity Index (PASI) score (time frame: From baseline/randomization to Week 4 (Day 29±4)). 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 10 Aug 2022.