Palmoplantaris PustulosisPhase 2NCT04057937
A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Japanese Subjects With Palmoplantar Pustulosis
A Phase 2 study testing Apremilast in people with Palmoplantaris Pustulosis, run by Amgen at 22 sites in Japan.
Trial summary
This study will evaluate whether apremilast is better than placebo (inactive substance in the same form as the drug) for the treatment in Japanese subjects with PPP. This study also will evaluate the safety and tolerability of apremilast in Japanese subjects with PPP.CC-10004-PPP-001 is a multicenter, randomized… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Palmoplantaris Pustulosis
- What is being tested?
- Apremilast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 22 sitesJapan
- Study dates
- 16 Oct 2019to 7 Jun 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must satisfy the following criteria to be enrolled in the study:
- Subject has a diagnosis of Palmoplantar Pustulosis with or without pustulotic arthro-osteitis (PAO) for at least 24 weeks before screening.
- Subject has a total score of PPPASI: ≥ 12 at screening and baseline.
- Subject has moderate or severe pustules/vesicles on palms or soles (PPPASI severity score: ≥ 2) at screening and baseline.
- Subject has inadequate response to treatment with topical steroid and/or topical vitamin D3 derivative preparations prior to or at screening.
Who cannot join
- The presence of any of the following will exclude a subject from enrollment:
- Subject has a diagnosis of plaque-type psoriasis.
- Subject has the presence of pustular psoriasis in any part of the body other than the palms and soles.
- Subject has obvious improvement during screening (≥ 5 PPPASI total score improvement during the screening).
- Subject has received any procedures for focal infection (e.g, tonsillectomy and dental therapy) within 24 weeks of baseline.
- Subject has periodontitis obviously requiring treatment at screening.
Show all 9Show fewer
- Subject has chronic or recurrent tonsillitis or sinusitis requiring any continuous treatment for a month or more at screening.
- Subject has evidence of skin conditions of hands and feet that would interfere with evaluations of the effect of study medication.
- Subject is pregnant or breastfeeding.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Japan22 sites
Research Site
Chiyoda-ku, Tokyo, 102-8798
Research Site
Fukuoka, Fukuoka, 814-0180
Research Site
Hitachi, Ibaraki, 317-0077
Research Site
Ichinomiya, Aichi-ken, 491-8558
Research Site
Izumo, Shimane, 693-8501
Research Site
Kisarazu, 292-8535
Research Site
Kofu, 400-0027
Research Site
Minokamo, 505-8503
Research Site
Nagoya, Aichi-ken, 467-8602
Research Site
Nankoku-shi, 783-8505
Research Site
Osaka, 550-0006
Research Site
Sagamihara-shi, Kanagawa, 252-0392
Research Site
Sapporo, Hokkaido, 060-0063
Research Site
Sendai, 980-8574
Research Site
Shinjuku-ku, 161-8521
Research Site
Shinjyuku-ku, 160-0023
Research Site
tabashi City, Tokyo, 173-8606
Research Site
tabashi City, 173-8610
Research Site
Tōon, 791-0295
Research Site
Tsu, 514-8507
Research Site
Yokohoma-shi, Kanagawa, 221-0825
Research Site
Yokosuka, Kanagawa, 238-8558
About this study
Official title: A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Palmoplantar Pustulosis in Japan
This study will evaluate whether apremilast is better than placebo (inactive substance in the same form as the drug) for the treatment in Japanese subjects with PPP. This study also will evaluate the safety and tolerability of apremilast in Japanese subjects with PPP.CC-10004-PPP-001 is a multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase 2 study of apremilast in Japanese subjects with PPP and inadequate response to treatment with topical steroid and/or topical vitamin D3 derivative preparations.
The placebo-controlled period will be 16 weeks and patients will receive apremilast or placebo. After the 16-week placebo-controlled period, all subjects will receive apremilast for 16 weeks. All subjects will have their final study visit 4 weeks after stopping apremilast treatment.
- Conditions
- Palmoplantaris Pustulosis
- Being tested
- Apremilast, Placebo
- Keywords
- Palmoplantar Pustulosis, CC-10004, Apremilast, Only Japanese, Efficacy, Safety, Phase 2
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApremilastDrug
Also called CC-10004
Apremilast
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo then Apremilast 30mg BID | Experimental | Participants received matched placebo as oral tablets twice daily (BID) for up to 16 weeks (Week 0 to Week 16). Participants who completed the placebo-controlled phase entered the active-treatment phase and received apremilast 30 mg as oral tablets BID for up to an additional 16 weeks (Week 16 to Week 32). Receives: Drug: Apremilast; Drug: Placebo |
| Apremilast 30 mg BID then Apremilast 30 mg BID | Experimental | Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16). Participants who completed the placebo-controlled phase entered the active-treatment phase and received apremilast 30 mg as oral tablets BID for up to an additional 16 weeks (Week 16 to Week 32). Receives: Drug: Apremilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Achieve a PPPASI-50 at Week 16
PPPASI-50 is defined as >= 50 percent decrease in PPPASI total score from baseline.
PPPASI is a disease-specific efficacy assessment tool to evaluated for 3 signs of the disease (erythema, pustules/vesicle and desquamation/scale) as sub-scores on palms or soles. The PPPASI total scores are calculated by sum of the sub-scores and range from 0 to 72 with a higher score indicating more severe disease.
Measured: At Week 16
Secondary outcomes (11)
Percentage of Participants Who Achieve a PPPASI-50 at All Other Visits in Placebo-controlled Phase
PPPASI-50 is defined as >= 50 percent decrease in PPPASI total score from baseline.
PPPASI is a disease-specific efficacy assessment tool to evaluated for 3 signs of the disease (erythema, pustules/vesicle and desquamation/scale) as sub-scores on palms or soles. The PPPASI total scores are calculated by sum of the sub-scores and range from 0 to 72 with a higher score indicating more severe disease. Missing values at were imputed using non-responder imputation (NRI) as the primary method, by which a participant without sufficient data for the response determination was considered a non-responder.
Measured: Weeks 2 to 14
Percentage of Participants Who Achieve a PPPASI-75 at Each Visit in Placebo-controlled Phase
PPPASI-75 is defined as >=75 percent decrease in PPPASI total score from baseline.
PPPASI is a disease-specific efficacy assessment tool to evaluated for 3 signs of the disease (erythema, pustules/vesicle and desquamation/scale) as sub-scores on palms or soles. The PPPASI total scores are calculated by sum of the sub-scores and range from 0 to 72 with a higher score indicating more severe disease. Missing values were imputed using NRI as the primary method, by which a participant without sufficient data for the response determination was considered a non-responder.
Measured: Weeks 2 to 16
Area Under the Curve (AUC) of PPPASI Total Score From Baseline Through Week 16
The AUC for PPPASI total score from baseline through Week 16 is the sum of the AUCs in each time interval specified by the dates of the visits and is calculated based on the linear trapezoidal method.
PPPASI is a disease-specific efficacy assessment tool to evaluate 3 signs of the disease (erythema, pustules/vesicle and desquamation/scale) as sub-scores on palms or soles. The PPPASI total scores are calculated by sum of the sub-scores and range from 0 to 72 with a higher score indicating more severe disease.
Measured: Baseline to Week 16
Percent Change From Baseline in PPPASI Total Score by Visit in Placebo-controlled Phase .
PPPASI is a disease-specific efficacy assessment tool to evaluated for 3 signs of the disease (erythema, pustules/vesicle and desquamation/scale) as sub-scores on palms or soles. The PPPASI total scores are calculated by sum of the sub-scores and range from 0 to 72 with a higher score indicating more severe disease. A positive change from baseline indicates a worsening of symptoms.
Measured: Baseline to Week 16
Change From Baseline in PPPASI Total Score at Week 16
PPPASI is a disease-specific efficacy assessment tool to evaluated for 3 signs of the disease (erythema, pustules/vesicle and desquamation/scale) as sub-scores on palms or soles. The PPPASI total scores are calculated by sum of the sub-scores and range from 0 to 72 with a higher score indicating more severe disease. Change from baseline based on a mixed-effects model for repeated measures with a positive change indicating a worsening of symptoms.
Measured: Baseline and Week 16
AUC for PPSI Total Score From Baseline Through Week 16
The AUC for PPSI total score from baseline through Week 16 is the sum of the AUCs in each time interval specified by the dates of the visits and is calculated based on the linear trapezoidal method. PPSI is a disease-specific assessment tool for grading the severity of PPP lesions. Evaluation of skin lesion sites are assessed separately for erythema, pustules/vesicle and desquamation/scale, which are each rated on a scale of 0 to 4. The PPSI produces a total numeric score that ranges from 0 to 12. A higher score indicates more severe disease.
Measured: Baseline to Week 16
Percent Change From Baseline in PPSI Total Score by Visit in Placebo-controlled Phase
PPSI is a disease-specific assessment tool for grading the severity of PPP lesions. Evaluation of skin lesion sites are assessed separately for erythema, pustules/vesicle and desquamation/scale, which are each rated on a scale of 0 to 4. The PPSI produces a total numeric score that ranges from 0 to 12. A higher score indicates more severe disease. A positive change from baseline indicates a worsening of symptoms.
Measured: Baseline to Week 16
Change From Baseline in PPSI Total Score at Week 16
PPSI is a disease-specific assessment tool for grading the severity of PPP lesions. Evaluation of skin lesion sites are assessed separately for erythema, pustules/vesicle and desquamation/scale, which are each rated on a scale of 0 to 4. The PPSI produces a total numeric score that ranges from 0 to 12. A higher score indicates more severe disease. Change from baseline based on a mixed-effects model for repeated measures with a positive change indicating a worsening of symptoms.
Measured: Baseline and Week 16
Percentage of Participants Achieving a PGA Score of Clear (0) or Minimal (1) by Visit in Placebo-controlled Phase
The PGA for palms and soles was used to determine the participants PPP lesions on palms and soles. Lesions on palms and soles were graded based on the following scales:
0 = Clear
- = Almost clear/Minimal
- = Mild
- = Moderate
- = Severe
- = Very severe.
The percentage of of participants with a post baseline score of 0 or 1 (responders) are reported. Missing values at were imputed using NRI as the primary method, by which a participant without sufficient data for the response determination was considered a non-responder.
Measured: Weeks 2 to 16
Percentage of Participants Achieving a PGA Score of 0 or 1 With At Least a 2 Grade Improvement by Visit in Placebo-controlled Phase.
The PGA for palms and soles was used to determine the participants PPP lesions on palms and soles. Lesions on palms and soles were graded based on the following scales:
0 = Clear
- = Almost clear/Minimal
- = Mild
- = Moderate
- = Severe
- = Very severe.
The percentage of of participants with at least a 2 grade improvement from baseline (stringent responders) are reported. issing values at were imputed using NRI as the primary method, by which a participant without sufficient data for the response determination was considered a non-responder.
Measured: Weeks 2 to 16
Change From Baseline in Participant VAS Assessment for PPP Symptoms
Participants assessed the degree of both pruritus itching and skin discomfort/pain as symptoms on hands and feet caused by PPP on a VAS. Each score ranged from 0 to 100. The left-hand boundary (0) on the VAS represents no itch/pain and the right-hand boundary (100) represents itch/pain as severe as can be imagined by participant.
Measured: Baseline and Weeks 2,4,6,8,12,16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start16 Oct 2019
- Primary completion18 Jan 2021
- Study completion7 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Palmoplantaris PustulosisStudies of the same condition, open and under way.
- More trials run by AmgenThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04057937
- Sponsor's protocol ID
- CC-10004-PPP-001
- Other IDs
- U1111-1236-1239
- Status last verified
- Jul 2024
- First submitted
- 13 Aug 2019
- Last updated
- 17 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Publications
Terui T, Okubo Y, Kobayashi S, Sano S, Morita A, Imafuku S, Tada Y, Abe M, Yaguchi M, Uehara N, Handa T, Tanaka M, Zhang W, Paris M, Murakami M. Efficacy and Safety of Apremilast for the Treatment of Japanese Patients with Palmoplantar Pustulosis: Results from a Phase 2, Randomized, Placebo-Controlled Study. Am J Clin Dermatol. 2023 Sep;24(5):837-847. doi: 10.1007/s40257-023-00788-2. Epub 2023 May 26.
PubMed 37233897Okubo Y, Terui T, Kobayashi S, Sano S, Morita A, Imafuku S, Tada Y, Abe M, Yaguchi M, Kimura T, Shimauchi J, Zhang W, Amouzadeh H, Murakami M. Exploratory Efficacy Evaluation of Apremilast for the Treatment of Japanese Patients with Palmoplantar Pustulosis: 32-Week Results from a Phase 2, Randomized, Placebo-Controlled Study. Dermatol Ther (Heidelb). 2024 Jul;14(7):1863-1873. doi: 10.1007/s13555-024-01195-z. Epub 2024 Jun 19.
PubMed 38896381
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Palmoplantar Pustulosis in Japan
- ClinicalTrials.gov ID
- NCT04057937
- Acronym / sponsor ID
- CC-10004-PPP-001
- Conditions
- Palmoplantaris Pustulosis
- Keywords
- Palmoplantar Pustulosis, CC-10004, Apremilast, Only Japanese, Efficacy, Safety, Phase 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2019 (actual)
- Primary completion
- 18 Jan 2021 (actual)
- Study completion
- 7 Jun 2021 (actual)
- First posted
- 15 Aug 2019 (actual)
- Results
- Posted 6 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate whether apremilast is better than placebo (inactive substance in the same form as the drug) for the treatment in Japanese subjects with PPP. This study also will evaluate the safety and tolerability of apremilast in Japanese subjects with PPP.CC-10004-PPP-001 is a multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase 2 study of apremilast in Japanese subjects with PPP and inadequate response to treatment with topical steroid and/or topical vitamin D3 derivative preparations.
The placebo-controlled period will be 16 weeks and patients will receive apremilast or placebo. After the 16-week placebo-controlled period, all subjects will receive apremilast for 16 weeks. All subjects will have their final study visit 4 weeks after stopping apremilast treatment.
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 |
|---|---|---|
| Placebo then Apremilast 30mg BID | Experimental | Drug: Apremilast, Drug: PlaceboParticipants received matched placebo as oral tablets twice daily (BID) for up to 16 weeks (Week 0 to Week 16). Participants who completed the placebo-controlled phase entered the active-treatment phase and received apremilast 30 mg as oral tablets BID for up to an additional 16 weeks (Week 16 to Week 32). |
| Apremilast 30 mg BID then Apremilast 30 mg BID | Experimental | Drug: ApremilastParticipants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16). Participants who completed the placebo-controlled phase entered the active-treatment phase and received apremilast 30 mg as oral tablets BID for up to an additional 16 weeks (Week 16 to Week 32). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject has a diagnosis of Palmoplantar Pustulosis with or without pustulotic arthro-osteitis (PAO) for at least 24 weeks before screening.
- Subject has a total score of PPPASI: ≥ 12 at screening and baseline.
- Subject has moderate or severe pustules/vesicles on palms or soles (PPPASI severity score: ≥ 2) at screening and baseline.
- Subject has inadequate response to treatment with topical steroid and/or topical vitamin D3 derivative preparations prior to or at screening.
Key exclusion criteria (9 listed)
- Subject has a diagnosis of plaque-type psoriasis.
- Subject has the presence of pustular psoriasis in any part of the body other than the palms and soles.
- Subject has obvious improvement during screening (≥ 5 PPPASI total score improvement during the screening).
- Subject has received any procedures for focal infection (e.g, tonsillectomy and dental therapy) within 24 weeks of baseline.
- Subject has periodontitis obviously requiring treatment at screening.
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 |
|---|---|---|
| ApremilastAlso: CC-10004Apremilast | Drug | Apremilast 30 mg BID then Apremilast 30 mg BID, Placebo then Apremilast 30mg BID |
| PlaceboPlacebo | Drug | Placebo then Apremilast 30mg BID |
Primary outcome
Percentage of Participants Who Achieve a PPPASI-50 at Week 16
Time frame: At Week 16
PPPASI-50 is defined as >= 50 percent decrease in PPPASI total score from baseline. PPPASI is a disease-specific efficacy assessment tool to evaluated for 3 signs of the disease (erythema, pustules/vesicle and desquamation/scale) as sub-scores on palms or soles. The PPPASI total scores are calculated by sum of the sub-scores and range from 0 to 72 with a higher score indicating more severe disease.
11 secondary outcomes
Percentage of Participants Who Achieve a PPPASI-50 at All Other Visits in Placebo-controlled Phase
Time frame: Weeks 2 to 14
Percentage of Participants Who Achieve a PPPASI-75 at Each Visit in Placebo-controlled Phase
Time frame: Weeks 2 to 16
Area Under the Curve (AUC) of PPPASI Total Score From Baseline Through Week 16
Time frame: Baseline to Week 16
Percent Change From Baseline in PPPASI Total Score by Visit in Placebo-controlled Phase .
Time frame: Baseline to Week 16
Change From Baseline in PPPASI Total Score at Week 16
Time frame: Baseline and Week 16
AUC for PPSI Total Score From Baseline Through Week 16
Time frame: Baseline to Week 16
Percent Change From Baseline in PPSI Total Score by Visit in Placebo-controlled Phase
Time frame: Baseline to Week 16
Change From Baseline in PPSI Total Score at Week 16
Time frame: Baseline and Week 16
Percentage of Participants Achieving a PGA Score of Clear (0) or Minimal (1) by Visit in Placebo-controlled Phase
Time frame: Weeks 2 to 16
Percentage of Participants Achieving a PGA Score of 0 or 1 With At Least a 2 Grade Improvement by Visit in Placebo-controlled Phase.
Time frame: Weeks 2 to 16
Change From Baseline in Participant VAS Assessment for PPP Symptoms
Time frame: Baseline and Weeks 2,4,6,8,12,16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 37233897Terui T, Okubo Y, Kobayashi S, Sano S, Morita A, Imafuku S, Tada Y, Abe M, Yaguchi M, Uehara N, Handa T, Tanaka M, Zhang W, Paris M, Murakami M. Efficacy and Safety of Apremilast for the Treatment of Japanese Patients with Palmoplantar Pustulosis: Results from a Phase 2, Randomized, Placebo-Controlled Study. Am J Clin Dermatol. 2023 Sep;24(5):837-847. doi: 10.1007/s40257-023-00788-2. Epub 2023 May 26.
- Background: PubMed 38896381Okubo Y, Terui T, Kobayashi S, Sano S, Morita A, Imafuku S, Tada Y, Abe M, Yaguchi M, Kimura T, Shimauchi J, Zhang W, Amouzadeh H, Murakami M. Exploratory Efficacy Evaluation of Apremilast for the Treatment of Japanese Patients with Palmoplantar Pustulosis: 32-Week Results from a Phase 2, Randomized, Placebo-Controlled Study. Dermatol Ther (Heidelb). 2024 Jul;14(7):1863-1873. doi: 10.1007/s13555-024-01195-z. Epub 2024 Jun 19.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
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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.
MD study director
Amgen
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apremilast in people with Palmoplantaris Pustulosis, run by Amgen at 22 sites in Japan.
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 5 inclusion and 9 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 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Japan. 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 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?
Yes. Results are posted in the registry (first posted 6 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants Who Achieve a PPPASI-50 at Week 16 (time frame: At 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 NCT04057937, which also lists 2 linked publications.
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 17 Jul 2024.