Moderate to Severe Chronic Plaque PsoriasisPhase 1/2NCT06591273
Efficacy and Safety of Infliximab Biosimilar in Treatment of Moderate to Severe Psoriasis; A Single-arm Clinical Trial
A Phase 1/2 study testing Infliximab-dyyb Biosimilar (Remsima) in people with Moderate to Severe Chronic Plaque Psoriasis, run by Services Institute of Medical Sciences, Pakistan at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to learn if Infliximab Biosimilar Remsima works to treat moderate to severe plaque Psoriasis in adults. It will also learn about the safety of the drug. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Moderate to Severe Chronic Plaque Psoriasis
- What is being tested?
- Infliximab-dyyb Biosimilar (Remsima)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 sitePakistan
- Study dates
- 6 Nov 2023to 5 Nov 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult Patients of moderate to severe plaque psoriasis Biologically naive patients
Who cannot join
- Patients with active or latent TB, Hepatitis B or C, HIV. Immunocompromised patients due to drugs or disease. Patients on systemic anti-psoriastic medications in last three months. Patients with personal or strong family history of heart disease. Any other medical comorbidity (hepatic or renal) or contraindication to biologic/ biosimilars.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Department of Dermatology, Services Institute of Medical Sciences/ Services Hospital
Lahore, Punjab Province, 54000
About this study
The goal of this clinical trial is to learn if Infliximab Biosimilar Remsima works to treat moderate to severe plaque Psoriasis in adults. It will also learn about the safety of the drug. The main questions it aims to answer are:
Does Infliximab-dyyb Biosimilar (Remsima) works to treat moderate to severe plaque Psoriasis in adults in reducing disease severity and relapses? What medical problems do participants have when taking Remsima?
Participants will:
be injected Infliximab Biosimilar Remsima weekly for 4 weeks and then fortnightly till 24 weeks They will be followed for efficacy and safety and lab tests at week 4, 14, 24 and 52.
- Being tested
- Infliximab-dyyb Biosimilar (Remsima)
- Keywords
- Infliximab biosimilar, Remsima, Plaque psoriasis, Biologics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infliximab-dyyb Biosimilar (Remsima)Biological
Subcutaneous injections of Infliximab-dyyb Biosimilar (Remsima) were injected weekly for 4 weeks and then fortnightly for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Adult Patients of moderate to severe plaque psoriasis | Experimental | Not described Receives: Biological: Infliximab-dyyb Biosimilar (Remsima) |
What is being measured
The primary outcome is the main question the study is designed to answer.
At least 50% reduction in PASI
PASI should reduce to at least 50% of baseline (pre-treatment)
Measured: 14 weeks
At least 50% reduction in DLQI
DLQI (Dermatology Life Quality Index) should reduce to at least 50% of baseline (pre-treatment)
Measured: 14 weeks
Secondary outcomes (2)
Maintenance of At least 50% reduction in PASI and DLQI
Maintenance of At least 50% reduction in PASI and DLQI from baseline (pre-treatment)
Measured: 24 weeks
Maintenance of At least 50% reduction in PASI and DLQI
Maintenance of At least 50% reduction in PASI and DLQI from baseline (pre-treatment)
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start6 Nov 2023
- Primary completion5 Nov 2024 (estimated)
- Study completion5 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Chronic Plaque 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Services Institute of Medical Sciences, Pakistan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hira Tariq, Services Institute of Medical Sciences, Pakistan
- Investigators
- Dr Hira Tariq, MBBS, FCPS Derma, Principal investigator, Services Institute of Medical Sciences, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591273
- Sponsor's protocol ID
- IRB/2023/1201/SIMS
- Status last verified
- Sep 2024
- First submitted
- 7 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Infliximab Biosimilar in Treatment of Moderate to Severe Psoriasis; A Single-arm Clinical Trial
- ClinicalTrials.gov ID
- NCT06591273
- Acronym / sponsor ID
- IRB/2023/1201/SIMS
- Keywords
- Infliximab biosimilar, Remsima, Plaque psoriasis, Biologics
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Services Institute of Medical Sciences, PakistanOther government
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 5 Nov 2024 (estimated)
- Study completion
- 5 Nov 2024 (estimated)
- First posted
- 19 Sep 2024 (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.
The goal of this clinical trial is to learn if Infliximab Biosimilar Remsima works to treat moderate to severe plaque Psoriasis in adults. It will also learn about the safety of the drug. The main questions it aims to answer are:
Does Infliximab-dyyb Biosimilar (Remsima) works to treat moderate to severe plaque Psoriasis in adults in reducing disease severity and relapses? What medical problems do participants have when taking Remsima?
Participants will:
be injected Infliximab Biosimilar Remsima weekly for 4 weeks and then fortnightly till 24 weeks They will be followed for efficacy and safety and lab tests at week 4, 14, 24 and 52.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult Patients of moderate to severe plaque psoriasis | Experimental | Biological: Infliximab-dyyb Biosimilar (Remsima) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult Patients of moderate to severe plaque psoriasis Biologically naive patients
Key exclusion criteria (1 listed)
- Patients with active or latent TB, Hepatitis B or C, HIV. Immunocompromised patients due to drugs or disease. Patients on systemic anti-psoriastic medications in last three months. Patients with personal or strong family history of heart disease. Any other medical comorbidity (hepatic or renal) or contraindication to biologic/ biosimilars.
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 |
|---|---|---|
| Infliximab-dyyb Biosimilar (Remsima)Subcutaneous injections of Infliximab-dyyb Biosimilar (Remsima) were injected weekly for 4 weeks and then fortnightly for 24 weeks | Biological | Adult Patients of moderate to severe plaque psoriasis |
Primary outcome
At least 50% reduction in PASI
Time frame: 14 weeks
PASI should reduce to at least 50% of baseline (pre-treatment)
At least 50% reduction in DLQI
Time frame: 14 weeks
DLQI (Dermatology Life Quality Index) should reduce to at least 50% of baseline (pre-treatment)
2 secondary outcomes
Maintenance of At least 50% reduction in PASI and DLQI
Time frame: 24 weeks
Maintenance of At least 50% reduction in PASI and DLQI
Time frame: 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Moderate to Severe Chronic Plaque Psoriasis
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A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis
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RecruitingEarly Phase 1
To Check Comparison of Apremilast and Methotrexate Efficacy in Patients With Moderate to Severe Plaque Psoriasis Presented to Tertiary Care Hospital
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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.
Dr Hira Tariq, MBBS, FCPS Derma principal investigator
Services Institute of Medical Sciences, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Infliximab-dyyb Biosimilar (Remsima) in people with Moderate to Severe Chronic Plaque Psoriasis, run by Services Institute of Medical Sciences, Pakistan at 1 site in Pakistan.
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 1 inclusion and 1 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 19 Sep 2024. 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 Pakistan. 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 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?
Results are not available in the source record.
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?
At least 50% reduction in PASI (time frame: 14 weeks). The study lists 2 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 19 Sep 2024.