Hidradenitis SuppurativaEarly Phase 1NCT05663268
Efficacy and Safety of Infliximab Biosimilar in the Treatment of Resistant Hidradenitis Suppurativa
A Early Phase 1 study testing Infliximab-dyyb biosimilar in people with Hidradenitis Suppurativa, run by Services Institute of Medical Sciences, Pakistan at 1 site in Pakistan.
Trial summary
The aim of this clinical trial is to assess the efficacy and safety of Infliximab-dyyb biosimilar in patients of resistant Hidradenitis suppurativa. The main question it aims to answer are: how effective is infliximab biosimilar in treating resistant Hidradentis suppurativa Is infliximab biosimilar safe in these… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Infliximab-dyyb biosimilar
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2022to 30 Sep 2023
- Phase
- Early Phase 1
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients of Hidradenitis suppurativa resistant to conventional therapy
Who cannot join
- Immunocompromised patients
- Patients with connective tissue disorders
- patients having chronic infections like heapatitis, HIV or Tuberculosis
- Pregnant or lactating mothers
- hypersensitivity to biologics
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Services Institute of Medical Sciences
Lahore, Punjab Province, 54000
About this study
The aim of this clinical trial is to assess the efficacy and safety of Infliximab-dyyb biosimilar in patients of resistant Hidradenitis suppurativa. The main question it aims to answer are:
- how effective is infliximab biosimilar in treating resistant Hidradentis suppurativa
- Is infliximab biosimilar safe in these patients Patients will receive weekly injections of Infliximab Biosimilar Remsima, according to weight, for first 4 weeks, and then fortnightly for next 24 weeks. Patients will be followed up at 4, 14 and 24 weeks for assessment of safety and efficacy
Read the detailed description
The aim of this clinical trial is to assess the efficacy and safety of Infliximab-dyyb biosimilar in patients of resistant Hidradenitis suppurativa. The main question it aims to answer are:
- how effective is infliximab biosimilar in treating resistant Hidradentis suppurativa
- Is infliximab biosimilar safe in these patients Patients will receive weekly injections of Infliximab Biosimilar Remsima, according to weight, for first 4 weeks, and then fortnightly for next 24 weeks. Patients will be followed up at 4, 14 and 24 weeks for assessment of safety and efficacy.
Pre and post treatment HiSCR, IHS4, DLQI scores and photos will be taken for comparison at week 0, 4, 14 and 24. Details will be entered on predesigned proforma DATA ANALYSIS PROCEDURE: Data will be entered and analyzed using SPSS 20. Data will be stratified for role of effect modifiers.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Infliximab-dyyb biosimilar
- Keywords
- Hidradenitis suppurativa, Infliximab biosimilar, Efficacy, safety
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infliximab-dyyb biosimilarBiological
Also called Remsima (infliximab-dyyb biosimilar)
Remsima for subcutaneous injection is a biosimilar monoclonal antibody of infliximab-dyyb that inhibits the activity of tumour necrosis factor (TNF)-alpha.
| Study group | Role | What they receive |
|---|---|---|
| Patients of Hidradenitis suppurativa resistant to conventional therapy | Experimental | injection Infliximab-dyyb biosimilar (according to weight, single injection of 120mg if weight <80kg, 2 injections if weight > 80kg) will be injected subcutaneously at week 0,1, 2,3,4, and then fortnightly till 24 weeks. Receives: Biological: Infliximab-dyyb biosimilar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hidradenitis Suppurativa Clinical Response (HiSCR)
50% reduction in score
Measured: 24 weeks
Dermatology Life Quality Index (DLQI)
50% reduction
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start1 Oct 2022
- Primary completion30 Mar 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hidradenitis SuppurativaStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Adult patients of either gender suffering from Hidradenitis suppurativa resistant to conventional therapies
- Masking
- None (open label)
- Enrolment
- 37 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
- Hira Tariq, FCPS Derma, Principal investigator, Services Institute of Medical Sciences, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05663268
- Sponsor's protocol ID
- IRB/2022/101/SIMS
- Status last verified
- Nov 2023
- First submitted
- 15 Dec 2022
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fernandez-Vozmediano JM, Armario-Hita JC. Infliximab for the treatment of hidradenitis suppurativa. Dermatology. 2007;215(1):41-4. doi: 10.1159/000102032.
PubMed 17587838Sullivan TP, Welsh E, Kerdel FA, Burdick AE, Kirsner RS. Infliximab for hidradenitis suppurativa. Br J Dermatol. 2003 Nov;149(5):1046-9. doi: 10.1111/j.1365-2133.2003.05663.x.
PubMed 14632813
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Infliximab Biosimilar in the Treatment of Resistant Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT05663268
- Acronym / sponsor ID
- IRB/2022/101/SIMS
- Conditions
- Hidradenitis Suppurativa
- Keywords
- Hidradenitis suppurativa, Infliximab biosimilar, Efficacy, safety
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Services Institute of Medical Sciences, PakistanOther government
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 23 Dec 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.
The aim of this clinical trial is to assess the efficacy and safety of Infliximab-dyyb biosimilar in patients of resistant Hidradenitis suppurativa. The main question it aims to answer are:
- how effective is infliximab biosimilar in treating resistant Hidradentis suppurativa
- Is infliximab biosimilar safe in these patients Patients will receive weekly injections of Infliximab Biosimilar Remsima, according to weight, for first 4 weeks, and then fortnightly for next 24 weeks. Patients will be followed up at 4, 14 and 24 weeks for assessment of safety and efficacy
Detailed description
The aim of this clinical trial is to assess the efficacy and safety of Infliximab-dyyb biosimilar in patients of resistant Hidradenitis suppurativa. The main question it aims to answer are:
- how effective is infliximab biosimilar in treating resistant Hidradentis suppurativa
- Is infliximab biosimilar safe in these patients Patients will receive weekly injections of Infliximab Biosimilar Remsima, according to weight, for first 4 weeks, and then fortnightly for next 24 weeks. Patients will be followed up at 4, 14 and 24 weeks for assessment of safety and efficacy.
Pre and post treatment HiSCR, IHS4, DLQI scores and photos will be taken for comparison at week 0, 4, 14 and 24. Details will be entered on predesigned proforma DATA ANALYSIS PROCEDURE: Data will be entered and analyzed using SPSS 20. Data will be stratified for role of effect modifiers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Adult patients of either gender suffering from Hidradenitis suppurativa resistant to conventional therapies
| Arm | Type | Receives |
|---|---|---|
| Patients of Hidradenitis suppurativa resistant to conventional therapy | Experimental | Biological: Infliximab-dyyb biosimilarinjection Infliximab-dyyb biosimilar (according to weight, single injection of 120mg if weight <80kg, 2 injections if weight > 80kg) will be injected subcutaneously at week 0,1, 2,3,4, and then fortnightly till 24 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients of Hidradenitis suppurativa resistant to conventional therapy
Key exclusion criteria (5 listed)
- Immunocompromised patients
- Patients with connective tissue disorders
- patients having chronic infections like heapatitis, HIV or Tuberculosis
- Pregnant or lactating mothers
- hypersensitivity to biologics
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 biosimilarAlso: Remsima (infliximab-dyyb biosimilar)Remsima for subcutaneous injection is a biosimilar monoclonal antibody of infliximab-dyyb that inhibits the activity of tumour necrosis factor (TNF)-alpha. | Biological | Patients of Hidradenitis suppurativa resistant to conventional therapy |
Primary outcome
Hidradenitis Suppurativa Clinical Response (HiSCR)
Time frame: 24 weeks
50% reduction in score
Dermatology Life Quality Index (DLQI)
Time frame: 24 weeks
50% reduction
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 29 Nov 2023.
- Results publication: PubMed 17587838Fernandez-Vozmediano JM, Armario-Hita JC. Infliximab for the treatment of hidradenitis suppurativa. Dermatology. 2007;215(1):41-4. doi: 10.1159/000102032.
- Results publication: PubMed 14632813Sullivan TP, Welsh E, Kerdel FA, Burdick AE, Kirsner RS. Infliximab for hidradenitis suppurativa. Br J Dermatol. 2003 Nov;149(5):1046-9. doi: 10.1111/j.1365-2133.2003.05663.x.
- Individual participant dataSharing planned: Undecided
Related trials for Hidradenitis Suppurativa
Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
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Active, not recruitingPhase 2
A Study of Zasocitinib in Adults With Hidradenitis Suppurativa
Hidradenitis Suppurativa
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Acceptability of MBSR for People With HS
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Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib
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ORKA-002 Versus Placebo in Participants With Moderate-to-Severe Hidradenitis Suppurativa
Hidradenitis Suppurativa (HS)
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.
Hira Tariq, 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 Early Phase 1 study testing Infliximab-dyyb biosimilar in people with Hidradenitis Suppurativa, 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 5 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 29 Nov 2023. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Hidradenitis Suppurativa Clinical Response (HiSCR) (time frame: 24 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?
On the ClinicalTrials.gov record for NCT05663268, 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 29 Nov 2023.