Ulcerative Colitis (Disorder)Phase 1/2NCT05119140
Administration of Hydroxychloroquine (Plaquenil) to African Americans and Hispanics for the Treatment of Mild to Severe Ulcerative Colitis
A Phase 1/2 study testing Hydroxychloroquine and Mesalamine in people with Ulcerative Colitis (Disorder), run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
Trial summary
The objective of this study is to assess the efficacy of hydroxychloroquine (HCQ) when combined with Mesalamine in reducing clinical and histologic disease activity in patients who have active mild to severe Ulcerative Colitis (UC) and also to assess the immunological effects of hydroxychloroquine in this population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis (Disorder)
- What is being tested?
- Hydroxychloroquine and Mesalamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Jun 2022to May 2025
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- Clinical diagnosis of mild to severe active Ulcerative Colitis (confirmed by endoscopy at screening),
- Currently taking mesalamine,
- Be an individual of non-European ancestry.
- Adult 18 years and older
Who cannot join
- Current use of biologics, steroids or other UC medications not including mesalamine.
- Presence of hepatic or renal insufficiency
- Pregnancy or lactation
- Known allergic reactions to components of the Hydroxychloroquine, Chloroquine or quinine products.
- Any pre-existing macular disease or cardiac disease.
- Treatment with another investigational drug or other intervention within 4 weeks.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory University School of Medicine
Atlanta, Georgia, 30322
Icahn School of Medicine at Mount Sinai/Mount Sinai Hospital
New York, New York, 10029
About this study
The objective of this study is to assess the efficacy of hydroxychloroquine (HCQ) when combined with Mesalamine in reducing clinical and histologic disease activity in patients who have active mild to severe Ulcerative Colitis (UC) and also to assess the immunological effects of hydroxychloroquine in this population. These outcomes will be evaluated both clinically and experimentally. In vitro, flow cytometry will be employed to measure the expression of CTLA-4 on activated CD4+CD25+CD127- Tregs from patients prior to treatment with HCQ, and then at the end of a 4 month follow up period. Suppression assays will be used to determine the functional capacity of the patient derived Tregs. Clinically, patients will be monitored for remission as defined by reduction in patient reported stool frequency and rectal bleeding (mayo sub-score 0 or 1) and endoscopically, by improvement in mucosal appearance (mayo sub-score 0 or 1), all objective measures in the mayo score.
Read the detailed description
This is a single arm study to evaluate the efficacy and immunological effect of administering Hydroxychloroquine to patients of non-European ancestry who have active mild to severe Ulcerative Colitis in spite of Mesalamine therapy. 10 Participants will be recruited in Icahn School of Medicine at Mount Sinai and 10 in Emory University (20 across all sites).
Participants 18 years and above who identify as an individual of non-European ancestry with a diagnosis of Ulcerative Colitis will be approached for the study. Participants will be recruited from Mount Sinai IBD center prior to their standard of care endoscopy. Participants who meet the study's inclusion criteria i.e. If they currently have active disease, they will be able to receive the research medication.
Participants will be administered 400mg hydroxychloroquine tablets orally for four months in addition to Mesalamine. Pre and post medication clinical, endoscopic and immunological assessments will be compared. Participants will also be followed up with bi-monthly phone calls. Participants will have a post medication colonoscopy at the end of the 4 month period.
There is a risk of retinopathy and cardiomyopathy associated with long term use of the study drug at doses greater than 6.5mg/kg for more than 5 years. Participants will be screened for existing eye and heart disease and monitored pre and post medication for any new adverse effects.
- Conditions
- Ulcerative Colitis (Disorder)
- Being tested
- Hydroxychloroquine, Mesalamine
- Keywords
- Ulcerative Colitis, Plaquenil, Hydroxychloroquine, CTLA-4, Inflammatory Bowel Disease, Non European Ancestry
- Medical subject headings
- Colitis, Ulcerative, Diabetes Mellitus, Insulin-Dependent, 12, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
400mg of hydroxychloroquine per oral daily
MesalamineDrug
the participant will maintain their current standard of care dose which can range from 1.5g to 4.8g of mesalamine per oral daily
| Study group | Role | What they receive |
|---|---|---|
| Mesalamine and Hydroxychloroquine | Experimental | All participants will be on Mesalamine and Hydroxychloroquine Receives: Drug: Hydroxychloroquine; Drug: Mesalamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in surface CTLA4 expression
Flow cytometry will be used to measure the expression of CTLA-4 on activated CD4+CD25+CD127- Tregs from patients prior to treatment with Hydroxychloroquine, and then at the end of a 4 month follow up period.
Measured: baseline and 4 months
Secondary outcomes (2)
Change in Endoscopy Mayo Score
Endoscopic remission will be measured using the mayo score which ranges from 0-3 with 0 meaning remission and 3 indication severe disease. Premedication endoscopy mayo score will be compared to end of study mayo score (at 4 months)
Measured: baseline and 4 months
Change in Partial Mayo Score
Change in patient reported symptoms for stool frequency and rectal bleeding are objective measures in the partial mayo score which ranges from 0-3 for both parameters. A score of zero indicates remission and a score on 3 indicates severe disease. Pre-medication partial mayo scores will be compared to end of study partial mayo scores (at 4 months)
Measured: baseline and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2021
- Study start10 Jun 2022
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (Disorder)Studies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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 1/2
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an Open Label study with blinded scorer for endoscopy and pathology reports.
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Crohn's and Colitis Foundation
- Responsible party
- Principal investigator, Judy Cho, Icahn School of Medicine at Mount Sinai
- Investigators
- Judy H Cho, MD, Principal investigator, Icahn School of Medicine at Mount SinaiSubra Kugathasan, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119140
- Sponsor's protocol ID
- GCO 20-0187
- Status last verified
- Feb 2025
- First submitted
- 20 Oct 2021
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of Hydroxychloroquine (Plaquenil) to African Americans and Hispanics for the Treatment of Mild to Severe Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT05119140
- Acronym / sponsor ID
- GCO 20-0187
- Conditions
- Ulcerative Colitis (Disorder)
- Keywords
- Ulcerative Colitis, Plaquenil, Hydroxychloroquine, CTLA-4, Inflammatory Bowel Disease, Non European Ancestry
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Crohn's and Colitis Foundation
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 12 Nov 2021 (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 objective of this study is to assess the efficacy of hydroxychloroquine (HCQ) when combined with Mesalamine in reducing clinical and histologic disease activity in patients who have active mild to severe Ulcerative Colitis (UC) and also to assess the immunological effects of hydroxychloroquine in this population. These outcomes will be evaluated both clinically and experimentally. In vitro, flow cytometry will be employed to measure the expression of CTLA-4 on activated CD4+CD25+CD127- Tregs from patients prior to treatment with HCQ, and then at the end of a 4 month follow up period. Suppression assays will be used to determine the functional capacity of the patient derived Tregs. Clinically, patients will be monitored for remission as defined by reduction in patient reported stool frequency and rectal bleeding (mayo sub-score 0 or 1) and endoscopically, by improvement in mucosal appearance (mayo sub-score 0 or 1), all objective measures in the mayo score.
Detailed description
This is a single arm study to evaluate the efficacy and immunological effect of administering Hydroxychloroquine to patients of non-European ancestry who have active mild to severe Ulcerative Colitis in spite of Mesalamine therapy. 10 Participants will be recruited in Icahn School of Medicine at Mount Sinai and 10 in Emory University (20 across all sites).
Participants 18 years and above who identify as an individual of non-European ancestry with a diagnosis of Ulcerative Colitis will be approached for the study. Participants will be recruited from Mount Sinai IBD center prior to their standard of care endoscopy. Participants who meet the study's inclusion criteria i.e. If they currently have active disease, they will be able to receive the research medication.
Participants will be administered 400mg hydroxychloroquine tablets orally for four months in addition to Mesalamine. Pre and post medication clinical, endoscopic and immunological assessments will be compared. Participants will also be followed up with bi-monthly phone calls. Participants will have a post medication colonoscopy at the end of the 4 month period.
There is a risk of retinopathy and cardiomyopathy associated with long term use of the study drug at doses greater than 6.5mg/kg for more than 5 years. Participants will be screened for existing eye and heart disease and monitored pre and post medication for any new adverse effects.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an Open Label study with blinded scorer for endoscopy and pathology reports.
| Arm | Type | Receives |
|---|---|---|
| Mesalamine and Hydroxychloroquine | Experimental | Drug: Hydroxychloroquine, Drug: MesalamineAll participants will be on Mesalamine and Hydroxychloroquine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of mild to severe active Ulcerative Colitis (confirmed by endoscopy at screening),
- Currently taking mesalamine,
- Be an individual of non-European ancestry.
- Adult 18 years and older
Key exclusion criteria (6 listed)
- Current use of biologics, steroids or other UC medications not including mesalamine.
- Presence of hepatic or renal insufficiency
- Pregnancy or lactation
- Known allergic reactions to components of the Hydroxychloroquine, Chloroquine or quinine products.
- Any pre-existing macular disease or cardiac disease.
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 |
|---|---|---|
| Hydroxychloroquine400mg of hydroxychloroquine per oral daily | Drug | Mesalamine and Hydroxychloroquine |
| Mesalaminethe participant will maintain their current standard of care dose which can range from 1.5g to 4.8g of mesalamine per oral daily | Drug | Mesalamine and Hydroxychloroquine |
Primary outcome
Change in surface CTLA4 expression
Time frame: baseline and 4 months
Flow cytometry will be used to measure the expression of CTLA-4 on activated CD4+CD25+CD127- Tregs from patients prior to treatment with Hydroxychloroquine, and then at the end of a 4 month follow up period.
2 secondary outcomes
Change in Endoscopy Mayo Score
Time frame: baseline and 4 months
Change in Partial Mayo Score
Time frame: baseline and 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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.
Judy H Cho, MD principal investigator
Icahn School of Medicine at Mount Sinai
Subra Kugathasan, MD principal investigator
Emory University
2 sites 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 Hydroxychloroquine and Mesalamine in people with Ulcerative Colitis (Disorder), run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
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 6 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: under way, not looking for participants, as of the sponsor's last update on 11 Feb 2025. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in surface CTLA4 expression (time frame: baseline and 4 months). 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 11 Feb 2025.