Primary Sclerosing CholangitisPhase 2SHIPNCT03561584
Sulfasalazine for the Treatment of Primary Sclerosing Cholangitis
A Phase 2 study testing Sulfasalazine in people with Primary Sclerosing Cholangitis, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This is a multicenter, randomized, double-blinded placebo controlled trial to assess the benefit of sulfasalazine in the treatment of PSC. The specific objectives of this study are to determine if sulfasalazine treatment 1) results in reduced serum ALP and other biomarkers of liver injury in PSC; 2) improves PSC… Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Primary Sclerosing Cholangitis
- What is being tested?
- Sulfasalazine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 3 Mar 2026
- Phase
- Phase 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 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 15-80
- A diagnosis of PSC for at least 6 months based upon cholangiography (ERCP or MRCP) demonstrating intrahepatic and/or extrahepatic biliary strictures, beading or irregularity consistent with PSC.
- ALP > 1.67 times the upper limit of normal (ULN) at screening
- Inflammatory bowel disease
- Subject must either be on a stable dose of ursodeoxycholic acid for > 6 months prior to screening or have been discontinued > 4 weeks prior to screening (enrollment of patients who are on UDCA will be limited to 50% of all enrolled patients).
- We are recruiting remotely throughout the United States so an individual anywhere in the US with PSC and IBD can be enrolled.
Who cannot join
- Anticipated need for liver transplant within one year as determined by Mayo PSC risk score treatment
- Evidence of decompensated liver disease such as variceal bleeding, ascites, or hepatic encephalopathy.
- Evidence of advanced liver disease including MELD score > 10, bilirubin > 3.0, platelet count < 100,000; or INR > 1.4
- Concomitant chronic liver disease including alcohol related liver disease, chronic hepatitis B or C infection, haemochromatosis, Wilson's disease, alpha1-antitrypsin deficiency, non-alcoholic steatohepatitis, autoimmune hepatitis, or primary biliary cholangitis
- Secondary causes of sclerosing cholangitis
- Known intolerance to sulfasalazine (including but not limited to allergy to sulfa or mesalamine) or folic acid
Show all 16Show fewer
- History of cholangiocarcinoma or colon cancer within 5 years
- History of colectomy with > 1/3 bowel resected
- Treatment with any investigational agents, within two months or 5 half-lives of the investigational product, whichever is longer.
- Active illicit drug or alcohol abuse
- Current or past use of sulfasalazine within 6 months of enrollment.
- Need for chronic use of antibiotics
- Evidence of bacterial cholangitis within 6 months of enrollment
- In patients with Ulcerative Colitis, simple clinical colitis activity index of > 4 or, if Crohn's disease, a Harvey-Bradshaw index of > 5
- Chronic kidney injury (eGFR < 59)
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, 02467
About this study
Official title: A Randomized, Placebo-controlled Pilot Study of Sulfasalazine for the Treatment of Primary Sclerosing Cholangitis (PSC)
This is a multicenter, randomized, double-blinded placebo controlled trial to assess the benefit of sulfasalazine in the treatment of PSC. The specific objectives of this study are to determine if sulfasalazine treatment 1) results in reduced serum ALP and other biomarkers of liver injury in PSC; 2) improves PSC patient symptoms; and 3) is safe in patients with PSC.
We are recruiting remotely throughout the United States so an individual anywhere in the US with PSC and IBD can be enrolled.
Read the detailed description
As there is a strong association between PSC and IBD, it is reasonable to hypothesize that a therapy of proven benefit for UC may prove to also be effective for PSC. Unfortunately, several therapies which are indicated for the treatment of UC have not been effective in PSC including anti-TNF therapies and other anti-inflammatory medications. Sulfasalazine and mesalamine, medications commonly used for the treatment of UC, may be exceptions to this trend. While this therapy has never been formally tested in PSC, some retrospective reports suggest a possible benefit. Our current understanding of the mechanism of action of these medications suggests there is reasonable to believe they may also be effective in PSC.
We are recruiting remotely throughout the United States so an individual anywhere in the US with PSC and IBD can be enrolled.
- Conditions
- Primary Sclerosing Cholangitis
- Being tested
- Sulfasalazine, Placebo
- Keywords
- Sclerosing, Cholangitis
- Medical subject headings
- Cholangitis, Sclerosing, Cholangitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SulfasalazineDrug
Also called Azulfidine
Patients will be initiated on a low dose of sulfasalazine (500 mg) twice daily (bid). Dosage will be increased throughout the study.
PlaceboDrug
Patients will be initiated on 1 placebo tablet twice daily (bid). Dosage will be increased throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| Active Drug (Sulfasalazine) | Active comparator | Not described Receives: Drug: Sulfasalazine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Mean Alkaline Phosphatase (ALP)
Proportion of patients with reduction of mean ALP < 1.5 x ULN at end of treatment
Measured: Baseline through the end of the Study at Week 22
Normalization of ALP below the upper limit of normal
Assessment in number of patients whose ALP normalizes
Measured: Baseline through the end of the Study at Week 22
Secondary outcomes (6)
Overall changes in ALP levels
Proportion of patients with ALP > or < 1.5 x ULN at end of treatment
Measured: Baseline through the end of the Study at Week 22
Changes in blood tests
Change in mean Liver Function Tests (e.g. Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), total bilirubin) and C-reactive Protein
Measured: Baseline through the end of the Study at Week 22
Adverse Events
Unexpected and Serious Adverse Events will be examined
Measured: Baseline through the end of the Study at Week 22
Changes in Mayo PSC risk score
Number of patients with changes in Mayo PSC risk score
Measured: Baseline through the end of the Study at Week 22
Changes in Modified Fatigue Scale (MFS)
Number of patients with changes in MFS score
Measured: Baseline through the end of the Study at Week 22
Changes in pruritus visual analog scale (VAS)
Number of patients with changes in VAS score
Measured: Baseline through the end of the Study at Week 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start1 Jul 2018
- Primary completion3 Mar 2026
- Study completion3 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sclerosing CholangitisStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Sequential
- Model description
- There are two arms in this trial: active drug and placebo. We are recruiting remotely throughout the United States so an individual anywhere in the US with PSC and IBD can be enrolled.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua Korzenik, Brigham and Women's Hospital
- Investigators
- Joshua R Korzenik, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03561584
- Sponsor's protocol ID
- 2018P000019
- Acronym
- SHIP
- Status last verified
- Mar 2026
- First submitted
- 14 May 2018
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled Pilot Study of Sulfasalazine for the Treatment of Primary Sclerosing Cholangitis (PSC)
- ClinicalTrials.gov ID
- NCT03561584
- Acronym / sponsor ID
- SHIP / 2018P000019
- Conditions
- Primary Sclerosing Cholangitis
- Keywords
- Sclerosing, Cholangitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 3 Mar 2026 (actual)
- Study completion
- 3 Mar 2026 (actual)
- First posted
- 19 Jun 2018 (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.
This is a multicenter, randomized, double-blinded placebo controlled trial to assess the benefit of sulfasalazine in the treatment of PSC. The specific objectives of this study are to determine if sulfasalazine treatment 1) results in reduced serum ALP and other biomarkers of liver injury in PSC; 2) improves PSC patient symptoms; and 3) is safe in patients with PSC.
We are recruiting remotely throughout the United States so an individual anywhere in the US with PSC and IBD can be enrolled.
Detailed description
As there is a strong association between PSC and IBD, it is reasonable to hypothesize that a therapy of proven benefit for UC may prove to also be effective for PSC. Unfortunately, several therapies which are indicated for the treatment of UC have not been effective in PSC including anti-TNF therapies and other anti-inflammatory medications. Sulfasalazine and mesalamine, medications commonly used for the treatment of UC, may be exceptions to this trend. While this therapy has never been formally tested in PSC, some retrospective reports suggest a possible benefit. Our current understanding of the mechanism of action of these medications suggests there is reasonable to believe they may also be effective in PSC.
We are recruiting remotely throughout the United States so an individual anywhere in the US with PSC and IBD can be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- There are two arms in this trial: active drug and placebo. We are recruiting remotely throughout the United States so an individual anywhere in the US with PSC and IBD can be enrolled.
| Arm | Type | Receives |
|---|---|---|
| Active Drug (Sulfasalazine) | Active comparator | Drug: Sulfasalazine |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age 15-80
- A diagnosis of PSC for at least 6 months based upon cholangiography (ERCP or MRCP) demonstrating intrahepatic and/or extrahepatic biliary strictures, beading or irregularity consistent with PSC.
- ALP > 1.67 times the upper limit of normal (ULN) at screening
- Inflammatory bowel disease
- Subject must either be on a stable dose of ursodeoxycholic acid for > 6 months prior to screening or have been discontinued > 4 weeks prior to screening (enrollment of patients who are on UDCA will be limited to 50% of all enrolled patients).
Key exclusion criteria (16 listed)
- Anticipated need for liver transplant within one year as determined by Mayo PSC risk score treatment
- Evidence of decompensated liver disease such as variceal bleeding, ascites, or hepatic encephalopathy.
- Evidence of advanced liver disease including MELD score > 10, bilirubin > 3.0, platelet count < 100,000; or INR > 1.4
- Concomitant chronic liver disease including alcohol related liver disease, chronic hepatitis B or C infection, haemochromatosis, Wilson's disease, alpha1-antitrypsin deficiency, non-alcoholic steatohepatitis, autoimmune hepatitis, or primary biliary cholangitis
- Secondary causes of sclerosing cholangitis
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 |
|---|---|---|
| SulfasalazineAlso: AzulfidinePatients will be initiated on a low dose of sulfasalazine (500 mg) twice daily (bid). Dosage will be increased throughout the study. | Drug | Active Drug (Sulfasalazine) |
| PlaceboPatients will be initiated on 1 placebo tablet twice daily (bid). Dosage will be increased throughout the study. | Drug | Placebo |
Primary outcome
Reduction in Mean Alkaline Phosphatase (ALP)
Time frame: Baseline through the end of the Study at Week 22
Proportion of patients with reduction of mean ALP < 1.5 x ULN at end of treatment
Normalization of ALP below the upper limit of normal
Time frame: Baseline through the end of the Study at Week 22
Assessment in number of patients whose ALP normalizes
6 secondary outcomes
Overall changes in ALP levels
Time frame: Baseline through the end of the Study at Week 22
Changes in blood tests
Time frame: Baseline through the end of the Study at Week 22
Adverse Events
Time frame: Baseline through the end of the Study at Week 22
Changes in Mayo PSC risk score
Time frame: Baseline through the end of the Study at Week 22
Changes in Modified Fatigue Scale (MFS)
Time frame: Baseline through the end of the Study at Week 22
Changes in pruritus visual analog scale (VAS)
Time frame: Baseline through the end of the Study at Week 22
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 12 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Primary Sclerosing Cholangitis
RecruitingObservational study
Unraveling the Mechanisms Underlying Primary Sclerosing Cholangitis Through a Multidisciplinary, Integrative Research Approach
Primary Sclerosing Cholangitis
Not yet recruitingPhase 2
FEAST and HOPE: Redox PSC Pilot Study
Primary Sclerosing Cholangitis (PSC)
RecruitingPhase 3
A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis
Primary Sclerosing Cholangitis
Active, not recruitingPhase 2
A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis.
Primary Sclerosing Cholangitis
Active, not recruitingPhase 2
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC)
Primary Sclerosing Cholangitis
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.
Joshua R Korzenik, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sulfasalazine in people with Primary Sclerosing Cholangitis, run by Brigham and Women's Hospital at 1 site 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 6 inclusion and 16 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 12 Mar 2026. 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 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. 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 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?
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?
Reduction in Mean Alkaline Phosphatase (ALP) (time frame: Baseline through the end of the Study at Week 22). 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 12 Mar 2026.