Ulcerative ColitisPhase 2CrocodexNCT01171807
Erythrocytes-Mediated Delivery Of Dexamethasone 21-Phosphate In Steroid-Dependent Ulcerative Colitis
A Phase 2 study testing Dex 21-P in people with Ulcerative Colitis, run by Quince Therapeutics S.p.A. at 1 site in Italy.
Trial summary
Objectives: The primary objective of this trial was to evaluate the patients response rate at the end of the study. Patients were considered responder if one of the following conditions occurs: Disease remission (Powell Tuck ≤ 3 or CDAI < 150) and withdrawal of oral steroids therapy from at least the second treatment… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Dex 21-P
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteItaly
- Study dates
- 22 Jul 2003to 15 May 2007
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- More than 18 years of age
- Patients suffering from one of the following chronic inflammatory intestinal disease:
- Steroid-dependent Chron's Disease or Ulcerative Colitis following ECCO definition or mild-moderate active UC ( Powell Tuck between 3 and 14- an index of 14 was allowed; endoscopic Baron score >1) refractory to mesalazine.
- Disease extension over the rectum (at least 15 cm) in patients suffering from Ulcerative Colitis
- Patients willing and be able to give written informed consent.
Who cannot join
- Intestinal sub occlusion or a suspected abdomen abscess or a severe degree of the disease (CDAI > 450) in patient suffering from Chron's Disease
- Patient affected by a severe Ulcerative Colitis (more than 6 evacuations of liquid, mucous-blooding stools combined at least one systemic sign as body temperature > 37.8 °C, heart rate < 90 bpm, ESR > 30 mm/h or haemoglobin < 10.5 g/dL)
- Severe concurrent disease(s) as:
- Medullar deficit: white blood cells < 3000/mm3; platelets < 75000/mm3; haemoglobin < 10 g/dL;
- Hepatic diseases presenting total bilirubin ≥ 3 mg/dL; AST (GOT) ≥ 5 UNL; alkaline phosphatase ≥ 5 UNL:
- Renal failure with serum creatinine ≥ 3 mg/dL;
Show all 16Show fewer
- Heart failure
- Respiratory failure
- Disabling neurological diseases
- Neoplasia
- Patient deemed candidate to surgery due to Chron's Disease or Ulcerative Colitis
- Chronic alcohol or drug abuse
- Patient for whom the use of steroids is contraindicated (e.g. systemic infections)
- Treatment with Infliximab in the previous 4 months
- Pregnant woman or female for whom the possibility of a pregnancy during the study could not be excluded.
- Non-collaborating patient or subject unable to regularly undergo the scheduled study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexamethasone Intra-Erythrocyte Therapy in Patients With Chron's Disease or Ulcerative Colitis
Objectives:
The primary objective of this trial was to evaluate the patients response rate at the end of the study.
Read more
Patients were considered responder if one of the following conditions occurs:
- Disease remission (Powell Tuck ≤ 3 or CDAI < 150) and withdrawal of oral steroids therapy from at least the second treatment procedure;
- Disease marked improvement versus basal conditions (at least 5 point decrease in Powell Tuck index or 150 point decrease in CDAI score) and withdrawal of oral steroids therapy from at least the second treatment procedure.
Secondary objectives:
- to evaluate the endogenous cortisole production after receiving the study treatment
- to evaluate the inflammatory indexes (ESR and CPR) after receiving the study treatment
- to evaluate the endoscopic remission in patients suffering from mesalazine refractory Ulcerative Colitis
- to evaluate the safety of dexamethasone intra-erythrocyte therapy with particular attention to steroid-related adverse events.
Read the detailed description
This was a single-center, placebo-controlled, randomised, phase II explorative study with the aim to investigate the ability of the new steroid delivery system to induce or maintain remission in steroid-dependent or mesalazine refractory patients suffering from Chron's disease (CD) or Ulcerative Colitis (UC) .
Once the patient was deemed eligible for the study, the treatment plan was selected as follows
In the Dexamethasone arm (DEX 21-P):
- steroid-dependant patients: one treatment procedure every 30 days up to a total of 6 procedures
- mesalazine refractory active UC patients: one treatment procedure every 15 days up to a total of 3 procedures.
In the placebo arm:
Patients assigned to placebo arm performed the same procedure as the patients assigned to the DEX 21-P group without loading in the Red Blood Cells the Dex 21-P.
The planned duration of individual patient participation in the study was a maximum of 6 or 28 weeks, depending from the assigned treatment scheme.
- Conditions
- Ulcerative Colitis
- Being tested
- Dex 21-P, Placebo
- Keywords
- Ulcerative colitis, Steroid-dependency, Steroid adverse events, Erythrocytes
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dex 21-PDrug
Also called Dexamethasone 21-phosphate
At each procedure 50 ml of patient whole blood was washed with saline solution and centrifugated. The isolated erythrocytes were suspended into 2 hypotonic solutions to make their membrane permeable and incubated with Dex 21-P sodium salt up to obtain a final concentration of 10 mM. The drug loaded erythrocytes were immediately re-infused by using a suitable filter.
PlaceboDrug
Patients assigned to placebo arm performed the same procedure as the patients assigned to the DEX 21-P group without loading in the Red Blood Cells the Dex 21-P
| Study group | Role | What they receive |
|---|---|---|
| Dex 21-P | Experimental | In this arm a dose of 20 ml of Dex 2-P solution was administered every 15 or 30 days for a total of 3 or 6 treatment procedures, respectively.
Specifically, steroid-dependant IBD patients had to undergo a total of 6 procedures at one month interval, while active mesalazine refractory UC patients had to undergo a total of 3 procedures at 15 days interval.
Every procedure implies the collection and re-infusion of autologous erythrocytes previously loaded with Dex 21-P. Receives: Drug: Dex 21-P |
| Placebo | Placebo comparator | In this arm placebo solution was administered every 15 or 30 days for a total of 3 or 6 treatment procedures, respectively.
Specifically, steroid-dependant IBD patients had to undergo a total of 6 procedures at one month interval, while active mesalazine refractory UC patients had to undergo a total of 3 procedures at 15 days interval.
Every procedure implies the collection and re-infusion of autologous erythrocytes previously NOT loaded with Dex21-P. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion of Patients Responders to Dex 21-P vs Placebo
Patients were considered responder if, at the EoS, one of the following occurred:
- Disease remission (Powell Tuck index ≤ 3 or CDAI < 150) and withdrawal of oral steroids therapy from at least the second treatment procedure;
- Disease marked improvement vs basal conditions (at least 5 point decrease in Powell Tuck or 150 point decrease in CDAI score) and withdrawal of oral steroids therapy from at least the second treatment procedure.
The Powell-Tuck index was calculated by adding the subscores given by 7 items. A total score < 10 indicated a mild activity of the UC, and a total score >14 a severe one. The higher the score the worse the outcome.
Crohn Disease Activity Index (CDAI) was a tool that combines subjective parameters, with objectives parameters. The score given to each parameter was inserted in an algorithm which provided the final Index value. A moderate CD showed a CDAI score between 220 and 450, while a CDAI > 450 was an activity index indicating a severe disease.
Measured: From baseline to End of treatment = 6 weeks ± 10 days (in chronic and steroid dependent IBD patients) or 28 weeks ± 5 days (in mesalazine refractory UC patients)
Secondary outcomes (6)
Change From Baseline in Endogenous Cortisole Blood Level After Receiving the Study Treatment
Blood levels of endogenous cortisol were determined before the first and 15 days/one month after the last intra-erythrocytes infusion, according to the assigned treatment scheme planned for each patient. As steroids suppress ACTH production resulting in lowering cortisol levels, the assessment of this parameter was intended to investigate the ability of the dexamethasone intra-erythrocytes administration in minimising this steroid adverse effect.
In child, from 1 to 16 years, the total serum cortisol reference range is 5-23 mcg/dL at 8 am, and 3-13 mcg/dL at 4 pm.
Measured: From baseline to End of treatment = 6 weeks ± 10 days (in chronic and steroid dependent IBD patients) or 28 weeks ± 5 days (in mesalazine refractory UC patients)
Change From Baseline in Inflammatory Indexes After Receiving the Study Treatment: Erythrocyte Sedimentation Rate (ESR)
The erythrocyte sedimentation rate (ESR) is the rate at which red blood cells in anticoagulated whole blood descend in a standardized tube over a period of one hour. It is a common hematology test, and is a non-specific measure of inflammation. To perform the test, anticoagulated blood is traditionally placed in an upright tube (Westergren tube) and the distance which the red blood cells fall is measured and reported in millimetres at the end of one hour. ESR was evaluated as supportive data for the assessment of the intestinal disease severity. It was determined before the first and 15 days/one month after the last intra-erythrocytes infusion, according to the assigned treatment scheme planned for each patient.
ESR normal values in blood were from 0 to 20 mm/hour. Higher values are considered abnormal both in adults and in children. For ESR values > 100 mm/hour, there is a high probability that an underlying cause would be found upon investigation.
Measured: From baseline to End of treatment = 6 weeks ± 10 days (in chronic and steroid dependent IBD patients) or 28 weeks ± 5 days (in mesalazine refractory UC patients)
Change From Baseline in Inflammatory Indexes After Receiving the Study Treatment: C-reactive Protein (CRP)
CRP is a protein produced by the liver. A C-reactive protein test measures the level of C-reactive protein (CRP) in a blood sample. Normal levels of blood C-reactive protein are low (0.3 to 1.0 mg/L). In case of inflammation liver releases more CRP into your bloodstream: results equal to or greater than 8 mg/L or 10 mg/L are considered high. High levels of CRP may indicate a serious health condition that causes inflammation.
C-reactive protein (CRP) was determined before the first and 15 days/one month after the last intra-erythrocytes infusion, according to the assigned treatment scheme planned for each patient.
Inflammation parameters (CRP) were evaluated as supportive data for the assessment of the intestinal disease severity.
C-reactive protein was measured in milligrams per liter (mg/L). Results equal to or greater than 8 mg/L or 10 mg/L were considered high.
Measured: From baseline to End of treatment = 6 weeks ± 10 days (in chronic and steroid dependent IBD patients) or 28 weeks ± 5 days (in mesalazine refractory UC patients)
Count of Partecipants, Suffering From Mesalazine Refractory UC, With Modification in Endoscopic Result (Baron Score)
The Baron score was an endoscopic grading system for ulcerative colitis. Four grades are defined (0-3) by the Baron score according to the severity of macroscopic inflammation of the rectal mucosal appearances at rigid sigmoidoscopy: 0 = normal mucosa (ramifying vascular pattern clearly visible, no spontaneous bleeding, no bleeding to light touch);
- = abnormal mucosa but non-haemorrhagic appearances between scores 0 and 2;
- = moderately haemorrhagic (bleeding to light touch, but no spontaneous bleeding seen ahead of the instrument on initial inspection); 3= severely haemorrhagic (spontaneous bleeding seen ahead of instrument at initial inspection and bleeds to light touch).
The higher the score the worst the outcome. Due to the nature of the score, its assessment was limited to patients suffering from UC, only. (CD or UC steroid-dependant patients were planned to receive the study treatment procedure every 30 days for a total of 6 administrations)
Measured: From baseline to End of treatment = 28 weeks ± 5 days (in mesalazine refractory UC patients)
Number of Patients Experiencing at Least One TEAE (Not Steroid-related)
At each access to the clinic (except at the baseline visit one), patients were questioned and/or examined for evidence of adverse events. An adverse event was defined as any untoward medical occurrence or unfavourable and unintended sign in a subject administered a pharmaceutical product, biologic (at any dose), or medical device, whether or not considered related to the use of that product. This includes the onset of new illness and the exacerbation of pre-existing conditions.
Measured: From baseline to End of treatment = 6 weeks ± 10 days (in chronic and steroid dependent IBD patients) or 28 weeks ± 5 days (in mesalazine refractory UC patients)
Number of Patients Experiencing at Least One TEAE (Steroid-related)
Steroid related adverse events were investigated to assess the ability of the therapeutic approach under study in reducing the occurrence or entity of steroid adverse effects.
Measured: From baseline to End of treatment = 6 weeks ± 10 days (in chronic and steroid dependent IBD patients) or 28 weeks ± 5 days (in mesalazine refractory UC patients)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2010 (estimated)
- Study start22 Jul 2003
- Primary completion15 May 2007
- Study completion15 May 2007
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 (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quince Therapeutics S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Casa Sollievo della Sofferenza IRCCS
- Responsible party
- Sponsor
- Investigators
- Angelo Andriulli, MD, Principal investigator, Casa Sollievo della Sofferenza Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01171807
- Sponsor's protocol ID
- Crocodex
- Other IDs
- 2018-004763-31, 2018
- Acronym
- Crocodex
- Status last verified
- Apr 2024
- First submitted
- 28 Jul 2010
- Last updated
- 24 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bossa F, Annese V, Valvano MR, Latiano A, Martino G, Rossi L, Magnani M, Palmieri O, Serafini S, Damonte G, De Santo E, Andriulli A. Erythrocytes-mediated delivery of dexamethasone 21-phosphate in steroid-dependent ulcerative colitis: a randomized, double-blind Sham-controlled study. Inflamm Bowel Dis. 2013 Aug;19(9):1872-9. doi: 10.1097/MIB.0b013e3182874065.
PubMed 23714676
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone Intra-Erythrocyte Therapy in Patients With Chron's Disease or Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT01171807
- Acronym / sponsor ID
- Crocodex / Crocodex
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative colitis, Steroid-dependency, Steroid adverse events, Erythrocytes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Quince Therapeutics S.p.A.Industry (pharma, biotech, devices)
- Collaborators
- Casa Sollievo della Sofferenza IRCCS
- Study start
- 22 Jul 2003 (actual)
- Primary completion
- 15 May 2007 (actual)
- Study completion
- 15 May 2007 (actual)
- First posted
- 29 Jul 2010 (estimated)
- Results
- Posted 24 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives:
The primary objective of this trial was to evaluate the patients response rate at the end of the study.
Patients were considered responder if one of the following conditions occurs:
- Disease remission (Powell Tuck ≤ 3 or CDAI < 150) and withdrawal of oral steroids therapy from at least the second treatment procedure;
- Disease marked improvement versus basal conditions (at least 5 point decrease in Powell Tuck index or 150 point decrease in CDAI score) and withdrawal of oral steroids therapy from at least the second treatment procedure.
Secondary objectives:
- to evaluate the endogenous cortisole production after receiving the study treatment
- to evaluate the inflammatory indexes (ESR and CPR) after receiving the study treatment
- to evaluate the endoscopic remission in patients suffering from mesalazine refractory Ulcerative Colitis
- to evaluate the safety of dexamethasone intra-erythrocyte therapy with particular attention to steroid-related adverse events.
Detailed description
This was a single-center, placebo-controlled, randomised, phase II explorative study with the aim to investigate the ability of the new steroid delivery system to induce or maintain remission in steroid-dependent or mesalazine refractory patients suffering from Chron's disease (CD) or Ulcerative Colitis (UC) .
Once the patient was deemed eligible for the study, the treatment plan was selected as follows
In the Dexamethasone arm (DEX 21-P):
- steroid-dependant patients: one treatment procedure every 30 days up to a total of 6 procedures
- mesalazine refractory active UC patients: one treatment procedure every 15 days up to a total of 3 procedures.
In the placebo arm:
Patients assigned to placebo arm performed the same procedure as the patients assigned to the DEX 21-P group without loading in the Red Blood Cells the Dex 21-P.
The planned duration of individual patient participation in the study was a maximum of 6 or 28 weeks, depending from the assigned treatment scheme.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dex 21-P | Experimental | Drug: Dex 21-PIn this arm a dose of 20 ml of Dex 2-P solution was administered every 15 or 30 days for a total of 3 or 6 treatment procedures, respectively. Specifically, steroid-dependant IBD patients had to undergo a total of 6 procedures at one month interval, while active mesalazine refractory UC patients had to undergo a total of 3 procedures at 15 days interval. Every procedure implies the collection and re-infusion of autologous erythrocytes previously loaded with Dex 21-P. |
| Placebo | Placebo comparator | Drug: PlaceboIn this arm placebo solution was administered every 15 or 30 days for a total of 3 or 6 treatment procedures, respectively. Specifically, steroid-dependant IBD patients had to undergo a total of 6 procedures at one month interval, while active mesalazine refractory UC patients had to undergo a total of 3 procedures at 15 days interval. Every procedure implies the collection and re-infusion of autologous erythrocytes previously NOT loaded with Dex21-P. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- More than 18 years of age
- Patients suffering from one of the following chronic inflammatory intestinal disease:
- Disease extension over the rectum (at least 15 cm) in patients suffering from Ulcerative Colitis
- Patients willing and be able to give written informed consent.
Key exclusion criteria (16 listed)
- Intestinal sub occlusion or a suspected abdomen abscess or a severe degree of the disease (CDAI > 450) in patient suffering from Chron's Disease
- Patient affected by a severe Ulcerative Colitis (more than 6 evacuations of liquid, mucous-blooding stools combined at least one systemic sign as body temperature > 37.8 °C, heart rate < 90 bpm, ESR > 30 mm/h or haemoglobin < 10.5 g/dL)
- Severe concurrent disease(s) as:
- Treatment with Infliximab in the previous 4 months
- Pregnant woman or female for whom the possibility of a pregnancy during the study could not be excluded.
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 |
|---|---|---|
| Dex 21-PAlso: Dexamethasone 21-phosphateAt each procedure 50 ml of patient whole blood was washed with saline solution and centrifugated. The isolated erythrocytes were suspended into 2 hypotonic solutions to make their membrane permeable and incubated with Dex 21-P sodium salt up to obtain a final concentration of 10 mM. The drug loaded erythrocytes were immediately re-infused by using a suitable filter. | Drug | Dex 21-P |
| PlaceboPatients assigned to placebo arm performed the same procedure as the patients assigned to the DEX 21-P group without loading in the Red Blood Cells the Dex 21-P | Drug | Placebo |
Primary outcome
The Proportion of Patients Responders to Dex 21-P vs Placebo
Time frame: From baseline to End of treatment = 6 weeks ± 10 days (in chronic and steroid dependent IBD patients) or 28 weeks ± 5 days (in mesalazine refractory UC patients)
Patients were considered responder if, at the EoS, one of the following occurred: * Disease remission (Powell Tuck index ≤ 3 or CDAI < 150) and withdrawal of oral steroids therapy from at least the second treatment procedure; * Disease marked improvement vs basal conditions (at least 5 point decrease in Powell Tuck or 150 point decrease in CDAI score) and withdrawal of oral steroids therapy from at least the second treatment procedure. The Powell-Tuck index was calculated by adding the subscores given by 7 items. A total score < 10 indicated a mild activity of the UC, and a total score >14 a severe one. The higher the score the worse the outcome. Crohn Disease Activity Index (CDAI) was a tool that combines subjective parameters, with objectives parameters. The score given to each parameter was inserted in an algorithm which provided the final Index value. A moderate CD showed a CDAI score between 220 and 450, while a CDAI > 450 was an activity index indicating a severe disease.
6 secondary outcomes
Change From Baseline in Endogenous Cortisole Blood Level After Receiving the Study Treatment
Time frame: From baseline to End of treatment = 6 weeks ± 10 days (in chronic and steroid dependent IBD patients) or 28 weeks ± 5 days (in mesalazine refractory UC patients)
Change From Baseline in Inflammatory Indexes After Receiving the Study Treatment: Erythrocyte Sedimentation Rate (ESR)
Time frame: From baseline to End of treatment = 6 weeks ± 10 days (in chronic and steroid dependent IBD patients) or 28 weeks ± 5 days (in mesalazine refractory UC patients)
Change From Baseline in Inflammatory Indexes After Receiving the Study Treatment: C-reactive Protein (CRP)
Time frame: From baseline to End of treatment = 6 weeks ± 10 days (in chronic and steroid dependent IBD patients) or 28 weeks ± 5 days (in mesalazine refractory UC patients)
Count of Partecipants, Suffering From Mesalazine Refractory UC, With Modification in Endoscopic Result (Baron Score)
Time frame: From baseline to End of treatment = 28 weeks ± 5 days (in mesalazine refractory UC patients)
Number of Patients Experiencing at Least One TEAE (Not Steroid-related)
Time frame: From baseline to End of treatment = 6 weeks ± 10 days (in chronic and steroid dependent IBD patients) or 28 weeks ± 5 days (in mesalazine refractory UC patients)
Number of Patients Experiencing at Least One TEAE (Steroid-related)
Time frame: From baseline to End of treatment = 6 weeks ± 10 days (in chronic and steroid dependent IBD patients) or 28 weeks ± 5 days (in mesalazine refractory UC patients)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23714676Bossa F, Annese V, Valvano MR, Latiano A, Martino G, Rossi L, Magnani M, Palmieri O, Serafini S, Damonte G, De Santo E, Andriulli A. Erythrocytes-mediated delivery of dexamethasone 21-phosphate in steroid-dependent ulcerative colitis: a randomized, double-blind Sham-controlled study. Inflamm Bowel Dis. 2013 Aug;19(9):1872-9. doi: 10.1097/MIB.0b013e3182874065.
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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.
Angelo Andriulli, MD principal investigator
Casa Sollievo della Sofferenza 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 Dex 21-P in people with Ulcerative Colitis, run by Quince Therapeutics S.p.A. at 1 site in Italy.
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 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 24 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 Italy. 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?
Yes. Results are posted in the registry (first posted 24 Sep 2024). 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?
The Proportion of Patients Responders to Dex 21-P vs Placebo (time frame: From baseline to End of treatment = 6 weeks ± 10 days (in chronic and steroid dependent IBD patients) or 28 weeks ± 5 days (in mesalazine refractory UC patients)). 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 NCT01171807, which also lists 1 linked publication.
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 24 Sep 2024.