Destruction of cells separated from blood outside of the body using the drug 5-aminolevulinic and blue light for up to 10 patients with Crohns disease.

Extracorporeal photopheresis of patients with Crohns disease using 5- aminolevulinic acid. - twostepala

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002422-23-NO

Enrollment

Registered

2018-07-17

Start date

2019-01-08

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohns disease MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Trade Name: Gliolan Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Provision of informed consent 2. Age above 18 3. Male or female patient with active Crohn's disease (5) 4. Inadequate response (a) or intolerance to biological therapy a. Inadequate response on ongoing treatment is defined as: i. Progressive disease: increasing HBI/Calprotectin/SES-CD and/or worsening of radiologic images after 6 months. ii. Stable disease: no-response after 6 months 5. Active inflammation in the gut documented by a. HBI>7 b. Endoscopy with SES-CD > 6 c. and/or inflammatory markers; fecal calprotectin and/or C-reactive protein (CRP). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 8 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2

Exclusion criteria

Exclusion criteria: 1. Photosensitive comorbidities, porphyria or known hypersensitivity to 5-aminolevulinic acid or porphyrins 2. Patients with aphakia 3. Pregnant or breast feeding women. A negative urine pregnancy test must be demonstrated in female patients of child-bearing potential at the Screening Visit and before every treatment. 4. Ongoing cardiac and pulmonary diseases or ASAT, ALAT, Bilirubin or INR value = 3x upper limit of normal or clinically significant ECG findings 5. Subjects with polyneuropathy 6. Uncontrolled infection or fever 7. History of heparin-induced thrombocytopenia, absolute neutrophil count <1x109 L-1, platelet count <20x109 L-1 8. Body weight below 40 kg 9. Investigator considers subject unlikely to comply with study procedures, restrictions and requirements. 10. History of any clinically significant disease or disorder which in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the result or the patient's ability to participate in the study.

Design outcomes

Primary

Measure	Time frame
Main Objective: -to assess efficacy, safety and tolerability after single and multiple treatment doses of 0.050% w/v (3 mM) 5-ALA (Gliolan®) in combination with BLUE-PIT Photopheresis System in patients with active Crohn’s disease in combination with leukapheresis (Spectra Optia with Continuous Mononuclear Cell Collection protocol) and BLUE-PIT system used for standard two-step ECP in patients with Crohns disease. ;Secondary Objective: -To assess efficacy parameters and mechanism of action, and to identify biomarkers for responsiveness after single and multiple treatment doses of 0.050% w/v (3 mM) 5-ALA (Gliolan®) in combination with BLUE-PIT Photopheresis System in patients with active Crohn’s disease. We will also address endoscopic improvement and improvement on cross sectional imaging when appropriate as secondary endpoints.;Primary end point(s): Effectiveness of treatment after 13 weeks with clinical remission Harvey Bradshaw index (HBI) < 5. Frequency, seriousness and intensity of adverse events, ECG, recording, vital signs and safety laboratory parameters. ALA and its derived porphyrins (mainly PpIX) are usually eliminated from the body within 24-48 hours after systemic administration and transiently increased activities of some transferases (ALP, ASAT, gGT) and bilirubin in the blood generally return to normal values within 72 hours. Blood parameters will be taken before every treatment and compared to baseline. Patients will be evaluated/asked regarding general health condition including know AEs of ALA (nausea, vomiting, photosensitization). Patients with x 3 upper reference blood parameters are excluded. If values rise 50%, new sample within 3 days and ALA-ECP postponed. If persistent beyond 6 days - ALA-ECP postponed till normalization. Treatment stoped if identified SAE occur. ;Timepoint(s) of evaluation of this end point: For safety/tolerability; continuous evalution before and after every treatment. Main evaluations at 13, 26, 38, 50, 64 weeks and t	—

Measure

Time frame

Main Objective: -to assess efficacy, safety and tolerability after single and multiple treatment doses of 0.050% w/v (3 mM) 5-ALA (Gliolan®) in combination with BLUE-PIT Photopheresis System in patients with active Crohn’s disease in combination with leukapheresis (Spectra Optia with Continuous Mononuclear Cell Collection protocol) and BLUE-PIT system used for standard two-step ECP in patients with Crohns disease. ;Secondary Objective: -To assess efficacy parameters and mechanism of action, and to identify biomarkers for responsiveness after single and multiple treatment doses of 0.050% w/v (3 mM) 5-ALA (Gliolan®) in combination with BLUE-PIT Photopheresis System in patients with active Crohn’s disease. We will also address endoscopic improvement and improvement on cross sectional imaging when appropriate as secondary endpoints.;Primary end point(s): Effectiveness of treatment after 13 weeks with clinical remission Harvey Bradshaw index (HBI) < 5. Frequency, seriousness and intensity of adverse events, ECG, recording, vital signs and safety laboratory parameters. ALA and its derived porphyrins (mainly PpIX) are usually eliminated from the body within 24-48 hours after systemic administration and transiently increased activities of some transferases (ALP, ASAT, gGT) and bilirubin in the blood generally return to normal values within 72 hours. Blood parameters will be taken before every treatment and compared to baseline. Patients will be evaluated/asked regarding general health condition including know AEs of ALA (nausea, vomiting, photosensitization). Patients with x 3 upper reference blood parameters are excluded. If values rise 50%, new sample within 3 days and ALA-ECP postponed. If persistent beyond 6 days - ALA-ECP postponed till normalization. Treatment stoped if identified SAE occur. ;Timepoint(s) of evaluation of this end point: For safety/tolerability; continuous evalution before and after every treatment. Main evaluations at 13, 26, 38, 50, 64 weeks and t

—

Secondary

Measure	Time frame
Secondary end point(s): Response/effectiveness of treatment after 13, 26, 38, 50, 64 weeks and three months after last treatment will be evaluated with baseline visit (prior treatment) as reference for the first 5 patients. The latter 5 will be assessed at 13 and 28 weeks. The efficacy parameters include SES-CD, Calprotectin and IBDQ in addition to clinical effect with HBI reduction > 3 from baseline but not remission. Mechanism of action and identification of biomarkers. ;Timepoint(s) of evaluation of this end point: Endoscopy and SES-CD will be done at week 13 and (if eligible for study extension with treatment every 4 weeks from week 14-62) at week 64 for the first 5 patients. The latter 5 patients will have an endoscopy at week 13. Remaining values will be collected at week 13, 26, 38, 50, 62 and 3 months after last treatment (IBDQ, calprotectin, HBI) if eligible for extension for the first 5 patients and in week 28 for patients not eligible for study extension. For the latter 5 patients - the values will be collected at week 13 and 28. Mechanism of action and identification of biomarkers will be done on blood, biopsies and buffy samples throughout the trial. That is ALA-induced PpIX and PDT effects on various sub populations of leukocytes in all samples.	—

Measure

Time frame

Secondary end point(s): Response/effectiveness of treatment after 13, 26, 38, 50, 64 weeks and three months after last treatment will be evaluated with baseline visit (prior treatment) as reference for the first 5 patients. The latter 5 will be assessed at 13 and 28 weeks. The efficacy parameters include SES-CD, Calprotectin and IBDQ in addition to clinical effect with HBI reduction > 3 from baseline but not remission. Mechanism of action and identification of biomarkers. ;Timepoint(s) of evaluation of this end point: Endoscopy and SES-CD will be done at week 13 and (if eligible for study extension with treatment every 4 weeks from week 14-62) at week 64 for the first 5 patients. The latter 5 patients will have an endoscopy at week 13. Remaining values will be collected at week 13, 26, 38, 50, 62 and 3 months after last treatment (IBDQ, calprotectin, HBI) if eligible for extension for the first 5 patients and in week 28 for patients not eligible for study extension. For the latter 5 patients - the values will be collected at week 13 and 28. Mechanism of action and identification of biomarkers will be done on blood, biopsies and buffy samples throughout the trial. That is ALA-induced PpIX and PDT effects on various sub populations of leukocytes in all samples.

—

Countries

Norway

Contacts

Public ContactProject Leader

Akershus University Hospital

kre5@ahus.no

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026