Evaluating the efficacy and safety of hyperbaric oxygen therapy as an adjuvant treatment compared to biologic therapy alone in moderate to severe ulcerative colitis in adults

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Medical University Of Gdansk

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20], Diseases [C] - Digestive System Diseases [C06]

Trial duration

completed 10 Jul 2025

Decision date (initial)

2024-05-07

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Medical Research Agency (Agencja Badań Medycznych)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

Comparison of the effectiveness of biological treatment (group I, standard treatment) with combined treatment including biological treatment and hyperbaric oxygen therapy (group II, combined treatment).

Secondary objectives 1

1. Assessment of the effectiveness of biological treatment (group I, standard treatment) with combined treatment including biological treatment and hyperbaric oxygen therapy (group II, combined treatment) after 14 weeks and 12 months after the first dose

Conditions and MedDRA coding

Ulcerative colitis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 1. Patients with moderate or severe ulcerative colitis (disease severity score on the Mayo scale of at least 6 points, of which at least 2 points for endoscopy). 2. Histopathologically confirmed diagnosis of ulcerative colitis for at least 3 months. 3. In patients with a history of ulcerative colitis for 8 years or more: mandatory colonoscopy with control for dysplasia within the last year. 4. Patient's age: 18-70 years. 5. Lack of response to steroid treatment (steroid resistance or steroid dependence) OR lack of response to treatment with azathioprine or mercaptopurine defined as failure to achieve remission despite 12 weeks of treatment, or intolerance to such treatment, or contraindications to such treatment. 1. Steroid resistance - defined as lack of clinical improvement despite the use of a steroid at a daily dose of up to 0.75 mg/kg (calculated as prednisolone) for 4 weeks. 2. Steroid dependence - defined as the inability to reduce the dose of steroids below 10 mg/day (calculated as prednisolone) within 3 months of starting steroid therapy or the recurrence of symptoms within 3 months of discontinuing steroids. 6. Patients qualified for treatment with infliximab, vedolizumab or ustekinumab in the drug program.

Exclusion criteria 1

1. 1. Active viral, fungal or bacterial infection constituting a contraindication to biological or immunosuppressive treatment. 2. Malignancy (except pre-cancerous lesions and skin cancer other than melanoma) within the last 5 years. 3. Pregnancy or breastfeeding. 4. Moderate or severe heart failure. 5. Severe liver or kidney disease. 6. Unstable coronary artery disease. 7. Another coexisting disease which, in the opinion of the treating physician, is a contraindication to participation in the program. 8. Contraindications to hyperbaric oxygen treatment, including + middle ear disease + history of pneumothorax + bronchial asthma + chronic obstructive pulmonary disease + pulmonary emphysema + severe claustrophobia

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The percentage of clinical remission after 12 months of treatment, i.e. the percentage of patients who achieved complete resolution of clinical symptoms of exacerbation of ulcerative colitis (diarrhea and blood in the stool), as well as resolution of endoscopic markers of mucosal inflammation.

Secondary endpoints 1

1. 1. Assessment of the clinical response rate in the group of patients receiving combination therapy compared to the group of patients receiving biological therapy alone after 14 weeks and 12 months after administration of the first dose of biological drug. 2. Assessment of the percentage of complete clinical remission in the group of patients receiving combined treatment compared to the group of patients receiving biological treatment alone 14 weeks after administration of the first dose of the b

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medical University Of Gdansk

Sponsor organisation

Medical University Of Gdansk

Address

Ul. Marii Sklodowskiej-Curie 3a

City

Gdansk

Postcode

80-210

Country

Poland

Scientific contact point

Organisation

Medical University Of Gdansk

Contact name

Krystian Adrych

Public contact point

Organisation

Medical University Of Gdansk

Contact name

Krystian Adrych

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 15 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications