Uveitis, PosteriorPhase 4NCT06085079
Ixekizumab for the Management of Refractory Non-Infectious Uveitis: A Proof-of-Concept Study
A Phase 4 study testing Ixekizumab Prefilled Syringe in people with Uveitis, Posterior and Uveitis, Anterior, run by Massachusetts Eye Research and Surgery Institution at 1 site in United States.
Trial summary
The objective of this study is to explore the efficacy of ixekizumab in treating patients with a diagnosis of non-infectious intermediate, posterior, panuveitis, or chronic steroid-dependent anterior uveitis who had failed treatment with a classic synthetic DMARD including methotrexate, mycophenolate, cyclosporin… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Uveitis, Posterior, Uveitis, Anterior, Uveitis, Intermediate
- What is being tested?
- Ixekizumab Prefilled Syringe
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 30 Dec 2024
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Diagnosis of non-infectious intermediate, posterior, panuveitis, or chronic steroid dependent anterior uveitis
- Failure of at least one classic synthetic DMARD including Methotrexate, Mycophenolate, Cyclosporin, Azathioprine, Cyclophosphamide, and/or at least one anti-TNF agent including Adalimumab, Infliximab, Etanercept, Golimumab or Certolizumab
- Active disease at screening visit
- At least 1 of the following parameters in at least one eye:
- active inflammatory chorioretinal and/or inflammatory retinal vascular lesions
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- ≥ 1+ vitreous haze (Nussenblatt criteria)
- ≥ 2+ anterior chamber cells (National Eye Institute/Standardization of Uveitis Nomenclature criteria)
- Cystoid macular edema, seen on optical coherence tomography and/or fluorescein angiography
- FA leakage pattern deemed by investigators to be suggestive of active intermediate, posterior, and panuveitis, including optic disc, retinal vascular, and macular leakages
- Active snowbanking
Who cannot join
- The presence of only acute anterior uveitis.
- Serpiginous choroidopathy
- Subject with prior inadequate response to high-dose oral corticosteroids (> 60 mg of prednisone)
- Subject with confirmed or suspected infectious uveitis
- Patients with intraocular pressure of ≥ 25 mmHg or evidence of optic nerve injury
- Corneal or lens opacity that precludes adequate ophthalmic evaluation.
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- Patients likely to undergo cataract surgery during the duration of the trial.
- Patients with Best Corrected Visual Acuity (BCVA) less than 20 letters (Early Treatment Diabetic Retinopathy Study)
- Dose of concomitant immunosuppressive therapy at the baseline visit:
- Methotrexate (MTX) ˃ 25 mg per week
- Cyclosporine ˃ 4 mg/kg per day
- Mycophenolate mofetil ˃ 3 grams per day or an equivalent drug to mycophenolate mofetil (e.g. mycophenolic acid) at an equivalent dose approved by the medical monitor.
- Azathioprine ˃ 175 mg per day
- Tacrolimus (oral formulation) > 8 mg per day
- If entering the study on 1 concomitant immunosuppressive therapy, dose has been increased within the last 28 days prior to Baseline visit.
- Subject has received Retisert® (implant) within 3 years prior to the Baseline visit or that has had complications related to the device. Subject has had Retisert® (implant) removed within 90 days prior to the Baseline visit or has had complications related to the removal of the device
- Subject has received intraocular or periocular corticosteroids within 30 days prior to Baseline visit
- Subject with proliferative or severe non-proliferative diabetic retinopathy or clinically significant macular edema due to diabetic retinopathy
- Subject with neovascular/wet age-related macular degeneration
- Subject with abnormality of vitreo-retinal interface (i.e., vitreomacular traction, epiretinal membranes, etc.) with the potential for macular structural damage independent of the inflammatory process, deemed macular pathology is deemed by a retinal specialist to be a potential cofounder of patient's visual acuity reduction
- Subject with severe vitreous haze that precludes visualization of the fundus at the baseline visit
- Subject has received Ozurdex® (dexamethasone implant) within 6 months prior to the baseline visit
- Subject has received intravitreal anti-VEGF therapy within 45 days of the Baseline visit for Lucentis® (ranibizumab) or Avastin® (bevacizumab) or within 60 days of the Baseline visit for anti-VEGF Trap (aflibercept)
- Subject has received intravitreal methotrexate within 90 days prior to the Baseline visit
- Subject on systemic carbonic anhydrase inhibitor within 1 week prior to Screening visit
- Subject with macular edema as the only sign of uveitis
- Subject with a history of scleritis
- Subject with intolerance to high-dose oral corticosteroids (equivalent of oral prednisone 1 mg/kg/day or 60 to 80 mg/day)
- Subject on cyclophosphamide within 30 days prior to the Baseline visit
- Participation in other investigational drug or device clinical trials within 30 days prior to Day 0 or planning to participate in other investigational drug or device clinical trials within 180 days following 48 weeks after day 0. This includes both ocular and non-ocular clinical trials
- Major surgery within 8 weeks prior to screening or planned major surgery within 6 months following randomization
- Treatment with intravenous gamma globulin or plasmapheresis during the course of the trial
- Immunization with a live/attenuated vaccine within 4 weeks prior to baseline
- History of severe allergic or anaphylactic reactions to human, humanized monoclonal antibodies
- Prior history of Crohn's Colitis or Ulcerative Colitis
- Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (include uncontrolled diabetes mellitus) or gastrointestinal disease (including complicated diverticulitis, liver disease or peptic ulcer disease)
- Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections (including but not limited to tuberculosis and atypical mycobacterial disease, Hepatitis B and C, and herpes zoster, but excluding fungal infections of nail beds)
- Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening
- Active tuberculosis (TB) requiring treatment within the previous 3 years. Patients should be screened for latent TB and, if positive, treated following local practice guidelines prior to initiating trial. Patients treated for tuberculosis with no recurrence in 3 years are permitted
- Primary or secondary immunodeficiency (history of or currently active)
- Evidence of active malignant disease, malignancies diagnosed within the previous 5 years (including hematological malignancies and solid tumors, except basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that has been excised and cured)
- Pregnant women or breast-feeding mothers
- Patients with reproductive potential not willing to use an effective method of contraception
- History of alcohol, drug, or chemical abuse within 1 year prior to screening.
- Serum creatinine > 1.6 mg/dL (141 μmol/L) in female patients and > 1.9 mg/dL (168 μmol/L) in male patients. Patients with serum creatinine values exceeding limits may be eligible for the study if their estimated glomerular filtration rates (GFR) are >30.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 times upper limit of normal (ULN)
- Total Bilirubin > 1.5 ULN
- Platelet count < 100 x 109/L (100,000/mm3)
- Hemoglobin < 85 g/L (8.5 g/dL; 5.3 mmol/L)
- White Blood Cells < 3.0 x 109/L (3000/mm3)
- Absolute Neutrophil Count < 2.0 x 109/L (2000/mm3)
- Absolute Lymphocyte Count < 0.5 x 109/L (500/mm3)
- Positive Hepatitis BsAg, or Hepatitis C antibody
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Massachusetts Eye Research and Surgery Institution
Waltham, Massachusetts, 02451
Tate Valerio, BA, 781-647-1431 ext. 401, tvalerio@mersi.com
Yasmin Massoudi, BS, 7816471431 ext. 402, ymassoudi@mersi.com
About this study
Official title: A 24-week Two-armed Proof-of-concept Exploratory Analysis of Subcutaneous Ixekizumab Administration in Patients With Recalcitrant Non-infectious Intermediate, Posterior, Panuveitis, or Chronic Steroid-dependent Anterior Uveitis.
The objective of this study is to explore the efficacy of ixekizumab in treating patients with a diagnosis of non-infectious intermediate, posterior, panuveitis, or chronic steroid-dependent anterior uveitis who had failed treatment with a classic synthetic DMARD including methotrexate, mycophenolate, cyclosporin, azathioprine, cyclophosphamide and/or at least one anti-TNF agent including adalimumab, infliximab, etanercept, golimumab or certolizumab.
Read the detailed description
This is a 24-week open label analysis of subcutaneous ixekizumab (taltz) in patients with non-infectious intermediate, posterior, panuveitis, and chronic steroid-dependent anterior uveitis. The study visits are held at Massachusetts Eye Research and Surgery Institution (MERSI) in Waltham, Massachusetts. The study is aiming to enroll 20 subjects. This is a two-armed study in which Group A receives ixekizumab every 2 weeks and Group B receives ixekizumab every 4 weeks.
- Being tested
- Ixekizumab Prefilled Syringe
- Medical subject headings
- Uveitis, Posterior, Uveitis, Anterior, Uveitis, Intermediate, Panuveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ixekizumab Prefilled SyringeDrug
Ixekizumab is a humanized IgG4 monoclonal antibody that binds with high affinity and specificity to IL-17A. This medication is currently approved for the treatment of plaque Ps, ankylosing spondylitis, and psoriatic arthritis.
| Study group | Role | What they receive |
|---|---|---|
| 2-week dosing | Experimental | Subjects will self-administer subcutaneous injection of ixekizumab during the baseline week (Week 0) using a loading dose of 160 mg of subcutaneous ixekizumab (Taltz), followed by 80 mg of subcutaneous ixekizumab Q2 weeks for 24-weeks. Receives: Drug: Ixekizumab Prefilled Syringe |
| 4-week dosing | Experimental | Subjects will self-administer subcutaneous injection of ixekizumab during the baseline week (Week 0) using a loading dose of 160 mg of subcutaneous ixekizumab (Taltz), followed by 80 mg of subcutaneous ixekizumab Q4 weeks for 24-weeks. Receives: Drug: Ixekizumab Prefilled Syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response
The four components of the composite endpoint will each be graded dichotomously (i.e., yes, or no for success), and include visual acuity, control of inflammation, tapering of medication therapy, and reduction of cystoid macular edema. Clinical response will be defined by improvement in at least one parameter with worsening in none, and well controlled intraocular inflammation.
Measured: Assessed around week 10
Secondary outcomes (3)
Intraocular pressure
Intraocular pressure is a number between 0 and 100 mmHg, with most values ranging from 5-30 and normal of 10-21.
Measured: This will be measured and assessed throughout the entire 24-week study period up until the patient's final visit.
Subjective Visual Benefit
The National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25) will measure the patient's assessment of his or her vision and problems and how these problems impact their quality of life. Responses are quantified numerically for each section. These responses have specific ranges: 1 to 6 for "General Health and Vision" (section 1, with lower number response signifying better health outcomes); 1 to 6 for "Difficulties with Activities" (section 2, with lower number response signifying less difficulty with activities); 1-5 for "Responses to Vision Problems" (section 3, with lower number response signifying more negative responses to vision problems).
Measured: This will be measured and assessed throughout the entire 24-week study period up until the patient's final visit.
Adverse Event frequency
The following safety endpoints will be measured: allergic reactions, hypersensitivity, malignancies, infections (upper respiratory tract, urinary tract, sinusitis, tonsillitis, bronchitis, cystitis), serious infections, candidiasis, MACE, Crohn's disease, ulcerative colitis, injection site reactions (mild, moderate, severe), diarrhea, depression, muscle spasm, hypertension, osteoarthritis, psoriatic arthritis, fatigue, headache, back pain, LFT elevation, lipid elevation, cerebro-cardiovascular events, depression/suicide, death. The development or worsening of any medical problems will be documented through adverse event monitoring at each study visit. The frequency of each adverse event across all subjects will be calculated.
Measured: This will be monitored and assessed throughout the entirety of the 24-week study period and through 30 days following the last administration of study treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start1 Jun 2022
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveitis, PosteriorStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm 1: Subjects will self-administer subcutaneous injection of ixekizumab during the baseline week (Week 0) using a loading dose of 160 mg of subcutaneous ixekizumab (Taltz), followed by 80 mg of subcutaneous ixekizumab Q2 weeks for 24-weeks. Arm 2: Subjects will self-administer subcutaneous injection of ixekizumab during the baseline week (Week 0) using a loading dose of 160 mg of subcutaneous ixekizumab (Taltz), followed by 80 mg of subcutaneous ixekizumab Q4 weeks for 24-weeks.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye Research and Surgery Institution
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- C. Stephen Foster, MD, FACS, FACR, Principal investigator, Founder of research site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085079
- Sponsor's protocol ID
- IXE-1001
- Status last verified
- Oct 2023
- First submitted
- 3 Apr 2023
- Last updated
- 16 Oct 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-week Two-armed Proof-of-concept Exploratory Analysis of Subcutaneous Ixekizumab Administration in Patients With Recalcitrant Non-infectious Intermediate, Posterior, Panuveitis, or Chronic Steroid-dependent Anterior Uveitis.
- ClinicalTrials.gov ID
- NCT06085079
- Acronym / sponsor ID
- IXE-1001
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Massachusetts Eye Research and Surgery InstitutionUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 16 Oct 2023 (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 explore the efficacy of ixekizumab in treating patients with a diagnosis of non-infectious intermediate, posterior, panuveitis, or chronic steroid-dependent anterior uveitis who had failed treatment with a classic synthetic DMARD including methotrexate, mycophenolate, cyclosporin, azathioprine, cyclophosphamide and/or at least one anti-TNF agent including adalimumab, infliximab, etanercept, golimumab or certolizumab.
Detailed description
This is a 24-week open label analysis of subcutaneous ixekizumab (taltz) in patients with non-infectious intermediate, posterior, panuveitis, and chronic steroid-dependent anterior uveitis. The study visits are held at Massachusetts Eye Research and Surgery Institution (MERSI) in Waltham, Massachusetts. The study is aiming to enroll 20 subjects. This is a two-armed study in which Group A receives ixekizumab every 2 weeks and Group B receives ixekizumab every 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Arm 1: Subjects will self-administer subcutaneous injection of ixekizumab during the baseline week (Week 0) using a loading dose of 160 mg of subcutaneous ixekizumab (Taltz), followed by 80 mg of subcutaneous ixekizumab Q2 weeks for 24-weeks. Arm 2: Subjects will self-administer subcutaneous injection of ixekizumab during the baseline week (Week 0) using a loading dose of 160 mg of subcutaneous ixekizumab (Taltz), followed by 80 mg of subcutaneous ixekizumab Q4 weeks for 24-weeks.
| Arm | Type | Receives |
|---|---|---|
| 2-week dosing | Experimental | Drug: Ixekizumab Prefilled SyringeSubjects will self-administer subcutaneous injection of ixekizumab during the baseline week (Week 0) using a loading dose of 160 mg of subcutaneous ixekizumab (Taltz), followed by 80 mg of subcutaneous ixekizumab Q2 weeks for 24-weeks. |
| 4-week dosing | Experimental | Drug: Ixekizumab Prefilled SyringeSubjects will self-administer subcutaneous injection of ixekizumab during the baseline week (Week 0) using a loading dose of 160 mg of subcutaneous ixekizumab (Taltz), followed by 80 mg of subcutaneous ixekizumab Q4 weeks for 24-weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- At least 18 years of age
- Diagnosis of non-infectious intermediate, posterior, panuveitis, or chronic steroid dependent anterior uveitis
- Failure of at least one classic synthetic DMARD including Methotrexate, Mycophenolate, Cyclosporin, Azathioprine, Cyclophosphamide, and/or at least one anti-TNF agent including Adalimumab, Infliximab, Etanercept, Golimumab or Certolizumab
- Active disease at screening visit
- At least 1 of the following parameters in at least one eye:
Key exclusion criteria (53 listed)
- The presence of only acute anterior uveitis.
- Serpiginous choroidopathy
- Subject with prior inadequate response to high-dose oral corticosteroids (> 60 mg of prednisone)
- Subject with confirmed or suspected infectious uveitis
- Patients with intraocular pressure of ≥ 25 mmHg or evidence of optic nerve injury
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 |
|---|---|---|
| Ixekizumab Prefilled SyringeIxekizumab is a humanized IgG4 monoclonal antibody that binds with high affinity and specificity to IL-17A. This medication is currently approved for the treatment of plaque Ps, ankylosing spondylitis, and psoriatic arthritis. | Drug | 2-week dosing, 4-week dosing |
Primary outcome
Clinical response
Time frame: Assessed around week 10
The four components of the composite endpoint will each be graded dichotomously (i.e., yes, or no for success), and include visual acuity, control of inflammation, tapering of medication therapy, and reduction of cystoid macular edema. Clinical response will be defined by improvement in at least one parameter with worsening in none, and well controlled intraocular inflammation.
3 secondary outcomes
Intraocular pressure
Time frame: This will be measured and assessed throughout the entire 24-week study period up until the patient's final visit.
Subjective Visual Benefit
Time frame: This will be measured and assessed throughout the entire 24-week study period up until the patient's final visit.
Adverse Event frequency
Time frame: This will be monitored and assessed throughout the entirety of the 24-week study period and through 30 days following the last administration of study treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
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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.
C. Stephen Foster, MD, FACS, FACR principal investigator
Founder of research site
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ixekizumab Prefilled Syringe in people with Uveitis, Posterior and Uveitis, Anterior, run by Massachusetts Eye Research and Surgery Institution 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 11 inclusion and 53 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: status not confirmed, as of the sponsor's last update on 16 Oct 2023. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tate Valerio, BA (781-891-6377 ext. 401, tvalerio@mersi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response (time frame: Assessed around week 10). 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 16 Oct 2023.