A Phase 2 interventional study of LFG316 and Conventional Therapy in Non-infectious Intermediate Uveitis, Non-infectious Posterior Uveitis and Non-infectious Panuveitis, sponsored by Novartis Pharmaceuticals. Completed at 8 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-05.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 2, Interventional, and Treatment
This was a multi-center, randomized, active-controlled, open-label study. Approximately 24 patients with active, non-infectious intermediate-, posterior-, or panuveitis requiring systemic immunosuppressive therapy were enrolled.
Safety, efficacy, and PK assessments occurred at scheduled visits over a 12-week period. Low-molecular-weight non-steroidal immunosuppressive medications were allowed up to the baseline day as long as the dose had not changed in the 3 weeks prior to baseline, except for corticosteroid doses for which might have changed.
Patients responding to treatment were offered up to 6 months of extended treatment. Assessments for safety included laboratory safety tests, ECGs, physical exams, ocular exams, vital signs and the monitoring of adverse events. Study participation varied from a minimum of 3 months to a maximum of 9 months.
Approximately 24 patients with active non-infectious uveitis, in at least one eye, requiring intensification of systemic immunosuppressive therapy were enrolled and randomized to receive intravitreal LFG316 or conventional therapy (investigator's discretion). Only one eye (the study eye) were treated with LFG316 and the other eye (fellow eye) were treated at the investigator's discretion.Throughout the study, the fellow eye might have been treated as needed; except that certain systemic medications were prohibited. There was 1 screening and 8 scheduled visits over 85 days for a total of 9 site visits for all patients.
At Day 85, patients receiving LFG316 treatment who met the criteria for a 'responder', were offered an additional 6 months of LFG316 treatment on a PRN basis. Additional 3 scheduled visits were attended by LFG316-responder patients during the extension period. However, patients could have unscheduled visits as needed and as determined by the investigator. Safety evaluation and ocular assessments were performed throughout the study duration. Patients in the treatment extension phase, who experienced a flare post their last dose and required treatment, might have received a dose of LFG316. These patients were assessed for a response at their next PRN visit as scheduled by the investigator. Visit frequency was determined by the investigator. If they continued to respond to LFG316 therapy, they might have remained in the PRN treatment arm. They might have received up to 7 additional doses of LFG316 in the PRN period. Throughout the trial LFG316 were not administered more frequently than monthly. Patients in the extension phase, who discontinued treatment prematurely were asked to return approximately 1 month after their last dose. Low molecular weight non-steroidal immunosuppressive medications were allowed up to the baseline day as long as the dose had not changed in the 3 weeks prior to baseline, except for corticosteroid doses which might have changed.
39 studies on the registry are indexed under Panuveitis; 4 are open to participants now.
This study's enrollment of 25 is below the median of 40 across 29 interventional studies indexed under Panuveitis.
Browse Panuveitis studies →Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Visual acuity (ETDRS method) of 20 letters (20/400 Snellen equivalent) or better in the study eye.
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: LFG316
Drug: Conventional Therapy
LFG316 administered intravitreally (IVT)
Conventional Therapy administered in accordance with its prescribing info.
Number of Participants With Response Rate for the Individual Response Criteria - in the Study Eye
Response rate as defined by: 1. An improvement of 2 or more steps in vitreous haze (scale of 0 to 4), relative to baseline OR 2. An improvement of 10 or more letters in visual acuity (VA), relative to baseline OR 3. An improvement of 2 or more steps in anterior chamber cells (ACC) score (scale of 0 to 4), relative to baseline OR 4. Absence of chorioretinal lesions as determined by the investigator
Time frame: Day 85 (end of study)
Number of Participants With Remission in Study Eye - Treatment Period
Remission (complete response) was defined as any patient who had: * a vitreous haze score of 0 or 0.5 (scale of 0 to 4) in the study eye, AND * an anterior chamber cell score of 0 (scale of 0 to 4), AND * no chorioretinal lesions in the study eye, AND * was off all immune modulatory therapy (systemic, corticosteroids and topical), AND * without any worsening of uveitis during the trial.
Time frame: Day 85 (end of study)
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Vitreous haze score (based on funduscopic exam): 0, 0.5/Trace, 1+, 2+, 3+, 4+ Vitreous haze score (scale of 0 to 4) with a score of 4 being the most hazed.
Time frame: Day 2, 8, 15, 29, 43, 57 and, 85 (end of the study)
Mean Best Corrected Visual Acuity (BCVA) in Study Eye - Treatment Period
Visual acuity was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) eye charts under ETDRS conditions. ETDRS best-corrected visual acuity was obtained in each eye separately under certified ETDRS conditions. This assessment was to be performed prior to pupil dilation. The number of letters read correctly (for each eye) was recorded. BCVA is based on the number of letters read correctly.
Time frame: Day 2, 8, 15, 29, 43, 57 and, 85 (end of the study)
Number of Patients With Macular Edema in Study Eye - Treatment Period
Macular edema is a sign of uveitis.
Time frame: Day 85 (end of study)
Number of Patients With Chorioretinal Lesions in Study Eye - Treatment Period
Chorioretinal lesions is a sign of uveitis.
Time frame: Day 2, 8, 15, 29, 43, 57 and, 85 (end of the study)
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
anterior chamber cells score (ACCS) with the scores being 0 (≤ 1 cell), 0.5 (1 to 5 aqueous cells), 1 (6 to 15 aqueous cells), 2 (16 to 25 aqueous cells), 3 (26 to 50 aqueous cells), 4 (\>50 aqueous cells).
Time frame: Day 2, 8, 15, 29, 43, 57 and, 85 (end of the study)
Number of Participants With or Without Anti-LFG316 Antibodies
Blood will be collected at each visit for the profiling of serum drug concentrations. The summary of immunogenicity (IG) by visit . The immunogenicity data (presence/absence of anti-LFG316 antibodies \[anti-drug antibodies\]). NO: No immunogenicity; YES: Positive immunogenicity.
Time frame: Throughout the study (treatment and extension period), up to day 271
Mean Percent Change in Total C5 Concentrations in Serum - Treatment Period
Percent change from baseline (using each patient's pre-dose value as baseline) in total C5 concentrations.
Time frame: Day 2, 15, 29, 43, 57 and, 85 (end of the study)
| Milestone | LFG316 | Conventional Therapy |
|---|---|---|
| Started | 18 | 7 |
| Completed | 16 | 7 |
| Not completed | 2 | 0 |
| Withdrew: Adverse event | 2 | 0 |
| Milestone | LFG316 | Conventional Therapy |
|---|---|---|
| Started | 5 | 0 |
| Completed | 4 | 0 |
| Not completed | 1 | 0 |
| Withdrew: Administrative problems | 1 | 0 |
Response rate as defined by: 1. An improvement of 2 or more steps in vitreous haze (scale of 0 to 4), relative to baseline OR 2. An improvement of 10 or more letters in visual acuity (VA), relative to baseline OR 3. An improvement of 2 or more steps in anterior chamber cells (ACC) score (scale of 0 to 4), relative to baseline OR 4. Absence of chorioretinal lesions as determined by the investigator
| Participants | LFG316 | Conventional Therapy |
|---|---|---|
| Improvement of vitreous haze ≥2 steps (N=15,6) | 3 | 3 |
| Improvement of VA ≥ 10 letters (N=15,6) | 0 | 1 |
| Improvement of ACC score ≥2 steps (N=7, 1) | 0 | 0 |
| Resolution of chorioretinal lesions (N= 3, 0) | 0 | — |
Remission (complete response) was defined as any patient who had: * a vitreous haze score of 0 or 0.5 (scale of 0 to 4) in the study eye, AND * an anterior chamber cell score of 0 (scale of 0 to 4), AND * no chorioretinal lesions in the study eye, AND * was off all immune modulatory therapy (systemic, corticosteroids and topical), AND * without any worsening of uveitis during the trial.
| Participants | LFG316 | Conventional Therapy |
|---|---|---|
| Number of Participants With Remission in Study Eye - Treatment Period | 2 | 0 |
Vitreous haze score (based on funduscopic exam): 0, 0.5/Trace, 1+, 2+, 3+, 4+ Vitreous haze score (scale of 0 to 4) with a score of 4 being the most hazed.
| Participants | LFG316 | Conventional Therapy |
|---|---|---|
| Day 2 — 0 | 0 | 0 |
| Day 2 — 0.5/Trace | 2 | 1 |
| Day 2 — 1+ | 10 | 4 |
| Day 2 — 2+ | 1 | 1 |
| Day 2 — 3+ | 2 | 1 |
| Day 2 — 4+ | 0 | 0 |
| Day 8 — 0 | 0 | 0 |
| Day 8 — 0.5/Trace | 1 | 0 |
| Day 8 — 1+ | 4 | 1 |
| Day 8 — 2+ | 0 | 0 |
| Day 8 — 3+ | 1 | 0 |
| Day 8 — 4+ | 0 | 0 |
| Day 15 — 0 | 2 | 1 |
| Day 15 — 0.5/Trace | 3 | 1 |
| Day 15 — 1+ | 6 | 4 |
| Day 15 — 2+ | 3 | 1 |
| Day 15 — 3+ | 0 | 0 |
| Day 15 — 4+ | 2 | 0 |
| Day 29 — 0 | 0 | 3 |
| Day 29 — 0.5/Trace | 4 | 1 |
| Day 29 — 1+ | 10 | 3 |
| Day 29 — 2+ | 0 | 0 |
| Day 29 — 3+ | 0 | 0 |
| Day 29 — 4+ | 1 | 0 |
| Day 43 — 0 | 6 | 2 |
| Day 43 — 0.5/Trace | 1 | 3 |
| Day 43 — 1+ | 6 | 1 |
| Day 43 — 2+ | 0 | 0 |
| Day 43 — 3+ | 0 | 0 |
| Day 43 — 4+ | 1 | 0 |
| Day 57 — 0 | 5 | 2 |
| Day 57 — 0.5/Trace | 5 | 2 |
| Day 57 — 1+ | 4 | 3 |
| Day 57 — 2+ | 0 | 0 |
| Day 57 — 3+ | 0 | 0 |
| Day 57 — 4+ | 0 | 0 |
| Day 85 (end of study) — 0 | 2 | 1 |
| Day 85 (end of study) — 0.5/Trace | 6 | 3 |
| Day 85 (end of study) — 1+ | 3 | 2 |
| Day 85 (end of study) — 2+ | 3 | 0 |
| Day 85 (end of study) — 3+ | 1 | 0 |
| Day 85 (end of study) — 4+ | 0 | 0 |
Visual acuity was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) eye charts under ETDRS conditions. ETDRS best-corrected visual acuity was obtained in each eye separately under certified ETDRS conditions. This assessment was to be performed prior to pupil dilation. The number of letters read correctly (for each eye) was recorded. BCVA is based on the number of letters read correctly.
| letters | LFG316 | Conventional Therapy |
|---|---|---|
| Day 2 | 72.5 ± 19.36 | 76.1 ± 0.7 |
| Day 8 | 80.5 ± 11.69 | 79.0 ± 79 |
| Day 15 | 68.8 ± 18.53 | 78.9 ± 9.10 |
| Day 29 | 70.3 ± 19.39 | 79.6 ± 9.47 |
| Day 43 | 65.5 ± 24.45 | 77.3 ± 9.07 |
| Day 57 | 72.6 ± 14.79 | 80.1 ± 10.35 |
| Day 85 | 72.1 ± 15.53 | 76.7 ± 10.25 |
Macular edema is a sign of uveitis.
| Participants | LFG316 | Conventional Therapy |
|---|---|---|
| Day 2 | 2 | 1 |
| Day 8 | 1 | 1 |
| Day 15 | 3 | 0 |
| Day 29 | 2 | 0 |
| Day 43 | 2 | 0 |
| Day 57 | 2 | 0 |
| Day 85 (end of study) | 2 | 0 |
Chorioretinal lesions is a sign of uveitis.
| Participants | LFG316 | Conventional Therapy |
|---|---|---|
| Day 2 | 3 | 0 |
| Day 8 | 2 | 0 |
| Day 15 | 4 | 0 |
| Day 29 | 5 | 0 |
| Day 43 | 4 | 0 |
| Day 57 | 5 | 1 |
| Day 85 (end of study) | 4 | 1 |
anterior chamber cells score (ACCS) with the scores being 0 (≤ 1 cell), 0.5 (1 to 5 aqueous cells), 1 (6 to 15 aqueous cells), 2 (16 to 25 aqueous cells), 3 (26 to 50 aqueous cells), 4 (\>50 aqueous cells).
| Participants | LFG316 | Conventional Therapy |
|---|---|---|
| Day 2 — 0; <1 cell | 2 | 0 |
| Day 2 — 0.5; 1-5 cells | 4 | 1 |
| Day 2 — 1; 6-15 cells | 1 | 0 |
| Day 2 — 2; 16-25 cells | 0 | 0 |
| Day 2 — 3; 26-50 cells | 0 | 0 |
| Day 2 — 4; >50 cells | 0 | 0 |
| Day 8 — 0; <1 cell | 2 | 0 |
| Day 8 — 0.5; 1-5 cells | 4 | 1 |
| Day 8 — 1; 6-15 cells | 0 | 0 |
| Day 8 — 2; 16-25 cells | 0 | 0 |
| Day 8 — 3; 26-50 cells | 0 | 0 |
| Day 8 — 4; >50 cells | 0 | 0 |
| Day 15 — 0; <1 cell | 3 | 1 |
| Day 15 — 0.5; 1-5 cells | 4 | 0 |
| Day 15 — 1; 6-15 cells | 1 | 0 |
| Day 15 — 2; 16-25 cells | 0 | 0 |
| Day 15 — 3; 26-50 cells | 0 | 0 |
| Day 15 — 4; >50 cells | 0 | 0 |
| Day 29 — 0; <1 cell | 2 | 1 |
| Day 29 — 0.5; 1-5 cells | 5 | 0 |
| Day 29 — 1; 6-15 cells | 0 | 0 |
| Day 29 — 2; 16-25 cells | 0 | 0 |
| Day 29 — 3; 26-50 cells | 0 | 0 |
| Day 29 — 4; >50 cells | 0 | 0 |
| Day 43 — 0; <1 cell | 5 | 1 |
| Day 43 — 0.5; 1-5 cells | 0 | 0 |
| Day 43 — 1; 6-15 cells | 1 | 0 |
| Day 43 — 2; 16-25 cells | 1 | 0 |
| Day 43 — 3; 26-50 cells | 0 | 0 |
| Day 43 — 4; >50 cells | 0 | 0 |
| Day 57 — 0; <1 cell | 5 | 1 |
| Day 57 — 0.5; 1-5 cells | 1 | 1 |
| Day 57 — 1; 6-15 cells | 2 | 0 |
| Day 57 — 2; 16-25 cells | 0 | 0 |
| Day 57 — 3; 26-50 cells | 0 | 0 |
| Day 57 — 4; >50 cells | 0 | 0 |
| Day 85 — 0; <1 cell | 4 | 3 |
| Day 85 — 0.5; 1-5 cells | 5 | 0 |
| Day 85 — 1; 6-15 cells | 0 | 0 |
| Day 85 — 2; 16-25 cells | 0 | 0 |
| Day 85 — 3; 26-50 cells | 0 | 0 |
| Day 85 — 4; >50 cells | 0 | 0 |
Blood will be collected at each visit for the profiling of serum drug concentrations. The summary of immunogenicity (IG) by visit . The immunogenicity data (presence/absence of anti-LFG316 antibodies \[anti-drug antibodies\]). NO: No immunogenicity; YES: Positive immunogenicity.
| Participants | LFG316 |
|---|---|
| Day 1 — participants with anti-LFG316 antibodies | 3 |
| Day 1 — participants without anti-LFG316 antibodies | 12 |
| Day 29 — participants with anti-LFG316 antibodies | 3 |
| Day 29 — participants without anti-LFG316 antibodies | 10 |
| Day 85 (end of study) — participants with anti-LFG316 antibodies | 2 |
| Day 85 (end of study) — participants without anti-LFG316 antibodies | 9 |
| Day 169 — participants with anti-LFG316 antibodies | 1 |
| Day 169 — participants without anti-LFG316 antibodies | 1 |
| Day 253 — participants with anti-LFG316 antibodies | 0 |
| Day 253 — participants without anti-LFG316 antibodies | 1 |
| End of extension period — participants with anti-LFG316 antibodies | 1 |
| End of extension period — participants without anti-LFG316 antibodies | 0 |
Percent change from baseline (using each patient's pre-dose value as baseline) in total C5 concentrations.
| Percent change in C5 | LFG316 | Conventional Therapy |
|---|---|---|
| Day 2 | 6.80 ± 14.5 | 1.02 ± 5.69 |
| Day 15 | 8.21 ± 15.3 | -1.27 ± 19.7 |
| Day 29 | 10.6 ± 17.4 | -8.33 ± 17.5 |
| Day 43 | 8.38 ± 13.4 | 6.46 ± 18.6 |
| Day 57 | 6.73 ± 12.0 | 5.98 ± 40.9 |
| Day 85 | 3.21 ± 22.1 | 1.28 ± 31.3 |
Collected over Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LFG316 | 0/18 (0%) | 1/18 (5.6%) | 11/18 (61.1%) |
| Conventional Therapy | 0/7 (0%) | 0/7 (0%) | 5/7 (71.4%) |
| Event | LFG316 | Conventional Therapy |
|---|---|---|
| Retinal detachmentEye disorders | 1/18 | 0/7 |
| Retinopathy proliferativeEye disorders | 1/18 | 0/7 |
| Mycotic endophthalmitisInfections and infestations | 1/18 | 0/7 |
| Event | LFG316 | Conventional Therapy |
|---|---|---|
| Conjunctival haemorrhageEye disorders | 4/18 | 0/7 |
| UveitisEye disorders | 4/18 | 0/7 |
| Intraocular pressure increasedInvestigations | 3/18 | 0/7 |
| Dry eyeEye disorders | 1/18 | 1/7 |
| Hypotony of eyeEye disorders | 0/18 | 1/7 |
| Macular fibrosisEye disorders | 1/18 | 1/7 |
| Ocular hypertensionEye disorders | 0/18 | 1/7 |
| Oral candidiasisInfections and infestations | 0/18 | 1/7 |
| PharyngitisInfections and infestations | 0/18 | 1/7 |
| Tooth infectionInfections and infestations | 0/18 | 1/7 |
Safety analysis set (SAS): All patients who received study drug (LFG316 or conventional treatment) were included in the safety analysis set.
| Age, Continuous(Years) | LFG316 | Conventional Therapy | Total |
|---|---|---|---|
| Mean | 45.3 ± 14.84 | 39.1 ± 14.89 | 43.6 ± 14.81 |
| Sex: Female, Male(Participants) | LFG316 | Conventional Therapy | Total |
|---|---|---|---|
| Female | 7 | 4 | 11 |
| Male | 11 | 3 | 14 |
| Ethnicity (NIH/OMB)(Participants) | LFG316 | Conventional Therapy | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 0 | 2 |
| Not Hispanic or Latino | 16 | 7 | 23 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | LFG316 | Conventional Therapy | Total |
|---|---|---|---|
| Caucasian | 17 | 6 | 23 |
| Black | 1 | 1 | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Studies of the drug tested here: Tesidolumab